ULTRATHIN-STRUT BIODEGRADABLE POLYMER SIROLIMUS-ELUTING STENTS COMBINED WITH P2Y12 INHIBITOR-BASED SINGLE ANTIPLATELET THERAPY AFTER A SHORT DUAL ANTIPLATELET THERAPY REGIMEN VERSUS CONVENTIONAL DUAL ANTIPLATELET THERAPY FOR UNPROTECTED LEFT MAIN CORONARY ARTERY DISEASE

The management of patients with unprotected left main coronary artery (LMCA) disease undergoing percutaneous coronary intervention (PCI) in contemporary interventional cardiology practice remains matter of intense debate. Particularly, the combination of the optimal drug-eluting stent (DES) selection and antiplatelet regimen for patients who require LMCA PCI remains undetermined.
Newer-generation drug-eluting stents with ultrathin-strut metallic platforms have been shown to reduce the risk of target lesion failure compared with thicker-strut drug-eluting stents among all-comer patients undergoing PCI, a difference mainly driven by a lower risk of ischemia-driven target lesion revascularization. In the TALENT prospective, single-blind, multicenter, randomized controlled trial that included 1'435 all-comer patients undergoing PCI, the Supraflex ultrathin-strut biodegradable polymer sirolimus-eluting stent was found non-inferior to the Xience® thin-strut permanent polymer everolimus-eluting stent (Abbott Vascular, USA) with regards to the device-oriented composite clinical endpoint (DoCE), a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularization, at 12 months of follow-up. However, the TALENT trial included only 31 (1.5%) lesions located in the left main coronary artery. In the COMPARE 60/80 HBR investigator-initiated, multicenter, prospective randomized trial which included a total of 732 patients at high-bleeding risk undergoing PCI with the Supraflex Cruz ultrathin-strut biodegradable polymer sirolimus-eluting stent or the Ultimaster Tansei (Terumo Corp., Tokyo, Japan), the rates of the primary endpoint of the net adverse clinical endpoint, defined as a composite of cardiac death, myocardial infarction, target vessel revascularization, stroke, or BARC 3 or 5 major bleeding events at 12 months were similar in the Supraflex Cruz and the Ultimaster Tansei groups, meeting the prespecified criterion for non-inferiority of the Supraflex Cruz DES compared to the Ultimaster Tansei DES. The safety and efficacy of the Supraflex Cruz ultrathin-strut biodegradable polymer sirolimus-eluting stent combined with potent P2Y12 inhibitor aspirin-free SAPT among all-comer patients undergoing PCI for complex coronary lesions, such as patients with LMCA stenosis, have however not been investigated to date.
Recent evidence from a large-scale meta-analysis of several randomized clinical trials including >32'000 patients indicated that 1-3 months of DAPT followed by P2Y12 inhibitor single antiplatelet therapy (SAPT) after second-generation DES implantation was associated with lower risk for major bleeding and similar risk for adverse ischemic outcomes compared with conventional DAPT. These findings suggest that P2Y12 inhibitor SAPT following a short DAPT course (1-3 months) may represent a valuable treatment option for patients undergoing PCI with newer-generation DES compared to standard conventional 12 months DAPT, but this strategy has never been investigated in dedicated randomized clinical trials focused on patients at highest-risk for ischaemic events, such as patients undergoing LMCA PCI.
The ULTIMATE-LM randomized trial aims at filling this current gap of knowledge, which may have large impact on clinical practice and international guidelines. ULTIMATE-LM will be the first randomized clinical trial to investigate the safety and efficacy of a novel ultrathin-strut biodegradable polymer drug-eluting stent (Supraflex Cruz, Sahajanand Medical Technologies Ltd., Surat, India)) combined with P2Y12 inhibitor-based single antiplatelet therapy among patients undergoing PCI for LMCA disease.

