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Antiplatelet agent
Clopidogrel for Silent Stroke (ECISBI Trial)
Phase 4
Recruiting
Led By Calin Ioan Prodan, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
ECISBI Trial Summary
This trial will test whether the drug clopidogrel can decrease the rate of new silent brain infarctions, which are linked to an increased risk for subsequent stroke and cognitive decline.
Who is the study for?
This trial is for individuals who've had a stroke or transient ischemic attack (TIA) within the last month, have initial MRI scans available, and are not on antiplatelet therapy. They must be willing to participate for two years and need secondary prevention with antiplatelet therapy as decided by their doctor. People with dementia, recent anticoagulant use, allergy to clopidogrel, certain bleeding conditions or severe kidney disease cannot join.Check my eligibility
What is being tested?
The study tests if Clopidogrel can reduce new silent brain infarctions in patients at risk of strokes due to high coated-platelet levels. It compares the effectiveness of Clopidogrel against Aspirin treatment over a period of 24 months.See study design
What are the potential side effects?
Clopidogrel may cause bleeding problems, allergic reactions, headaches, dizziness, gastrointestinal discomfort or liver enzyme changes. Aspirin might lead to stomach upset/pain, heartburn or increased risk of bleeding.
ECISBI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
new silent brain infarctions
Secondary outcome measures
cognitive impairment
ECISBI Trial Design
2Treatment groups
Experimental Treatment
Group I: ClopidogrelExperimental Treatment1 Intervention
After randomization, patients will receive clopidogrel mg daily for the duration of the study. The VA Research Pharmacy will dispense similar looking pills (using a "dummy pill") with Arm 2 to ensure the double-blind nature of the intervention. Clopidogrel is FDA approved for secondary prevention of stroke. Patients will be followed for 24 months with repeat brain MRI scans obtained at 24 months.
Group II: AspirinExperimental Treatment1 Intervention
After randomization, patients will receive aspirin daily for the duration of the study. The VA Research Pharmacy will dispense similar looking pills (using a "dummy pill") with Arm 1 to ensure the double-blind nature of the intervention. Aspirin is FDA approved for secondary prevention of stroke. Patients will be followed for 24 months with repeat brain MRI scans obtained at 24 months.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,621 Previous Clinical Trials
3,323,349 Total Patients Enrolled
Calin Ioan Prodan, MDPrincipal InvestigatorOklahoma City VA Medical Center, Oklahoma City, OK
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My symptoms started more than 90 days ago.My symptoms started less than 90 days ago.I started blood thinners or clot-dissolving drugs before my blood was drawn.My doctor has prescribed a specific antiplatelet dose or dual therapy for me.My kidneys are in the final stage of chronic kidney disease.I have been diagnosed with a stroke or a mini-stroke.I am not on antiplatelet therapy.My doctor has prescribed antiplatelet therapy for prevention.I have not had any brain bleeding or bleeding disorders.
Research Study Groups:
This trial has the following groups:- Group 1: Clopidogrel
- Group 2: Aspirin
Awards:
This trial has 3 awards, including:- 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.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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