Clinical trial NCT05175547: Clevidipine Infusion for Blood Pressure Management After Successful Revascularization in Acute Ischemic Stroke
Official title: Clevidipine Infusion for Blood Pressure Management After Successful Revascularization in Acute Ischemic Stroke (CLEVER)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stroke, Acute
Blood Pressure
Mechanical Thrombectomy
Lead sponsor: ProMedica Health System
Sponsor class: OTHER
First posted: 2022-01-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Primary Efficacy Endpoint (Drug-related)
timeFrame: Time from drug initiation to target blood pressure, up to 24 hours after study drug adminstration
measure: Primary Safety Endpoint (Disease-related)
timeFrame: 24 hours from the time of treatment with Clevidipine
Secondary outcomes:
measure: Drug-related
timeFrame: Up to 24 hours after study drug adminstration
measure: Drug-related, Rate of hypotension requiring intervention
timeFrame: Up to 24 hours after study drug adminstration
measure: Drug-related, Rate of hypotension and severe hypertension
timeFrame: Up to 24 hours after study drug adminstration
measure: Disease-related, Incidence of symptomatic intracerebral hemorrhage
timeFrame: Within 24 hours of randomization
measure: Disease-related, Delayed ICH after 24 hours
timeFrame: Within 24 hours of randomization
measure: Disease-related, Incidence of acute kidney injury
timeFrame: From drug adminstration to 90 days post-randomization
measure: Disease-related,
timeFrame: 90 days after randomization
measure: Disease-related, Length of hospital stay
timeFrame: Day 6 (+/- 1 day) post-randomization or discharge (whichever sooner)
measure: Disease-related, Use of additional hypertensive agents
timeFrame: Up to 24 hours after study drug adminstration
measure: Disease-related, Onset of atrial fibrillation or cardiovascular events
timeFrame: Up to 24 hours after study drug adminstration
measure: Disease-related, mRS 0-2 or return to baseline at 90 days
timeFrame: 90 days post-randomization
Other outcomes:
Locations:
city: Toledo
country: United States
facility: ProMedica Toledo Hospital
state: Ohio
Study officials:
affiliation: ProMedica Health System
name: Mouhammad Jumaa, MD
role: PRINCIPAL_INVESTIGATOR
References: