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

ProMedica Health System

Status and phase: Completed; Phase 3

Conditions: Stroke, Acute; Mechanical Thrombectomy; Blood Pressure

Treatments: Drug: Clevidipine

Study type: Interventional

Funder types: Other

Identifiers

NCT05175547

CLEVER

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Intensive blood pressure management group

Active Comparator group

Description:

Target blood pressure of 90-120mmHg (Intensive BP management group)

Treatment:

Drug: Clevidipine

Standard blood pressure management group

Active Comparator group

Description:

Target blood pressure of 90-160mmHg (Standard BP management group)

Treatment:

Drug: Clevidipine