Start Date01 May 2025

Sponsor / Collaborator

Les Hôpitaux Universitaires de Genève

[+1]

NCT06821191

/ Not yet recruitingPhase 4IIT

Comparison of Dual Antiplatelet Therapy De-escalation by Dose Reduction Versus Switching in Patients Undergoing PCI: A Prospective, Randomized Pharmacodynamic Study - The Switching Antiplatelet-8 (SWAP-8) Study

Dual antiplatelet therapy (DAPT) with low-dose aspirin and a P2Y12 inhibitor is the current standard of care in patients with coronary artery disease experiencing an acute event or undergoing percutaneous coronary intervention. However, the ischemic benefits are counterbalanced by a significant increase in bleeding events. Over time, different DAPT de-escalation strategies have been developed to reduce the bleeding risk while maintaining the ischemic protection, but there is currently no head-to-head comparison between them. The purpose of this clinical trial is to conduct a head-to-head comparison on the pharmacodynamic efficacy of DAPT de-escalation by dose reduction to low-dose prasugrel (5 mg od) and DAPT de-escation by switching from standard-dose more potent P2Y12 receptor inhibitor to standard-dose clopidogrel (75 mg). To determine if the PD profiles of these two strategies are comparable, we aim to conduct a non-inferiority study.

Start Date17 Feb 2025

Sponsor / Collaborator

University of Florida

NCT06691191

/ RecruitingPhase 4IIT

Switching From Dual Antiplatelet Therapy to Monotherapy With Potent P2Y12 Inhibitors: Pharmadodynamic Comparison Between Prasugrel and Ticagrelor Monotherapy. The Switching Antiplatelet -7 (SWAP-7) Study

Ticagrelor currently represents the most tested and commonly used P2Y12 inhibitor monotherapy following percutaneous coronary intervention. The purpose of this study is to conduct a head-to-head comparison on the pharmacodynamic efficacy of ticagrelor-based and prasugrel-based single antiplatelet therapy. To determine if the PD profiles of ticagrelor- and prasugrel-based SAPT are comparable, we aim to conduct a non-inferiority study between the two strategies.

Start Date08 Jan 2025

Sponsor / Collaborator

University of Florida

100 Clinical Results associated with Prasugrel Hydrochloride

100 Translational Medicine associated with Prasugrel Hydrochloride

100 Patents (Medical) associated with Prasugrel Hydrochloride

3,552

Literatures (Medical) associated with Prasugrel Hydrochloride

01 Apr 2025·Cardiovascular Intervention and Therapeutics

Safety of crushed/chewed P2Y12 inhibitors in acute coronary syndromes — a meta-analysis of randomized controlled trials

Review

Author: Kirov, Hristo ; Di Franco, Antonino ; Doenst, Torsten ; Moustafa, Amr Osama ; Pascalis, Luca ; Cardoso, Rhanderson ; Treml, Ricardo E ; Fazzini, Luca ; Caldonazo, Tulio ; Schulze, Christian

The administration of crushed or chewed P2Y12 inhibitors (P2Y12i) allows faster platelet inhibition in patients presenting acute coronary syndrome (ACS). Whether this administration approach is safe needs further analysis. We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing chewed/crushed to integral P2Y12i administration in patients with ACS. Major bleeding, minor bleeding, and major adverse cardiovascular events (MACE) were analyzed as binary outcomes. Platelet reactivity unit (PRU) was assessed as a continuous outcome to estimate the impact on platelet physiology. A subgroup analysis of P2Y12i administered was performed. Nine studies comprising 1091 patients with ACS were included, 77% were males. Overall, 87% presented with ST-segment elevation acute myocardial infarction. Six studies administered Ticagrelor, while 3 studies used Prasugrel. The absolute risk of bleeding, assessed by TIMI, was low in both intervention and control arms (0.36% vs. 0.95% for major bleedings and 3.3% vs. 4.4% for minor bleedings), and crushed/chewed administration did not increase the relative risk of bleeding events for TIMI major or minor bleedings (RR 0.51, 95% CI 0.09-2.77, p = 0.293; RR 0.76, 95% CI 0.24-2.43, p = 0.542) or MACE (RR 0.94, 95% CI 0.28-3.19, p = 0.902). PRU was significantly reduced within 1 h after administration in the crushed/chewed P2Y12i group (MD: -70.0%, 95% CI, -89.0 to -51.1%, p<0.01) while we did not observe a significant difference after 4 h (MD: -15.1%, 95% CI -34.2 to 4.0%, p = 0.12). The type of drug did not influence the relative risk of crushed/chewed P2Y12i on major or minor bleeding (p_interaction = 0.62 and p_interaction = 0.23_, respectively). The crushed/chewed administration of P2Y12i in the setting of ACS was not associated with an increased risk of bleeding, suggesting the safety of this strategy.

