Phase IV, Non-comparative, Open Label, Multicenter, 28-Week Switching Study of Prasugrel Maintenance Dose From Clopidogrel in Patients With Acute Coronary Syndrome (ACS) Who Underwent a Percutaneous Coronary Intervention (PCI) in Taiwan

This Phase IV, multicenter trial is designed to assess the efficacy of prasugrel in preventing the formation of blood clots in Taiwanese patients with ACS who have been treated with PCI.

Start Date16 Oct 2018

Sponsor / Collaborator

Daiichi Sankyo Taiwan Ltd.

NCT03368196 / CompletedPhase 1

Phase 1, Multicenter, Open-label Study of DS-8201a to Assess Safety and Pharmacokinetics in Subjects With HER2-Positive Advanced and/or Refractory Gastric, Gastroesophageal Junction Adenocarcinoma, or Breast Cancer

HER2-positive cancer is a cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2). HER2 promotes the growth of certain cancer cells. This study will test DS-8201a (trastuzumab deruxtecan), a HER2-targeted antibody and topoisomerase I inhibitor conjugate.
The safety and tolerability profile of DS-8201a will be assessed in Chinese patients with certain types of stomach and breast cancer that test positive for HER2. It also will test how DS-8201a moves within the body (pharmacokinetics).

Start Date02 Apr 2018

Sponsor / Collaborator

Daiichi Sankyo Taiwan Ltd.

[+1]

NCT01053026 / CompletedNot ApplicableIIT

Evaluation of Vascular Function, Effects of Exercise Training and Angiotensin Receptor II Antagonist in Patients With Type II Diabetes and Hypertension by Using Near-infrared Spectroscopy, Rapid Laser Doppler Blood Flow Imaging and Circulating Biomarkers

The aims of this clinical trial are to assess the impacts on vascular function tests and circulating biomarkers of a short-term (12-week) low-to-median intensity exercise training or ARBs treatment in patients with DM and hypertension.

Start Date01 Dec 2009

Sponsor / Collaborator

National Taiwan University Hospital

[+1]

100 Clinical Results associated with Daiichi Sankyo Taiwan Ltd.

0 Patents (Medical) associated with Daiichi Sankyo Taiwan Ltd.

Literatures (Medical) associated with Daiichi Sankyo Taiwan Ltd.

01 Nov 2022·Acta Cardiologica Sinica

A HANC Risk Stratification Score for Antiplatelet Therapy Optimization with Low-Dose Prasugrel in Taiwanese Acute Coronary Syndrome Patients from the Switch Study.

Article

Author: Su, Cheng-Huang ; Kuo, Feng-Yu ; Lee, Hsin-Fu ; Lu, Tse-Min ; Cheng, Li-Chung ; Chu, Pao-Hsien ; Lee, Wen-Lieng ; Lin, Wei-Shiang ; Liu, Ping-Yen ; Yang, Wei-Chen ; Yin, Wei-Hsian ; Wang, Yi-Chih ; Su, Chieh-Shou ; Tung, Ying-Chang ; Tsukiyama, Shuji ; Lin, Yen-Hung ; Lo, Ping-Han

BackgroundA significant proportion of acute coronary syndrome (ACS) patients experience high on-treatment platelet reactivity (HPR) on clopidogrel-based dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI).ObjectivesThis study assessed key independent risk factors associated with significant HPR risk on clopidogrel, but not prasugrel, in the Switch Study cohort of 200 Taiwanese ACS patients who switched from clopidogrel to low-dose prasugrel for maintenance DAPT after PCI.MethodsUnivariate analysis and stepwise multivariate logistic regression analysis were conducted to identify key independent risk factors for HPR on clopidogrel, but not prasugrel.ResultsA HANC [H: low hemoglobin (< 13 g/dL for men and < 12 g/dL for women); A: age ≥ 65 years; N: non-ST elevation myocardial infarction; C: chronic kidney disease as defined by estimated glomerular filtration rate < 60 mL/min] risk stratification score was developed, and demonstrated optimal sensitivity and specificity at a cutoff score of ≥ 2. The HANC score compared favorably against the recently validated ABCD score in the full Switch Study cohort (n = 200), and the ABCD-GENE score in a genotyped cohort (n = 102).ConclusionsThe HANC score may serve to alert clinicians to patients at potentially higher HPR risk on clopidogrel, but not prasugrel. Further research to validate this score and assess its correlation with clinical outcomes is warranted.

