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

• Sponsor: ProMedica Health System (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05175547
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke, Acute; Blood Pressure; Mechanical Thrombectomy	Drug: Clevidipine	Phase 3

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.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.
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Clevidipine Infusion for Blood Pressure Management After Successful Revascularization in Acute Ischemic Stroke (CLEVER)
• Actual Study Start Date: Nov 1, 2021
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Nov 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Primary Efficacy Endpoint (Drug-related) [Time from drug initiation to target blood pressure, up to 24 hours after study drug adminstration]

   Time to target blood pressure

2. Primary Safety Endpoint (Disease-related) [24 hours from the time of treatment with Clevidipine]

   Incidence of any hemorrhagic conversion at 24 hours

Secondary Outcome Measures

1. Drug-related [Up to 24 hours after study drug adminstration]

   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.

2. Drug-related, Rate of hypotension requiring intervention [Up to 24 hours after study drug adminstration]

   Rate of hypotension requiring intervention

3. Drug-related, Rate of hypotension and severe hypertension [Up to 24 hours after study drug adminstration]

   Rate of hypotension and severe hypertension

4. Disease-related, Incidence of symptomatic intracerebral hemorrhage [Within 24 hours of randomization]

   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

5. Disease-related, Delayed ICH after 24 hours [Within 24 hours of randomization]

   Delayed ICH after 24 hours

6. Disease-related, Incidence of acute kidney injury [From drug adminstration to 90 days post-randomization]

   Incidence of acute kidney injury

7. Disease-related, [90 days after randomization]

   Mortality rate at 90 days

8. Disease-related, Length of hospital stay [Day 6 (+/- 1 day) post-randomization or discharge (whichever sooner)]

   Length of hospital stay

9. Disease-related, Use of additional hypertensive agents [Up to 24 hours after study drug adminstration]

   Use of additional hypertensive agents

10. Disease-related, Onset of atrial fibrillation or cardiovascular events [Up to 24 hours after study drug adminstration]

    Onset of atrial fibrillation or cardiovascular events

11. Disease-related, mRS 0-2 or return to baseline at 90 days [90 days post-randomization]

    mRS 0-2 or return to baseline at 90 days

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 1. Age 18 or older
• 1. Acute hypertension (systolic blood pressure of greater than 140 mmHg) at recanalization
• 1. 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
• 1. Success revascularization score of mTICI 2c or higher after mechanical thrombectomy
• 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 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 this study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ProMeedica Toledo Hospital	Toledo	Ohio	United States	43606

Sponsors and Collaborators

• ProMedica Health System

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ProMedica Health System
• ClinicalTrials.gov Identifier: NCT05175547
• Other Study ID Numbers: CLEVER
• First Posted: Jan 3, 2022
• Last Update Posted: Jan 3, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Stroke; Ischemic Stroke; Clevidipine

Study Results

No Results Posted as of Jan 3, 2022