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

ProMedica Health System80 enrolled

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. 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Stroke, Acute Blood Pressure Mechanical Thrombectomy

Interventions

ClevidipineDRUG

Blood pressure management with Clevidipine

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

ProMedica Toledo Hospital

Toledo, Ohio, United States

Outcomes

Primary Outcomes

Primary Efficacy Endpoint (Drug-related)

Time to target blood pressure

Time frame: Time from drug initiation to target blood pressure, up to 24 hours after study drug adminstration

Primary Safety Endpoint (Disease-related)

Incidence of any hemorrhagic conversion at 24 hours

Time frame: 24 hours from the time of treatment with Clevidipine

Secondary Outcomes

Drug-related

The efficacy of Clevidipine in maintaining BP within range using area under the curve (AUC) analysis of BP excursions beyond predetermined upper and lower limits using statistical models from the ECLIPSE Trials.

Time frame: Up to 24 hours after study drug adminstration

Drug-related, Rate of hypotension requiring intervention

Rate of hypotension requiring intervention

Time frame: Up to 24 hours after study drug adminstration

Drug-related, Rate of hypotension and severe hypertension

Rate of hypotension and severe hypertension

Time frame: Up to 24 hours after study drug adminstration

Disease-related, Incidence of symptomatic intracerebral hemorrhage

Incidence of symptomatic intracerebral hemorrhage (sICH), defined as any intracranial hemorrhage and neurologic worsening of at least 4 points on the National Institute of Health Stroke Scale (NIHSS), according to the 2nd European-Australasian Acute Stroke Study (ECASS II) criteria within 24 hours of randomization

Time frame: Within 24 hours of randomization

Disease-related, Delayed ICH after 24 hours

Data from ClinicalTrials.gov

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