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

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal 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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

new silent brain infarctions

Secondary study objectives

cognitive impairment

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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

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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