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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-30

Study Completion Date

2024-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stroke, Acute Blood Pressure Mechanical Thrombectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Eligible patients will be randomized 1:1 to a systolic blood pressure goal after successful MT (mTICI 2c or greater) of either: 90-120 or 90-160mmHg.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intensive blood pressure management group

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

Group Type ACTIVE_COMPARATOR

Clevidipine

Intervention Type DRUG

Blood pressure management with Clevidipine

Standard blood pressure management group

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

Group Type ACTIVE_COMPARATOR

Clevidipine

Intervention Type DRUG

Blood pressure management with Clevidipine

Interventions

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Clevidipine

Blood pressure management with Clevidipine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No