13 Mar 2025·European Heart Journal-Cardiovascular Pharmacotherapy

Aspirin vs. clopidogrel monotherapy beyond 1 month after complex percutaneous coronary intervention: a pre-specified subgroup analysis of the STOPDAPT-3 trial

Article

Author: Kimura, Takeshi ; Kawahatsu, Kando ; Natsuaki, Masahiro ; Tamura, Toshihiro ; Domei, Takenori ; Takenaka, Hiroyuki ; Isawa, Tsuyoshi ; Ando, Kenji ; Kawamura, Takayuki ; Hagikura, Arata ; Yamamoto, Ko ; Serikawa, Takeshi ; Nishikawa, Ryusuke ; Shibata, Naoki ; Ono, Koh ; Mori, Hiroyoshi ; Abe, Mitsuru ; Morimoto, Takeshi ; Obayashi, Yuki ; Hayashi, Fujio ; Ishikawa, Tetsuya ; Kimura, Tomoya ; Suwa, Satoru ; Watanabe, Hirotoshi

Abstract:

Aims:

There were no previous studies comparing aspirin vs. P2Y12 inhibitor monotherapy following short dual antiplatelet therapy (DAPT) after complex percutaneous coronary intervention (PCI).

Methods and results:

We conducted a pre-specified subgroup analysis based on complex PCI in the 1-year results of the STOPDAPT-3 (ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-3) trial, which randomly compared 1-month DAPT followed by aspirin monotherapy (aspirin group) with 1-month prasugrel monotherapy followed by clopidogrel monotherapy (clopidogrel group). The main analysis in the present study was the 30-day landmark analysis. The co-primary endpoints were cardiovascular events (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or stroke) and major bleeding (Bleeding Academic Research Consortium 3 or 5). In the 30-day landmark analysis (N = 5833), there were 1415 patients (24.3%) who underwent complex PCI. There was a significant interaction between complex PCI and the effect of the aspirin group relative to the clopidogrel group for cardiovascular events (complex PCI: 3.3% vs. 5.2%, non-complex PCI: 4.3% vs. 3.6%, interaction P = 0.04) and net adverse clinical events (complex PCI: 4.8% vs. 7.2%, non-complex PCI: 5.3% vs. 4.4%, interaction P = 0.02), but not for bleeding events (complex PCI: 2.1% vs. 2.7%, non-complex PCI: 1.7% vs. 1.4%, interaction P = 0.35).

Conclusions:

There was a significant interaction between complex PCI and the effect of aspirin monotherapy relative to clopidogrel monotherapy beyond 1 month and up to 1 year for cardiovascular events due to numerically lower risk of aspirin monotherapy in patients with complex PCI, while the effect of aspirin monotherapy relative to clopidogrel monotherapy was not different for bleeding regardless of complex PCI.

Clinical trial registration:

ShorT and OPtimal duration of Dual AntiPlatelet Therapy after everolimus-eluting cobalt-chromium stent-3 [STOPDAPT-3]; NCT04609111.

