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Antiplatelet

Anti-Coagulant + Anti-Platelet Therapy for Stroke Prevention (CAPTIVA Trial)

Phase 3

Recruiting

Led By Brian Hoh, MD, MBA

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Modified Rankin score of ≤ 4

Age 30-80 years, inclusive, at time of consent

Must not have

Previous treatment of target lesion with a stent, angioplasty, or other mechanical device, including mechanical thrombectomy for the qualifying stroke, or plan to perform one of these procedures

Plan to perform concomitant angioplasty or stenting of an extracranial vessel tandem to the symptomatic intracranial stenosis

Timeline

Screening 3 days

Treatment 12 months

Follow Up 1 months

Awards & highlights

Summary

This trial is testing whether two drugs are better than one at preventing strokes.

Who is the study for?

Adults aged 30-80 with recent symptoms or signs of a stroke due to 70-99% blockage in a major brain artery, who can swallow pills and have certain heart or blood vessel conditions. Excluded are those with previous stent treatments for the lesion, bleeding disorders, severe liver issues, uncontrolled high blood pressure, substance abuse, certain heart conditions that could cause clots, planned major surgeries within 90 days after joining the trial, severe neurological deficits preventing independence, life expectancy under one year due to other illnesses.

What is being tested?

The study is testing if adding rivaroxaban or ticagrelor (or both) to aspirin is better than just clopidogrel plus aspirin at reducing the risk of another stroke or death from vascular causes within a year. Participants will be randomly assigned to one of these treatment combinations.

What are the potential side effects?

Possible side effects include increased risk of bleeding (gastrointestinal bleeds), bruising easily due to reduced clotting ability from anti-coagulant and anti-platelet drugs. There may also be digestive discomfort like stomach pain or indigestion and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can walk and take care of myself despite some disability.

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I am between 30 and 80 years old.

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I have been treating my diabetes with insulin for 15 years or more.

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I have a history of heart or artery procedures due to blocked arteries.

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I have a narrowed artery due to plaque buildup confirmed by imaging tests.

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I have plaque in my aortic arch confirmed by imaging tests.

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I can walk and take care of myself despite some disability.

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I am between 30 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had or plan to have a procedure like stenting for my stroke.

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I am scheduled for a procedure to open narrowed arteries in my head and neck.

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I have a brain tumor (not meningioma) or a brain blood vessel problem.

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I have not had clot-dissolving drugs in the last 24 hours.

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My neurological symptoms have worsened in the last 24 hours.

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I have had a brain bleed in the past.

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I have a specific blood vessel condition in my brain not caused by common diseases.

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I have a heart condition that could cause blood clots.

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I am allergic to aspirin, rivaroxaban, clopidogrel, or ticagrelor.

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I do not have severe bleeding, liver issues, uncontrolled high blood pressure, or major kidney problems.

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I haven't had major surgery in the last 30 days and don't plan any in the next 90 days.

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I cannot live on my own due to severe neurological issues.

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I do not have any health conditions that could shorten my life to under a year.

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I am not taking, nor required to take, strong medication that affects liver enzyme activity during this study.

Timeline

Screening ~ 3 days1 visit

Treatment ~ 12 months6 visits

Follow Up ~ 1 months6 visits

Screening ~ 3 days

Treatment ~ 12 months

Follow Up ~1 months

This trial's timeline: 3 days for screening, 12 months for treatment, and 1 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

Number of participants with ischemic stroke, intracerebral hemorrhage or vascular death

Number of participants with parenchymal ICH or non-ICH major hemorrhage

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Experimental Arm: Ticagrelor and AspirinExperimental Treatment2 Interventions

Ticagrelor (180mg loading dose, then 90mg twice daily) and aspirin (81mg daily)

Group II: Experimental Arm: Rivaroxaban and AspirinExperimental Treatment2 Interventions

Rivaroxaban (2.5mg twice daily) and aspirin (81mg daily)

Group III: Standard of Care Arm: Clopidogrel and AspirinActive Control2 Interventions

Clopidogrel (600mg loading dose, then 75mg once daily) and aspirin (81mg daily)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ticagrelor + Aspirin

2013

Completed Phase 4

~20

0 / 22Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor

1,380 Previous Clinical Trials

760,712 Total Patients Enrolled

National Institute of Neurological Disorders and Stroke (NINDS)NIH

1,362 Previous Clinical Trials

649,067 Total Patients Enrolled

University of CincinnatiOTHER

433 Previous Clinical Trials

634,720 Total Patients Enrolled

Media Library

Clopidogrel (Antiplatelet) Clinical Trial Eligibility Overview. Trial Name: NCT05047172 — Phase 3

Intracranial Arteriosclerosis Research Study Groups: Experimental Arm: Ticagrelor and Aspirin, Standard of Care Arm: Clopidogrel and Aspirin, Experimental Arm: Rivaroxaban and Aspirin

Intracranial Arteriosclerosis Clinical Trial 2023: Clopidogrel Highlights & Side Effects. Trial Name: NCT05047172 — Phase 3

Clopidogrel (Antiplatelet) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05047172 — Phase 3

Intracranial Arteriosclerosis Patient Testimony for trial: Trial Name: NCT05047172 — Phase 3

~932 spots leftby Apr 2027

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