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

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

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.

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.

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