01 Mar 2025·JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY

Part 1: Management of antithrombotic medications in dermatologic surgery

Review

Author: Samie, Faramarz H ; Trager, Megan H ; Humphreys, Tatyana R ; Gordon, Emily R

Perioperative management of antithrombotic agents requires practical and medical considerations. Discontinuing antithrombotic therapies increases the risk of thrombotic adverse events including cerebrovascular accidents, myocardial infarction, pulmonary embolism, deep vein thrombosis, and retinal artery occlusion. Conversely, continuation of antithrombotic therapy during surgical procedures has associated bleeding risks. Currently, no guidelines exist regarding management of antithrombotic agents in the perioperative period for cutaneous surgeries and practice differs by surgeon. Here, we review the data on antithrombotic medications in patients undergoing cutaneous surgery including medication-specific surgical and postoperative bleeding risk if the medications are continued, and thromboembolic risk if the medications are interrupted. Specifically, we focus on vitamin K antagonist (warfarin), direct-acting oral anticoagulants (rivaroxaban, apixaban, edoxaban, dabigatran), antiplatelet medications (aspirin, clopidogrel, prasugrel, ticagrelor, dipyridamole), unfractionated heparin, low molecular weight heparin (enoxaparin and dalteparin), fondaparinux, bruton tyrosine kinase inhibitors (ibrutinib, acalabrutinib), and dietary supplements (ie, garlic, ginger, gingko).

News (Medical) associated with Prasugrel Hydrochloride

17 Dec 2024

·www.accesswire.com

Esteemed Harvard Medical School Professor Dr. Michael Gibson Appointed Chief Medical Advisor at Lexaria Bioscience

Dr. Gibson joining Lexaria's new scientific advisor board KELOWNA, BC / ACCESSWIRE / December 17, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces the appointment of Dr. Michael Gibson as its new Chief Medical Advisor. Dr. Gibson will collaborate directly with President John Docherty as Lexaria's patented DehydraTECH drug delivery platform continues to expand its applications in GLP-1 and hypertension.C. Michael Gibson M.S., M.D., is an interventional cardiologist, cardiovascular researcher & educator. He is the CEO of the combined non-profit Baim and PERFUSE research institutes at Harvard Medical School. Gibson founded PERFUSE in 1987 which served as the TIMI Data coordinating center that coordinated data for the first 50 TIMI trials. The Baim institute was formerly known as Harvard Clinical Research Institute and was founded in 2000.The combined institutes have led over 1,250 studies, published 5,500 manuscripts in peer review literature (including 144 in the New England Journal of Medicine) and have led 70 FDA submissions from their network of 7,000 sites in 57 countries worldwide. Since 2014, Gibson has consistently been ranked as one of the world's most highly cited authors in all of science by Thomson Reuters. In 2021, he was named one of the Fifty of the Most Influential Voices in Healthcare by Medika Life. His work has been cited over 170,000 times."Lexaria's drug delivery technology offers exciting new pathways towards improving pharmacokinetic drug performance that could unlock a new era of reduced drug waste and adverse side effects combined with enhanced efficacy," said Dr. Gibson. "I'm excited to pursue new and improved applications for this exciting technology.""Dr. Gibson has a wealth of knowledge and experience that will benefit Lexaria, particularly in the area of hypertension which remains an area of intense interest for Lexaria," said John Docherty, President. "On behalf of everyone at Lexaria, I welcome Dr. Gibson's contributions as our new Chief Medial Advisor and member of our scientific advisory board."As Chief Medical Advisor, Dr. Gibson will participate with other scientific and medical experts within Lexaria's newly-formed scientific advisory board in pursuing Lexaria's prioritized objectives in the fields of drug delivery optimization.Dr. Gibson has led phase 1-4 clinical trials, and cardiology megatrials of over 34,000 patients which eventuate in international approval of drugs like prasugrel, rivaroxaban, betrixaban and andexanet as well as devices such as one that alarms to alert a patient to heart attack. He founded WikiDoc.org and WikiPatient.org and is Editor-In-Chief of over 2,200 active contributors who have edited the content of over 100,000 chapters millions of times over the past 15 years. Gibson also founded www.clinicaltrialresults.org. Gibson serves as Chief Medical Correspondent for the American College of Cardiology. Gibson has over 435,000 followers on social media where he is a leading influencer, second only to Sanjay Gupta in some pollsAbout Lexaria Bioscience Corp. & DehydraTECHDehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral and topical formats. DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption and has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 46 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.CAUTION REGARDING FORWARD-LOOKING STATEMENTSThis press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.INVESTOR CONTACT:George Jurcic - Head of Investor Relations[email protected]Phone: 250-765-6424, ext 202SOURCE: Lexaria Bioscience Corp.

