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

Last updated: January 6, 2025
Sponsor: ProMedica Health System
Overall Status: Completed

Phase

3

Condition

Stroke

Cardiac Ischemia

Blood Clots

Treatment

Clevidipine

Clinical Study ID

NCT05175547
CLEVER
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18 or older
  1. Acute hypertension (systolic blood pressure of greater than 140 mmHg) atrecanalization
  1. Anterior circulation ischemic stroke symptoms and confirmed occlusion (ICA, M1,or M2) on angiogram with mechanical thrombectomy initiated within 24 hourssince last known well
  1. Success revascularization score of mTICI 2c or higher after mechanicalthrombectomy
  1. ASPECTS score of greater than 6
  1. Premorbid mRS 0-4
  1. Signed informed consent within 30 minutes from end of MT procedure.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: Clevidipine
Phase: 3
Study Start date:
October 30, 2021
Estimated Completion Date:
February 28, 2024

Study 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.

Connect with a study center

  • ProMedica Toledo Hospital

    Toledo, Ohio 43606
    United States

    Site Not Available

  • ProMeedica Toledo Hospital

    Toledo, Ohio 43606
    United States

    Active - Recruiting

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