01 Sep 2022·Journal of the Formosan Medical AssociationQ3 · MEDICINE

Effect of CYP2C19 status on platelet reactivity in Taiwanese acute coronary syndrome patients switching to prasugrel from clopidogrel: Switch Study

Q3 · MEDICINE

ArticleOA

Author: Lan, Wei-Ren ; Yin, Wei-Hsian ; Lo, Ping-Han ; Su, Cheng-Huang ; Lin, Wei-Shiang ; Lu, Tse-Min ; Wang, Yi-Chih ; Yang, Wei-Chen ; Cheng, Li-Chung ; Chu, Pao-Hsien ; Lee, Cheng-Han ; Huang, Chien-Lung ; Lee, Wen-Lieng ; Liu, Ping-Yen ; Tsukiyama, Shuji ; Kuo, Feng-Yu

BACKGROUND/PURPOSEPharmacogenetics is a potential driver of the "East Asian paradox," in which East Asian acute coronary syndrome (ACS) patients receiving dual antiplatelet therapy (DAPT) with clopidogrel following percutaneous coronary intervention (PCI) demonstrate higher levels of platelet reactivity on treatment than Western patients, yet have lower ischemic risk and higher bleeding risk at comparable doses. However, the impact of pharmacogenetics, particularly regarding CYP2C19 genotype, on the pharmacodynamics of P2Y12 inhibitors has not been extensively studied in Taiwanese ACS patients as yet.METHODSCYP2C19 genotyping and pharmacogenetic analysis was conducted on 102 subjects from the Switch Study, a multicenter, single-arm, open-label intervention study that examined the effects on platelet activity and clinical outcomes of switching from clopidogrel (75 mg daily) to low-dose prasugrel (3.75 mg daily) for maintenance DAPT after PCI in 203 Taiwanese ACS patients.RESULTSGenotyping results revealed that 43.1% were CYP2C19 extensive metabolizers (EM), while 56.9% were reduced metabolizers (RM). After switching to prasugrel, mean P2Y12 reaction units (PRU) values were significantly reduced in both EM and RM populations, while the proportion of high on-treatment platelet reactivity (HPR) patients significantly declined in RM patients. No increase in bleeding risk after switching was observed during follow-up. Multivariate analysis indicated that for RM patients, low estimated glomerular filtration rate (eGFR) and low hemoglobin were associated with greater HPR risk on clopidogrel, but not after switching to prasugrel.CONCLUSIONSwitching to low-dose prasugrel from clopidogrel reduced mean PRU levels and proportion of HPR patients, with more significant reduction in RM patients.

01 Apr 2022·Cardiovascular Intervention and Therapeutics

Prasugrel switching from clopidogrel after percutaneous coronary intervention for acute coronary syndrome in Taiwanese patients: an analysis of safety and efficacy

Article

Author: Nikolajsen, Christian ; Lee, Wen-Lieng ; Lu, Tse-Min ; Lo, Ping-Han ; Lee, Cheng-Han ; Chu, Pao-Hsien ; Su, Cheng-Huang ; Tsukiyama, Shuji ; Yang, Wei-Chen ; Lin, Wei-Shiang ; Lan, Wei-Ren ; Yin, Wei-Hsian ; Kuo, Feng-Yu ; Liu, Ping-Yen ; Wang, Yi-Chih ; Cheng, Li-Chung ; Huang, Chien-Lung ; Rafael, Virginia

AbstractThe recommended maintenance dose of prasugrel for East Asian populations (i.e., Japanese and Taiwanese) is 3.75 mg as part of dual antiplatelet therapy (DAPT) for the prevention of recurrent ischemia and stent thrombosis in acute coronary syndrome (ACS). This modified dosage regimen has been established in studies conducted in Japan; however, the efficacy and safety of switching from clopidogrel to prasugrel DAPT among Taiwanese patients remain to be explored. In this phase IV, multicenter, single-arm, open-label study, we evaluated the 4-week pharmacodynamic response, and the 48-week safety outcomes of prasugrel 3.75 mg after a switch from clopidogrel in Taiwanese ACS patients. A total of 203 prasugrel-naïve ACS patients (over 90% male) who had received post-PCI clopidogrel DAPT for at least 2 weeks were enrolled from ten medical centers in Taiwan and subsequently switched to prasugrel 3.75 mg DAPT. Four weeks after the switch, P2Y12 reaction unit (PRU) values were significantly decreased in the total cohort (mean − 18.2 ± 48.1; 95% confidence interval − 24.9 to − 11.5,p < 0.001), and there was an overall consistent antiplatelet response in the treated subjects. The proportion of patients with high on-treatment platelet reactivity (HPR; PRU > 208) dropped from 23.5 to 10% (p < 0.001). Female sex was associated with a greater PRU reduction with prasugrel, whereas HPR at baseline, age ≥ 65 years, and body mass index ≥ 25 best predicted HPR at Week 4. Throughout the 48-week treatment with prasugrel, the incidences of MACE (1.0%) and TIMI major bleeding (2.0%) were rather low, accompanying an acceptable safety profile of TIMI minor (6.4%) and non-major, non-minor clinically relevant bleeding (3.0%). Overall, switching to the maintenance dose of prasugrel (3.75 mg) was observed to be effective and well tolerated among post-PCI ACS patients in Taiwan. Clinical Trial Registration Number: NCT03672097.

100 Deals associated with Daiichi Sankyo Taiwan Ltd.

100 Translational Medicine associated with Daiichi Sankyo Taiwan Ltd.

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