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Anticoagulant

Apixaban vs Aspirin for Stroke Prevention in Atrial Fibrillation After Brain Bleed (ASPIRE Trial)

Phase 3

Recruiting

Led By Hooman Kamel, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

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

Must have

Non-valvular AF (defined as atrial fibrillation or atrial flutter), documented by electrocardiography or a physician-confirmed history of prior AF

Age at least 18 years

Must not have

Previous or planned left atrial appendage closure

Active infective endocarditis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Pivotal Trial

Summary

This trial is testing whether apixaban is better than aspirin at preventing strokes or death in patients who have recently had a bleed in the brain and also have atrial fibrillation.

Who is the study for?

This trial is for adults who've had a recent brain bleed (ICH) and atrial fibrillation but no ICH in the past year, no severe kidney or liver issues, not pregnant/breastfeeding, and without certain blood conditions. They must be able to start the trial within 14-180 days after their ICH.

What is being tested?

The study aims to see if apixaban is better than aspirin at preventing strokes or death in people with atrial fibrillation who recently had an ICH. It also looks at whether apixaban leads to better recovery outcomes using a disability scale.

What are the potential side effects?

Apixaban may cause bleeding complications, allergic reactions, liver enzyme changes, and nausea. Aspirin can lead to gastrointestinal bleeding, allergic reactions, ringing in ears at high doses, and increased bruising.

Eligibility Criteria

Inclusion Criteria

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

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I have a type of irregular heartbeat not caused by a heart valve issue.

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I am 18 years old or older.

Exclusion Criteria

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

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I have had or will have a procedure to close off a part of my heart.

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I have an ongoing heart infection.

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I need medication for blood clots or after a heart stent procedure.

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I have severe liver problems.

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I have a brain bleed caused by an unsecured AVM.

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I have a bleeding disorder that affects my daily life.

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I have long-term low blood counts, either anemia or low platelets.

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My stroke turned into bleeding in the brain or a tumor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Stroke or death

Secondary study objectives

Modified Rankin Scale (mRS) score

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: ApixabanActive Control1 Intervention

Apixaban dosing will be 5 mg tablet in morning and 5 mg tablet in evening. A reduced dose of 2.5 mg tablet in morning and 2.5 mg tablet in evening will be used if: (1) ≥2 of the following are present: age ≥80 years, body weight ≤60 kg, or serum creatinine 1.5-2.4 mg/dL, or (2) Patient is taking a strong CYP3A4/pGP inhibitor (e.g., ketoconazole, itraconazole, ritonavir, or clarithromycin).

Group II: AspirinPlacebo Group1 Intervention

Aspirin dose will be 81 mg tablet once daily.

0 / 10Eligibility criteria met