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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

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

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,610 Previous Clinical Trials

3,305,032 Total Patients Enrolled

Calin Ioan Prodan, MDPrincipal InvestigatorOklahoma City VA Medical Center, Oklahoma City, OK

Media Library

Aspirin (Antiplatelet agent) Clinical Trial Eligibility Overview. Trial Name: NCT04698031 — Phase 4

Silent Stroke Research Study Groups: Clopidogrel, Aspirin

Silent Stroke Clinical Trial 2023: Aspirin Highlights & Side Effects. Trial Name: NCT04698031 — Phase 4

Aspirin (Antiplatelet agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04698031 — Phase 4

Frequently Asked Questions

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

Who is eligible for enrollment in this research study?

"To qualify for the trial, potential participants must have silent brain infarction and be between 21 and 90 years old. Enrollment is open to a maximum of 152 individuals."

Answered by AI

Are participants currently being recruited for this experiment?

"Affirmative. The clinical trial is still actively recruiting, as evidenced by the information available on clinicaltrials.gov. This study was first posted on March 30th 2022 and last updated April 1st 2022; 152 patients need to be enrolled across one medical facility."

Answered by AI

Is the age qualification for this trial limited to individuals over twenty years of age?

"This medical study is reserved for patients between the ages of 21 and 90. Those who are under 18 have 26 other studies to choose from, while those above 65 have 519 options."

Answered by AI

How many participants is the study currently accommodating?

"Affirmative. According to clinicaltrials.gov, this experiment is actively searching for participants. It was first advertised on March 30th 2022 and finalized its details on April 1st 2022 with the goal of recruiting 152 patients from one research centre."

Answered by AI

What medical conditions have been effectively treated with Clopidogrel?

"Clopidogrel therapy is a commonly prescribed treatment for stroke, recurrent. It also has proven efficacy in treating peripheral arterial disease (PAD), myocardial infarction mortality, and back pain."

Answered by AI

Is this clinical trial pioneering a new kind of treatment?

"Initially studied in 2005 by Abbott, Clopidogrel treatment has since undergone 15480 trials and achieved Phase 4 drug approval. Currently, 191 clinical studies are underway across 1410 cities and 57 countries worldwide regarding the effectiveness of this medication."

Answered by AI