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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 month
Awards & highlights
No Placebo-Only Group
Pivotal Trial

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 days
Treatment ~ 12 months
Follow Up ~1 month
This trial's timeline: 3 days for screening, 12 months for treatment, and 1 month 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

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

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

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,409 Previous Clinical Trials
765,540 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,385 Previous Clinical Trials
651,005 Total Patients Enrolled
1 Trials studying Intracranial Arteriosclerosis
159 Patients Enrolled for Intracranial Arteriosclerosis
University of CincinnatiOTHER
439 Previous Clinical Trials
637,065 Total Patients Enrolled
Medical University of South CarolinaOTHER
979 Previous Clinical Trials
7,399,311 Total Patients Enrolled
2 Trials studying Intracranial Arteriosclerosis
602 Patients Enrolled for Intracranial Arteriosclerosis
Janssen Scientific Affairs, LLCIndustry Sponsor
164 Previous Clinical Trials
578,116 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,427 Previous Clinical Trials
289,162,928 Total Patients Enrolled
Brian Hoh, MD, MBAPrincipal InvestigatorUniversity of Florida
Brian L. Hoh, MD, MBAPrincipal InvestigatorUniversity of Florida
Marc I. Chimowitz, MBChBPrincipal InvestigatorMedical University of South Carolina

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
~1000 spots leftby May 2028
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