Executive Change

24 Nov 2023

·synapse.patsnap.com

What are COX inhibitors and how do you quickly get the latest development progress?

COX, or cyclooxygenase, is an enzyme that plays a crucial role in the human body's inflammatory response. It is responsible for the production of prostaglandins, which are hormone-like substances involved in various physiological processes. COX exists in two isoforms, COX-1 and COX-2. COX-1 is constitutively expressed and involved in maintaining normal bodily functions, such as protecting the stomach lining and regulating blood clotting. On the other hand, COX-2 is induced during inflammation and is primarily responsible for the production of prostaglandins that cause pain, fever, and swelling. Understanding the role of COX has led to the development of drugs called COX inhibitors, which are used to manage pain, inflammation, and other related conditions. COX inhibitors, can be categorized into two main types. The first are non-selective COX inhibitors, which can simultaneously inhibit both COX-1 and COX-2 enzymes, with Aspirin being a primary example. The second type involves selective COX-2 inhibitors, such as celecoxib, which was the first COX-2-specific inhibitor approved by the FDA for use in the treatment of familial adenomatous polyposis (FAP). There are two isozymes of cyclooxygenase, namely COX-1 and COX-2. COX-1 is an always-present enzyme in different tissues, including the stomach lining, platelets, and kidneys. On the other hand, COX-2 is an enzyme generally induced in the context of inflammation or tissue healing. Extensive research indicates that most tumors overexpress COX-2, while the expression of COX-1 shows no significant discrepancies between tumorous and normal tissues. Therefore, studies focusing on the role of cyclooxygenase in tumor progression primarily concern COX-2. The analysis of the target COX reveals a competitive landscape with several companies making progress in the development of COX inhibitors. GSK Plc, Viatris Inc., and Pfizer Inc. are among the companies growing fastest in this area. Pain, rheumatoid arthritis, and osteoarthritis are the most common indications for approved drugs. Small molecule drugs are progressing rapidly, indicating intense competition in the development of innovative drugs. China, the United States, and Japan are the leading countries/locations in COX inhibitors development. Overall, the target COX presents opportunities for further research and development, particularly in addressing pain management and rheumatic conditions. The mechanism of action of COX inhibitorsCOX inhibitors are a type of medication that inhibit the activity of cyclooxygenase (COX) enzymes. These enzymes play a crucial role in the production of prostaglandins, which are chemical messengers involved in inflammation, pain, and fever. COX inhibitors work by blocking the action of COX enzymes, thereby reducing the production of prostaglandins. From a biomedical perspective, COX inhibitors are commonly used in the treatment of pain, inflammation, and fever. They are widely prescribed for conditions such as arthritis, menstrual cramps, headaches, and post-operative pain. By reducing the production of prostaglandins, COX inhibitors help alleviate symptoms associated with these conditions. There are two main types of COX inhibitors: COX-1 inhibitors and COX-2 inhibitors. COX-1 inhibitors, such as aspirin, naproxen, and ibuprofen, inhibit both COX-1 and COX-2 enzymes. They are effective in relieving pain and inflammation but can also cause side effects such as stomach ulcers and bleeding. On the other hand, COX-2 inhibitors, such as celecoxib, selectively inhibit the COX-2 enzyme while sparing COX-1. This selective inhibition reduces the risk of stomach ulcers and bleeding associated with COX-1 inhibitors. COX-2 inhibitors are commonly used for long-term management of chronic conditions like osteoarthritis and rheumatoid arthritis. In summary, COX inhibitors are a class of medications that inhibit the activity of COX enzymes, reducing the production of prostaglandins. They are commonly used to treat pain, inflammation, and fever, with different types of COX inhibitors offering varying degrees of selectivity and side effects. List of COX InhibitorsThe currently marketed COX inhibitors include: Celecoxib/Tramadol HydrochlorideDiclofenac etalhyaluronateBupivacaine/MeloxicamAspirin/Vonoprazan FumarateBirch bark extractPrasugrel Hydrochloride/AspirinDiclofenac/LidocaineEsflurbiprofenAspirin ZincPolmacoxibFor more information, please click on the image below. What is the purpose of using COX inhibitors?COX inhibitors are commonly used for conditions such as angina, atrial fibrillation, arrhythmia, and myocardial infarction.For more information, please click on the image below to log in and search. How to obtain the latest development progress of COX inhibitors?In the Synapse database, you can keep abreast of the latest research and development advances of COX inhibitors anywhere and anytime, daily or weekly, through the "Set Alert" function. Click on the image below to embark on a brand new journey of drug discovery!

