MRI for Stroke

(CAPTIVA-MRI Trial)

Recruiting at 14 trial locations

Overseen By Amy Sulken

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must be taking: Aspirin, Ticagrelor, Clopidogrel, Rivaroxaban

Disqualifiers: Pacemaker, Gadolinium allergy, Kidney disease, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to improve treatment for individuals who have experienced a stroke due to significant narrowing (70-99%) of the brain's blood vessels. Researchers aim to determine if different blood-thinning treatments, such as aspirin with ticagrelor, clopidogrel, or rivaroxaban, are more effective for these patients. Participants also undergo MRI scans to identify those who might not respond well to these treatments. Suitable candidates have had a mild stroke within the last 30 days due to this type of vessel narrowing and can safely undergo MRI scans. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that taking aspirin with medications like ticagrelor or clopidogrel can be safe for individuals with certain artery diseases. One study found that combining aspirin with these drugs did not lead to more serious brain bleeding or increase the risk of death, indicating that the combination is generally well-tolerated.

For rivaroxaban, another medication under study, results are mixed. A study found that rivaroxaban alone caused more major bleeding than aspirin alone. However, researchers continue to investigate whether combining rivaroxaban with aspirin is safe and effective for stroke prevention.

Overall, these treatments have shown promise in past studies, but like any medication, they carry risks. Patients should know that safety is closely monitored in these trials to ensure the best outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for intracranial atherosclerotic stenosis (ICAS) because they combine anti-platelet and anti-coagulation therapies in novel ways. While standard care usually involves drugs like aspirin or clopidogrel alone, this approach explores combinations including ticagrelor, clopidogrel, or rivaroxaban with aspirin. These combinations aim to enhance the effectiveness of preventing further strokes by addressing blood clot formation more comprehensively. By targeting multiple pathways involved in clotting, these treatments could offer superior protection compared to traditional single-agent therapies.

What evidence suggests that this trial's treatments could be effective for ICAS?

This trial will evaluate different medication combinations for patients with stroke attributed to 70-99% intracranial atherosclerotic stenosis (ICAS). Research has shown that taking aspirin with ticagrelor or clopidogrel can lower the risk of complications after a stroke caused by severe narrowing of brain arteries. One study found that this combination worked better than aspirin alone in reducing the chance of another stroke. Another study found that adding rivaroxaban to aspirin therapy can lower stroke risk by 2.3% per year in patients with similar conditions. However, using rivaroxaban alone, without aspirin, did not improve outcomes and led to more major bleeding. These findings suggest that combining medications can be more effective in preventing further strokes in patients with narrowed brain arteries. Participants in this trial will receive aspirin plus ticagrelor, clopidogrel, or rivaroxaban to assess their effectiveness in this context. ^{1 3 4 6 7}

Who Is on the Research Team?

Adam de Havenon, MD, MS

Principal Investigator

Yale University

David Liebeskind, MD

Principal Investigator

University of California, Los Angeles

Sepideh Amin-Hanjani, MD

Principal Investigator

University Hospitals

Rano Chatterjee, MD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

Inclusion Criteria

Enrollment in the CAPTIVA trial: nondisabling symptomatic ischemic infarct stroke within 30 days secondary to 70-99% stenosis of the intracranial ICA, MCA, BA or VA

Ability to obtain baseline study MRI within 14 days of CAPTIVA enrollmen

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive aspirin plus ticagrelor, clopidogrel, or rivaroxaban

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MRI

How Is the Trial Designed?

Group I: CAPTIVA-MRI Group Experimental Treatment 1 Intervention

CAPTIVA patients with stroke attributed to 70-99% intracranial atherosclerotic stenosis (ICAS) to aspirin plus ticagrelor, clopidogrel, or rivaroxaban.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39781748/

Combination Antithrombotic Therapy for Reduction of ... The composite efficacy outcome was less frequent in the combination arm (15.7%) compared with the aspirin arm (24.0%), with a hazard ratio of ...

2. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.123.043633

Optimal Medical Management of Atherosclerotic ... The use of rivaroxaban 2.5 mg BID with aspirin resulted in an absolute stroke reduction of 2.3% per year for patients with previously reported ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05700266

Anticoagulation Using Rivaroxaban on Top of Aspirin in ... The primary goal of the clinical trial is to test the effect of oral rivaroxaban plus aspirin in patients with recent stroke/ transient ischemic attack ...

4. nature.com nature.com/articles/s41598-023-51013-3

Combined use of anticoagulant and antiplatelet on ... Recent studies suggested that low-dose rivaroxaban combined with aspirin could improve cardiovascular outcomes among patients with coronary ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa1709118

Rivaroxaban with or without Aspirin in Stable ... Rivaroxaban (5 mg twice daily) alone did not result in better cardiovascular outcomes than aspirin alone and resulted in more major bleeding events.

6. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.124.047715

Combination Antithrombotic Therapy for Reduction of ... In patients with systemic atherosclerosis, a significant reduction of stroke risk with no increase in intracranial or fatal hemorrhage was seen ...

7. ahajournals.org ahajournals.org/doi/10.1161/JAHA.123.031611

Ticagrelor Versus Clopidogrel in Minor Stroke or Transient ... Patients without ICAS received a significantly greater benefit from ticagrelor–aspirin than clopidogrel–aspirin after minor ischemic stroke or transient ...