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

Blood Pressure Clinical Trial

— CLEVER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05175547
• Other study ID #: CLEVER
• Status: Recruiting
• Phase: Phase 3
• Start date: November 1, 2021
• Est. completion date: November 1, 2025

Study information

• Verified date: April 2023
• Source: ProMedica Health System
• Contact: Mouhammad Jumaa, MD
• Phone: 419-291-8027
• Email: Mouhammad.JumaaMD[@]ProMedica.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Ischemic Stroke
• Mechanical Thrombectomy
• Stroke
• Stroke, Acute

Intervention

Drug:
• Clevidipine
Blood pressure management with Clevidipine

Locations

Country	Name	City	State
United States	ProMeedica Toledo Hospital	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
ProMedica Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Primary Safety Endpoint (Disease-related)	Incidence of any hemorrhagic conversion at 24 hours	24 hours from the time of treatment with Clevidipine
Secondary	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
Secondary	Drug-related, Rate of hypotension requiring intervention	Rate of hypotension requiring intervention	Up to 24 hours after study drug adminstration
Secondary	Drug-related, Rate of hypotension and severe hypertension	Rate of hypotension and severe hypertension	Up to 24 hours after study drug adminstration
Secondary	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
Secondary	Disease-related, Delayed ICH after 24 hours	Delayed ICH after 24 hours	Within 24 hours of randomization
Secondary	Disease-related, Incidence of acute kidney injury	Incidence of acute kidney injury	From drug adminstration to 90 days post-randomization
Secondary	Disease-related,	Mortality rate at 90 days	90 days after randomization
Secondary	Disease-related, Length of hospital stay	Length of hospital stay	Day 6 (+/- 1 day) post-randomization or discharge (whichever sooner)
Secondary	Disease-related, Use of additional hypertensive agents	Use of additional hypertensive agents	Up to 24 hours after study drug adminstration
Secondary	Disease-related, Onset of atrial fibrillation or cardiovascular events	Onset of atrial fibrillation or cardiovascular events	Up to 24 hours after study drug adminstration
Secondary	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