Overview
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.
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.
Eligibility
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