15 Nov 2021

·endpts.com

Eyeing an accelerated BLA, PhaseBio says its monoclonal antibody reversed the dangerous effects of AstraZeneca's blood thinner

A class of blood thinners called P2Y12 inhibitors has been used for the last couple decades to treat and prevent a range of cardiovascular conditions, including stroke and heart attack. But the antiplatelet drugs come with a risk of increased bleeding, which can prove fatal — especially for those who need urgent surgery and don’t have time to wean off their medication. PhaseBio is working on a solution for that. And on Monday, the company presented positive Phase III data that could pave the way for a mid-2022 BLA submission. The company’s lead drug bentracimab was shown to reverse the effects of AstraZeneca’s blood thinner Brilinta in an interim analysis of more than 100 patients who needed urgent surgery or an invasive procedure, PhaseBio announced at this year’s American Heart Association conference. Patients who took bentracimab in the pivotal REVERSE-IT trial saw a 135% reduction in platelet inhibition within 5 to 10 minutes of infusion (p<0.001) and saw those effects last over 24 hours, according to PhaseBio. The drug also met its co-primary endpoint, defined as good or excellent hemostasis within 24 hours of administration. Regulators previously told PhaseBio that an interim analysis from the first 100 patients in REVERSE-IT would be sufficient for an accelerated BLA submission, CEO Jonathan Mow told Endpoints News. “When we then looked at the Phase III data and saw that not only did we hit the VerifyNow, platelet biomarker endpoint, we also hit the clinical endpoint — albeit with a slightly larger number of patients, you know, 150 in total — but still, that’s a fantastic achievement for us. One that was not expected at this point in time,” he said. Bentracimab appeared safe, according to PhaseBio. And though 91% of patients reported a treatment-emergent side effect, the most common was pain associated with the surgical procedure. Eight experienced thrombotic events, though none of the cases were tied to bentracimab. “With no approved reversal agents for oral P2Y12 inhibitors, patients who are prescribed these medications to reduce the risk of cardiac events are at increased risk for spontaneous major bleeding events, and physicians are faced with a complex dilemma of balancing bleeding risk and thrombotic risk, should these patients require urgent surgery,” said Deepak Bhatt, executive director of interventional cardiovascular programs at Boston’s Brigham and Women’s Hospital, who presented the study at AHA. Doctors typically recommend patients stop taking P2Y12 inhibitors five to seven days before any type of surgical procedure. But while other P2Y12 inhibitors like Sanofi’s Plavix and Eli Lilly’s Effient aren’t reversible, Brilinta is. That’s because Plavix and Effient bind to the P2Y12 receptor permanently, so to regain functionality, you need to wait for platelet turnover. Brilinta, on the other hand, binds transiently and only has about a 15-minute residence time on the receptor. Bentracimab is a monoclonal antibody fragment that binds to Brilinta when it’s in that off state, and removes it from the platelet environment. “Essentially it just sequesters ticagrelor [Brilinta] from the platelet,” CMO John Lee told Endpoints. The Phase III readout comes just a couple weeks after PhaseBio reported positive topline results for a Phase IIb study evaluating bentracimab in healthy, older volunteers on Brilinta. Earlier results have also shown promise in treating younger volunteers. The news also bodes well for the Italian biotech Alfasigma, which back in June put down up to $245 million for the European rights to bentracimab. PhaseBio originally licensed the drug from MedImmune, the biologics arm of AstraZeneca, in 2017 for an upfront fee of $100,000, with $68 million in potential milestones. A little over a year later, the biotech rode that deal to an IPO with MedImmune owning 5% of the stock. And in 2019, bentracimab received breakthrough therapy designation from the FDA. While bentracimab would be the first antiplatelet reversal therapy for a P2Y12 inhibitor, it would not be the first to address the risk of bleeding in patients on blood thinners. Back in 2018, the FDA approved Portola Pharmaceuticals’ Andexxa as the first reversal agent for Factor Xa inhibitors, such as Janssen’s Xarelto and Bristol Myers Squibb and Pfizer’s Eliquis. PhaseBio is still recruiting patients with uncontrolled major or life-threatening bleeding for the REVERSE-IT trial, and aims to be fully-enrolled as soon as possible.

