Clevidipine Infusion for Blood Pressure Management After Successful Revascularization in Acute Ischemic Stroke

Phase 3

Completed

• Conditions: Stroke, Acute; Blood Pressure; Mechanical Thrombectomy
• Interventions: Drug: Clevidipine

• Registration Number: NCT05175547
• Lead Sponsor: ProMedica Health System

Brief Summary

The CLEVER Study is a prospective, 2-arm, randomized, single-center pilot study to assess the safety and efficacy of intensive blood pressure control using Clevidipine (on-label use) in AIS patients undergoing standard of care mechanical thrombectomy (MT) within 24-hours of symptoms onset.

Detailed Description

The CLEVER Study is a prospective, 2-arm, randomized, single-center pilot study to assess the safety and efficacy of intensive blood pressure control using Clevidipine (on-label use) in AIS patients undergoing standard of care mechanical thrombectomy (MT) within 24-hours of symptoms onset. Eligible patients will be randomized 1:1 to a systolic blood pressure goal after successful MT (mTICI 2c or greater) of either: 90-120mmHg (Intensive BP management group) or 90-160mmHg (Standard BP management group). Patients enrolled into the study will be followed and assessed for up to 3 months.

Study Timeline

• Study Start: 2021-10-30
• Study First Submitted: 2021-11-23
• Study First Submitted QC: 2021-12-14
• Study First Posted: 2022-01-03
• Primary Completion: 2024-02-28
• Study Completion: 2024-02-28
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 1. Age 18 or older
• 2. Acute hypertension (systolic blood pressure of greater than 140 mmHg) at recanalization
• 3. Anterior circulation ischemic stroke symptoms and confirmed occlusion (ICA, M1, or M2) on angiogram with mechanical thrombectomy initiated within 24 hours since last known well
• 4. Success revascularization score of mTICI 2c or higher after mechanical thrombectomy
• 5. ASPECTS score of greater than 6
• 6. Premorbid mRS 0-4
• 7. Signed informed consent within 30 minutes from end of MT procedure.

Exclusion Criteria

• 1. Presence of any hemorrhage and/or ASPECT score ≤6 on baseline head CT scan
• 2. Pregnant or lactating
• 3. Acute traumatic brain injury
• 4. Patient on active dialysis
• 5. Intracranial neoplasm
• 6. Acute or recent STEMI in the last 30 days
• 7. Severe arrhythmias, unstable cardiac function
• 8. Any terminal medical condition with life expectancy less than 6 months
• 9. Concurrent enrollment in another trial that could confound the results of this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive blood pressure management group	Clevidipine	Target blood pressure of 90-120mmHg (Intensive BP management group)
Standard blood pressure management group	Clevidipine	Target blood pressure of 90-160mmHg (Standard BP management group)

Primary Outcome Measures

Name	Time	Method
Primary Efficacy Endpoint (Drug-related)	Time from drug initiation to target blood pressure, up to 24 hours after study drug adminstration	Time to target blood pressure
Primary Safety Endpoint (Disease-related)	24 hours from the time of treatment with Clevidipine	Incidence of any hemorrhagic conversion at 24 hours

Secondary Outcome Measures

Name	Time	Method
Drug-related, Rate of hypotension and severe hypertension	Up to 24 hours after study drug adminstration	Rate of hypotension and severe hypertension
Drug-related	Up to 24 hours after study drug adminstration	The efficacy of Clevidipine in maintaining BP within range using area under the curve (AUC) analysis of BP excursions beyond predetermined upper and lower limits using statistical models from the ECLIPSE Trials.
Disease-related, Incidence of acute kidney injury	From drug adminstration to 90 days post-randomization	Incidence of acute kidney injury
Disease-related,	90 days after randomization	Mortality rate at 90 days
Disease-related, Use of additional hypertensive agents	Up to 24 hours after study drug adminstration	Use of additional hypertensive agents
Disease-related, Onset of atrial fibrillation or cardiovascular events	Up to 24 hours after study drug adminstration	Onset of atrial fibrillation or cardiovascular events
Disease-related, Incidence of symptomatic intracerebral hemorrhage	Within 24 hours of randomization	Incidence of symptomatic intracerebral hemorrhage (sICH), defined as any intracranial hemorrhage and neurologic worsening of at least 4 points on the National Institute of Health Stroke Scale (NIHSS), according to the 2nd European-Australasian Acute Stroke Study (ECASS II) criteria within 24 hours of randomization
Disease-related, Delayed ICH after 24 hours	Within 24 hours of randomization	Delayed ICH after 24 hours
Drug-related, Rate of hypotension requiring intervention	Up to 24 hours after study drug adminstration	Rate of hypotension requiring intervention
Disease-related, Length of hospital stay	Day 6 (+/- 1 day) post-randomization or discharge (whichever sooner)	Length of hospital stay
Disease-related, mRS 0-2 or return to baseline at 90 days	90 days post-randomization	mRS 0-2 or return to baseline at 90 days

Trial Locations

Locations (1)

ProMedica Toledo Hospital; 🇺🇸 Toledo, Ohio, United States