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Clevidipine for Blood Pressure Control After Stroke (CLEVER Trial)

Phase 3
Recruiting
Led By Mouhammad Jumaa, MD
Research Sponsored by ProMedica Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Signed informed consent within 30 minutes from end of MT procedure
Age 18 or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days post-randomization
Awards & highlights

CLEVER Trial Summary

This trial is testing a new blood pressure medication to see if it is safe and effective in people who are having a mechanical thrombectomy to remove a blood clot.

Who is the study for?
This trial is for adults over 18 who've had a successful mechanical thrombectomy for an ischemic stroke in the brain's anterior circulation within the last day. They must have high blood pressure after the procedure, a decent chance of recovery, and give consent quickly post-procedure. Pregnant women, those with recent severe heart issues or brain injuries, terminal conditions, or hemorrhages on their CT scans can't join.Check my eligibility
What is being tested?
The CLEVER Study is testing how safe and effective Clevidipine is at controlling high blood pressure in patients who've just undergone a mechanical thrombectomy to treat an acute ischemic stroke. Participants are randomly assigned to receive this medication as part of standard care.See study design
What are the potential side effects?
Clevidipine may cause side effects like headache, nausea, rapid heartbeat or palpitations; it might also lead to low blood pressure if not carefully monitored during infusion.

CLEVER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I signed the consent form within 30 minutes after the MT procedure.
Select...
I am 18 years old or older.
Select...
I had a stroke with a blocked artery in my brain and received a clot removal procedure within 24 hours.
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I was mostly independent in daily activities before my current illness.

CLEVER Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days post-randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days post-randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Efficacy Endpoint (Drug-related)
Disease
Secondary outcome measures
Disease-related
Disease-related, Delayed ICH after 24 hours
Disease-related, Incidence of acute kidney injury
+8 more

CLEVER Trial Design

2Treatment groups
Active Control
Group I: Standard blood pressure management groupActive Control1 Intervention
Target blood pressure of 90-160mmHg (Standard BP management group)
Group II: Intensive blood pressure management groupActive Control1 Intervention
Target blood pressure of 90-120mmHg (Intensive BP management group)

Find a Location

Who is running the clinical trial?

ProMedica Health SystemLead Sponsor
13 Previous Clinical Trials
680 Total Patients Enrolled
Mouhammad Jumaa, MDPrincipal InvestigatorProMedica Health System

Media Library

Standard blood pressure management group Clinical Trial Eligibility Overview. Trial Name: NCT05175547 — Phase 3
Stroke Research Study Groups: Standard blood pressure management group, Intensive blood pressure management group
Stroke Clinical Trial 2023: Standard blood pressure management group Highlights & Side Effects. Trial Name: NCT05175547 — Phase 3
Standard blood pressure management group 2023 Treatment Timeline for Medical Study. Trial Name: NCT05175547 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other research groups who have looked into similar methods of managing blood pressure?

"At this time, there is 1 active clinical trial being conducted to explore the efficacy of Standard blood pressure management group. This research is being conducted at 1 location, with 1 trial in Phase 3."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
What site did they apply to?
ProMeedica Toledo Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Clevidipine Infusion for Blood Pressure Management After Successful Revascularization in Acute Ischemic Stroke
2021. "Clevidipine Infusion for Blood Pressure Management After Successful Revascularization in Acute Ischemic Stroke". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05175547.
All > Blood Pressure
~17 spots leftby Jan 2025
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