Back to resultsClevidipine Infusion for Blood Pressure Management After Successful Revascularization in Acute Ischemic Stroke (CLEVER)
Primary Purpose
Stroke, Acute, Blood Pressure, Mechanical Thrombectomy
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Clevidipine
Sponsored by
About this trial
This is an interventional treatment trial for Stroke, Acute
Eligibility Criteria
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
Sites / Locations
- ProMeedica Toledo HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Intensive blood pressure management group
Standard blood pressure management group
Arm Description
Target blood pressure of 90-120mmHg (Intensive BP management group)
Target blood pressure of 90-160mmHg (Standard BP management group)
Outcomes
Primary Outcome Measures
Primary Efficacy Endpoint (Drug-related)
Time to target blood pressure
Primary Safety Endpoint (Disease-related)
Incidence of any hemorrhagic conversion at 24 hours
Secondary Outcome Measures
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.
Drug-related, Rate of hypotension requiring intervention
Rate of hypotension requiring intervention
Drug-related, Rate of hypotension and severe hypertension
Rate of hypotension and severe hypertension
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
Disease-related, Delayed ICH after 24 hours
Delayed ICH after 24 hours
Disease-related, Incidence of acute kidney injury
Incidence of acute kidney injury
Disease-related,
Mortality rate at 90 days
Disease-related, Length of hospital stay
Length of hospital stay
Disease-related, Use of additional hypertensive agents
Use of additional hypertensive agents
Disease-related, Onset of atrial fibrillation or cardiovascular events
Onset of atrial fibrillation or cardiovascular events
Disease-related, mRS 0-2 or return to baseline at 90 days
mRS 0-2 or return to baseline at 90 days
Full Information
NCT ID
NCT05175547
First Posted
November 23, 2021
Last Updated
April 19, 2023
Sponsor
ProMedica Health System
1. Study Identification
Unique Protocol Identification Number
NCT05175547
Brief Title
Clevidipine Infusion for Blood Pressure Management After Successful Revascularization in Acute Ischemic Stroke
Acronym
CLEVER
Official Title
Clevidipine Infusion for Blood Pressure Management After Successful Revascularization in Acute Ischemic Stroke (CLEVER)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
November 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ProMedica Health System
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute, Blood Pressure, Mechanical Thrombectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intensive blood pressure management group
Arm Type
Active Comparator
Arm Description
Target blood pressure of 90-120mmHg (Intensive BP management group)
Arm Title
Standard blood pressure management group
Arm Type
Active Comparator
Arm Description
Target blood pressure of 90-160mmHg (Standard BP management group)
Intervention Type
Drug
Intervention Name(s)
Clevidipine
Intervention Description
Blood pressure management with Clevidipine
Primary Outcome Measure Information:
Title
Primary Efficacy Endpoint (Drug-related)
Description
Time to target blood pressure
Time Frame
Time from drug initiation to target blood pressure, up to 24 hours after study drug adminstration
Title
Primary Safety Endpoint (Disease-related)
Description
Incidence of any hemorrhagic conversion at 24 hours
Time Frame
24 hours from the time of treatment with Clevidipine
Secondary Outcome Measure Information:
Title
Drug-related
Description
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
Title
Drug-related, Rate of hypotension requiring intervention
Description
Rate of hypotension requiring intervention
Time Frame
Up to 24 hours after study drug adminstration
Title
Drug-related, Rate of hypotension and severe hypertension
Description
Rate of hypotension and severe hypertension
Time Frame
Up to 24 hours after study drug adminstration
Title
Disease-related, Incidence of symptomatic intracerebral hemorrhage
Description
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
Title
Disease-related, Delayed ICH after 24 hours
Description
Delayed ICH after 24 hours
Time Frame
Within 24 hours of randomization
Title
Disease-related, Incidence of acute kidney injury
Description
Incidence of acute kidney injury
Time Frame
From drug adminstration to 90 days post-randomization
Title
Disease-related,
Description
Mortality rate at 90 days
Time Frame
90 days after randomization
Title
Disease-related, Length of hospital stay
Description
Length of hospital stay
Time Frame
Day 6 (+/- 1 day) post-randomization or discharge (whichever sooner)
Title
Disease-related, Use of additional hypertensive agents
Description
Use of additional hypertensive agents
Time Frame
Up to 24 hours after study drug adminstration
Title
Disease-related, Onset of atrial fibrillation or cardiovascular events
Description
Onset of atrial fibrillation or cardiovascular events
Time Frame
Up to 24 hours after study drug adminstration
Title
Disease-related, mRS 0-2 or return to baseline at 90 days
Description
mRS 0-2 or return to baseline at 90 days
Time Frame
90 days post-randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mouhammad Jumaa, MD
Phone
419-291-8027
Email
Mouhammad.JumaaMD@ProMedica.org
First Name & Middle Initial & Last Name or Official Title & Degree
Alicia Castonguay, PhD
Phone
419-291-1895
Email
alicia.castonguay@utoledo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mouhammad Jumaa, MD
Organizational Affiliation
ProMedica Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
ProMeedica Toledo Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mouhammad Jumaa, MD
Phone
419-291-8027
Email
Mouhammad.JumaaMD@ProMedica.org
First Name & Middle Initial & Last Name & Degree
Alicia Castonguay, PhD
Phone
419-291-1895
Email
alicia.castonguay@utoledo.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clevidipine Infusion for Blood Pressure Management After Successful Revascularization in Acute Ischemic Stroke
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