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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
Must not have
Intracranial neoplasm
Acute or recent STEMI in the last 30 days
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days post-randomization
Awards & highlights
No Placebo-Only Group
Pivotal 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.
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.
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.

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.
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I am 18 years old or older.
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a brain tumor.
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I had a severe heart attack in the last 30 days.
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I have recently suffered a traumatic brain injury.
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I do not have severe heart rhythm problems or unstable heart function.
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I am currently receiving dialysis treatment.
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I have bleeding in my brain or a low stroke severity score.
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My doctor expects I have less than 6 months to live due to my condition.

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
High Blood Pressure Research Study Groups: Standard blood pressure management group, Intensive blood pressure management group
High Blood Pressure 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
~2 spots leftby Jan 2025
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