AntibodyBreakthrough TherapyAHAIPO

100 Deals associated with Prasugrel Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D05597	Prasugrel Hydrochloride	B01AC22	DB06209

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Brain Ischemia	Japan	Daiichi Sankyo Co., Ltd.	24 Dec 2021
Angina, Stable	Japan	Daiichi Sankyo Co., Ltd.	24 Mar 2014
Myocardial Infarction	Japan	Daiichi Sankyo Co., Ltd.	24 Mar 2014
Acute Coronary Syndrome	European Union	Vygoris Ltd.	24 Feb 2009
Acute Coronary Syndrome	Iceland	Vygoris Ltd.	24 Feb 2009
Acute Coronary Syndrome	Liechtenstein	Vygoris Ltd.	24 Feb 2009
Acute Coronary Syndrome	Norway	Vygoris Ltd.	24 Feb 2009
Angina, Unstable	European Union	Vygoris Ltd.	24 Feb 2009
Angina, Unstable	Iceland	Vygoris Ltd.	24 Feb 2009
Angina, Unstable	Liechtenstein	Vygoris Ltd.	24 Feb 2009
Angina, Unstable	Norway	Vygoris Ltd.	24 Feb 2009
Non-St Elevated Myocardial Infarction	European Union	Vygoris Ltd.	24 Feb 2009
Non-St Elevated Myocardial Infarction	Iceland	Vygoris Ltd.	24 Feb 2009
Non-St Elevated Myocardial Infarction	Liechtenstein	Vygoris Ltd.	24 Feb 2009
Non-St Elevated Myocardial Infarction	Norway	Vygoris Ltd.	24 Feb 2009
ST Elevation Myocardial Infarction	European Union	Vygoris Ltd.	24 Feb 2009
ST Elevation Myocardial Infarction	Iceland	Vygoris Ltd.	24 Feb 2009
ST Elevation Myocardial Infarction	Liechtenstein	Vygoris Ltd.	24 Feb 2009
ST Elevation Myocardial Infarction	Norway	Vygoris Ltd.	24 Feb 2009

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Anemia, Sickle Cell	Phase 3	United States	Daiichi Sankyo, Inc.	01 Apr 2013
Anemia, Sickle Cell	Phase 3	United States	Eli Lilly & Co.	01 Apr 2013
Anemia, Sickle Cell	Phase 3	Belgium	Daiichi Sankyo, Inc.	01 Apr 2013
Anemia, Sickle Cell	Phase 3	Belgium	Eli Lilly & Co.	01 Apr 2013
Anemia, Sickle Cell	Phase 3	Brazil	Daiichi Sankyo, Inc.	01 Apr 2013
Anemia, Sickle Cell	Phase 3	Brazil	Eli Lilly & Co.	01 Apr 2013
Anemia, Sickle Cell	Phase 3	Canada	Eli Lilly & Co.	01 Apr 2013
Anemia, Sickle Cell	Phase 3	Canada	Daiichi Sankyo, Inc.	01 Apr 2013
Anemia, Sickle Cell	Phase 3	Egypt	Eli Lilly & Co.	01 Apr 2013
Anemia, Sickle Cell	Phase 3	Egypt	Daiichi Sankyo, Inc.	01 Apr 2013

