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

NCT05175547 | Completed Phase 3 FDA Drug

• 1 other identifier: CLEVER
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke, Acute; Blood Pressure; Mechanical Thrombectomy

Outcome Measures

Primary Outcomes (2)

• Primary Efficacy Endpoint (Drug-related)

  Time to target blood pressure

  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

  24 hours from the time of treatment with Clevidipine

Secondary Outcomes (11)

• Drug-related

  Up to 24 hours after study drug adminstration

• Drug-related, Rate of hypotension requiring intervention

  Up to 24 hours after study drug adminstration

• Drug-related, Rate of hypotension and severe hypertension

  Up to 24 hours after study drug adminstration

• Disease-related, Incidence of symptomatic intracerebral hemorrhage

  Within 24 hours of randomization

• Disease-related, Delayed ICH after 24 hours

  Within 24 hours of randomization

Study Arms (2)

Intensive blood pressure management group

ACTIVE COMPARATOR

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

Drug: Clevidipine

Standard blood pressure management group

ACTIVE COMPARATOR

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

Drug: Clevidipine

Interventions

Clevidipine DRUG

Blood pressure management with Clevidipine

Intensive blood pressure management group; Standard blood pressure management group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age 18 or older
• \. Acute hypertension (systolic blood pressure of greater than 140 mmHg) at recanalization
• \. 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
• \. Success revascularization score of mTICI 2c or higher after mechanical thrombectomy
• \. ASPECTS score of greater than 6
• \. Premorbid mRS 0-4
• \. Signed informed consent within 30 minutes from end of MT procedure.

You may not qualify if:

• \. Presence of any hemorrhage and/or ASPECT score ≤6 on baseline head CT scan
• \. Pregnant or lactating
• \. Acute traumatic brain injury
• \. Patient on active dialysis
• \. Intracranial neoplasm
• \. Acute or recent STEMI in the last 30 days
• \. Severe arrhythmias, unstable cardiac function
• \. Any terminal medical condition with life expectancy less than 6 months
• \. Concurrent enrollment in another trial that could confound the results of this study

Sponsors & Collaborators

• ProMedica Health System: lead

Study Sites (1)

ProMedica Toledo Hospital

Toledo, Ohio, 43606, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

clevidipine

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mouhammad Jumaa, MD

  ProMedica Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: January 3, 2022
• Study Start: October 30, 2021
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)