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

• Status: Recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ProMedica Health System
• Treatments: Clevidipine

Criteria

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