What is apixaban studying for intracerebral hemorrhage and atrial fibrillation?

Apixaban is being studied to see if it can better prevent stroke or death compared to aspirin in patients who recently had an intracerebral hemorrhage and have atrial fibrillation. The goal is to understand if apixaban improves survival and functional recovery. This research is sponsored by Yale University through a national stroke network.

Who may be eligible for this intracerebral hemorrhage clinical trial?

Adults aged 18 years or older with a recent intracerebral hemorrhage confirmed by brain imaging and a diagnosis of non-valvular atrial fibrillation may be eligible. Both men and women can participate, but pregnant or breastfeeding individuals are excluded. Those requiring other anticoagulants or with certain bleeding risks may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this intracerebral hemorrhage clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel expenses to and from study visits may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID03907046

Anticoagulation in Intracerebral Hemorrhage Survivors for Stroke Prevention and Recovery

Led by Yale University · Updated on 2026-05-08

700

Participants Needed

187

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the use of apixaban compared to aspirin to prevent stroke or death in patients who have had a recent intracerebral hemorrhage ICH and also have atrial fibrillation AF. This phase III randomized, double-blinded trial aims to determine if apixaban is superior in preventing any type of stroke or death, as well as if it leads to better functional recovery measured by the modified Rankin Scale. The study will enroll 700 patients and follow them for 12 to 36 months to assess these outcomes. Participants will be randomly assigned to receive either apixaban or aspirin. Apixaban dosing is typically 5 mg twice daily, with a reduced dose of 2.5 mg twice daily for those meeting specific criteria such as older age, lower body weight, or certain medication use. Aspirin is given once daily at a dose of 81 mg. The study includes a treatment period after recent ICH, with careful monitoring for safety and efficacy. During the study, participants will undergo regular assessments including evaluation of stroke occurrence, death, and changes in functional status using the modified Rankin Scale. Safety and adherence will be monitored throughout the follow-up period, which ranges from 12 months up to 3 years. The research team will collect data to understand the benefits and risks of apixaban versus aspirin in this patient population.

CONDITIONS

Brief Title

Anticoagulation in ICH Survivors for Stroke Prevention and Recovery

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age at least 18 years
Intracerebral hemorrhage (including primary intraventricular hemorrhage) confirmed by brain CT or MRI
Can be randomized within 14-180 days after ICH onset
Non-valvular atrial fibrillation or atrial flutter documented by ECG or physician history
Signed informed consent by patient or legally authorized representative
For females of reproductive potential: use of highly effective contraception

You will not qualify if you...

Hemorrhagic transformation of brain infarction or hemorrhage into a tumor
History of earlier intracerebral hemorrhage within 12 months before index event
Active infective endocarditis
Clear indication for anticoagulant or antiplatelet drugs for other medical conditions
Previous or planned left atrial appendage closure
Clinically significant bleeding diathesis
Serum creatinine 2.5 mg/dL or higher
Active hepatitis or significant liver insufficiency (Child-Pugh B or C)
Chronic anemia (hemoglobin <8 g/dL) or thrombocytopenia (<100 x 10^9/L) as judged by investigator
Pregnant or breastfeeding
Known allergy to aspirin or apixaban
Participation in another competing clinical trial
Condition precluding safe or active participation
Persistent uncontrolled systolic blood pressure of 180 mm Hg or higher
Intracerebral hemorrhage caused by unsecured arteriovenous malformation (AVM)

Research Team

Kevin N Sheth, MD

Hooman Kamel, MD

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here