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ISAR-REACT5 (ESC2024)	Not Applicable	Acute Coronary Syndrome	-	Prasugrel	objnfxabup(eanmtdyvox) = bhaygnxsfw mvtuqngkay (wkrwfcvstt )	Positive	02 Sep 2024
				Ticagrelor	objnfxabup(eanmtdyvox) = soxzteisuf mvtuqngkay (wkrwfcvstt )
ESC2024	Not Applicable	Acute Coronary Syndrome	-	Clopidogrel	-	-	02 Sep 2024
				Prasugrel
ESC2024	Not Applicable	Non-St Elevated Myocardial Infarction	-	Prasugrel monotherapy (3.75mg/day)	lgmgzuathe(hiypgodzmi) = uxmramnjsy adzouxlvpa (ydudxskuqi ) View more	-	01 Sep 2024
ESC2024	Not Applicable	Coronary Disease	-	Prasugrel monotherapy	zvirjtukru(ltkhxnbxuq) = kelhutzbpv qjtnqfpkoz (clblthwoom )	-	01 Sep 2024
ESC2024	Not Applicable	Acute Coronary Syndrome	-	Standard dose ticagrelor	dgrzkeiypf(dymntxwwnr) = tlqeyokuna avwqenwecv (tuhbflzjeo ) View more	Positive	01 Sep 2024
				Reduced dose prasugrel	dgrzkeiypf(dymntxwwnr) = prnyeerddi avwqenwecv (tuhbflzjeo ) View more
ESC2024	Not Applicable	Myocardial Infarction	-	Prasugrel	ksdhbnkwzi(ccugcxocnc): HR = 0.67 (95% CI, 0.47 - 0.95) View more	-	30 Aug 2024
				Ticagrelor
ESC2024	Not Applicable	Coronary Disease	-	Clopidogrel	osbfnvyrix(fsdevfoamd) = dtuuyvopcp ksmxbyozqq (jdwamqxwbr )	-	30 Aug 2024
				Prasugrel or Ticagrelor	osbfnvyrix(fsdevfoamd) = wddqweilhm ksmxbyozqq (jdwamqxwbr )
NCT04668144 (SWAP-6, CTgov)	Phase 4	Acute Coronary Syndrome \| Coronary Artery Disease	359	Prasugrel (Prasugrel)	yalhuwqyus(ugpnyyxexp) = sgdunufzco zsmylaqade (nfblcbfzos, 31) View more	-	20 Mar 2024
				Cangrelor+Prasugrel (Prasugrel + Cangrelor)	yalhuwqyus(ugpnyyxexp) = bjfofbgova zsmylaqade (nfblcbfzos, 104) View more
NCT05223335 (CTgov)	Phase 4	Hemorrhage	98	Tricagrelor+Prasugrel (Genotype-Guided Therapy)	vkkowjzexi = dmmritmxji rrzmddyjpz (ckwtxnqsdw, ibyonipslt - qumzhikbdx) View more	-	21 Feb 2024
				Clopidogrel (Conventional Therapy)	vkkowjzexi = lppfddjfmt rrzmddyjpz (ckwtxnqsdw, zkycooqqap - ayqbjwfqiz) View more
NCT01944800 (ISAR-REACT 5, ESC2023)	Phase 4	Acute Coronary Syndrome	-	Ticagrelor	gbkgxmqfvc(akrrkukjvx): HR = 1.62 (95% CI, 1.09 - 2.41)	Negative	27 Aug 2023
				Prasugrel

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis