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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Blood Pressure; Stroke, Acute; Mechanical Thrombectomy
• Intervention / Treatment: Drug: Clevidipine

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Mouhammad Jumaa, MD; Phone Number: 419-291-8027; Email: Mouhammad.JumaaMD@ProMedica.org
• Study Contact Backup: Name: Alicia Castonguay, PhD; Phone Number: 419-291-1895; Email: alicia.castonguay@utoledo.edu

Study Locations

• United States
  • Ohio
    • Toledo, Ohio, United States, 43606
      • Recruiting
      • ProMeedica Toledo Hospital
      • Contact: Mouhammad Jumaa, MD; Phone Number: 419-291-8027; Email: Mouhammad.JumaaMD@ProMedica.org
      • Contact: Alicia Castonguay, PhD; Phone Number: 419-291-1895; Email: alicia.castonguay@utoledo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intensive blood pressure management group; Target blood pressure of 90-120mmHg (Intensive BP management group)	Drug: Clevidipine; Blood pressure management with Clevidipine
Active Comparator: Standard blood pressure management group; Target blood pressure of 90-160mmHg (Standard BP management group)	Drug: Clevidipine; Blood pressure management with Clevidipine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 24 hours after study drug adminstration
Drug-related, Rate of hypotension requiring intervention	Rate of hypotension requiring intervention	Up to 24 hours after study drug adminstration
Drug-related, Rate of hypotension and severe hypertension	Rate of hypotension and severe hypertension	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	Within 24 hours of randomization
Disease-related, Delayed ICH after 24 hours	Delayed ICH after 24 hours	Within 24 hours of randomization
Disease-related, Incidence of acute kidney injury	Incidence of acute kidney injury	From drug adminstration to 90 days post-randomization
Disease-related,	Mortality rate at 90 days	90 days after randomization
Disease-related, Length of hospital stay	Length of hospital stay	Day 6 (+/- 1 day) post-randomization or discharge (whichever sooner)
Disease-related, Use of additional hypertensive agents	Use of additional hypertensive agents	Up to 24 hours after study drug adminstration
Disease-related, Onset of atrial fibrillation or cardiovascular events	Onset of atrial fibrillation or cardiovascular events	Up to 24 hours after study drug adminstration
Disease-related, mRS 0-2 or return to baseline at 90 days	mRS 0-2 or return to baseline at 90 days	90 days post-randomization

Collaborators and Investigators

• Sponsor: ProMedica Health System
• Investigators: Principal Investigator: Mouhammad Jumaa, MD, ProMedica Health System

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): November 1, 2025

Study Registration Dates

• First Submitted: November 23, 2021
• First Submitted That Met QC Criteria: December 14, 2021
• First Posted (Actual): January 3, 2022

Study Record Updates

• Last Update Posted (Actual): April 20, 2023
• Last Update Submitted That Met QC Criteria: April 19, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Clevidipine
• Other Study ID Numbers: CLEVER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No