Clevidipine

Intracerebral hemorrhage (ICH) is associated with adverse functional outcomes and elevated mortality, driven by hematoma size and expansion. Timely blood pressure (BP) management may help mitigate hematoma growth. We aimed to assess the effects of clevidipine, an intravenously administered calcium‐channel blocker, on hematoma volume and functional outcomes compared with standard antihypertensive therapy in hypertensive ICH patients.

We performed a prospective cohort study with a historical control group assessing serial hematoma volume measurements and clinical outcomes in acute hypertensive ICH patients treated with intravenous clevidipine (2023–2025) compared with standard antihypertensive therapy using labetalol, clonidine and/or diuretics (2020–2022; prior to clevidipine availability).

Sixty‐four patients (cases:25; controls:39) were included. There was no difference in demographic characteristics and admission National Institutes of Health Stroke Scale (NIHSS) scores between cases and controls. Clevidipine administration resulted in effective BP control (< 140/90 mmHg) within 3.5 ± 3.2 h from treatment onset, with no hematoma expansion (0.0 vs. 7.7% in controls; p  = 0.172) and significant ICH volume reduction on 24‐h follow‐up brain‐CT (14.7% vs. 4.5% in controls; p  = 0.023). A trend toward greater improvement in NIHSS scores during hospitalization and numerically lower 3‐month mortality rates were observed in clevidipine group. No serious adverse events were reported in the clevidipine‐treated patients. In multivariable linear regression models adjusting for potential confounders, clevidipine‐use was independently associated with greater ICH‐volume reduction ( β  = −0.16, 95% CI: −0.30, −0.02, p  = 0.024).

The present study highlights that clevidipine represents a safe and effective option in terms of acute BP management among patients with hypertensive ICH and may limit hematoma expansion.

Limited studies have provided guidance on the optimal systolic blood pressure (SBP) after mechanical thrombectomy (MT) in acute ischemic stroke patients. In the Clevidipine Infusion for Blood Pressure Management After Successful Revascularization in Acute Ischemic Stroke (CLEVER) trial, our aim was to study the safety and efficacy of intensive SBP control with a Clevidipine infusion as the first-line agent.

The CLEVER trial was an investigator-initiated, single-center, open-label, randomized, controlled trial. Patients were randomized 1:1 to a SBP goal after successful MT (mTICI 2c or greater) of either 90-120mmHg (Intensive BP Management) or 90-160mmHg (Standard BP Management). The primary outcomes were time to target blood pressure and incidence of any hemorrhagic conversion at 24 hours.

Between October 2021 and December 2023, 80 eligible patients were enrolled, 40 each into the intensive BP and the standard BP management cohorts. Overall, 72% of all BP measurements in the intensive BP management group were within the target range, compared to 93% in the standard BP management group (p&lt;0.001). The median time from the initiation of Clevidipine infusion until reaching the target SBP was significantly shorter in the standard BP management group, 10 minutes [IQR 5.0-45.0] versus 20 IQR 12.5-42.5] (95%CI:5.0-20.0, p=0.002). The incidence of hemorrhagic transformation per core lab was not significantly different in the intensive BP management group (32.5%) and the standard BP management group (35.0%); adjusted OR (0.93 [95%CI, 0.30-2.85]; p=0.89).

In the randomised CLEVER trial, intensive BP control using clevidipine after MT failed to reduce the rate of haemorrhagic conversion or sICH and resulted in a numerically lower rate of good clinical outcome compared to standard BP control. Clevidipine was well tolerated in both cohorts and demonstrated a similar safety profile. Larger studies are needed to understand the efficacy and safety of clevidipine for BP control and the optimal BP threshold after MT.