Apixaban vs Aspirin for Stroke Prevention in Atrial Fibrillation After Brain Bleed
(ASPIRE Trial)
Trial Summary
What is the purpose of this trial?
Primary Aim: To determine if apixaban is superior to aspirin for prevention of the composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in patients with recent ICH and atrial fibrillation (AF). Secondary Aim: To determine if apixaban, compared with aspirin, results in better functional outcomes as measured by the modified Rankin Scale.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have a clear need for certain blood thinners or antiplatelet drugs like aspirin or clopidogrel.
What data supports the effectiveness of the drug Apixaban for stroke prevention in atrial fibrillation?
Research shows that Apixaban is more effective than aspirin in reducing the risk of stroke in patients with atrial fibrillation, without significantly increasing the risk of major bleeding. It has also been shown to be superior to warfarin in reducing stroke and systemic embolism, with a lower risk of bleeding.12345
Is Apixaban safe for use in humans?
Apixaban (Eliquis) is generally well tolerated in humans, with studies showing a lower risk of major bleeding compared to some other treatments for blood clots. It is used for conditions like venous thromboembolism (VTE) and atrial fibrillation, and safety measures include educational materials to minimize bleeding risks.13678
How does the drug apixaban differ from other treatments for preventing stroke in atrial fibrillation after a brain bleed?
Apixaban is unique because it is an oral medication that directly inhibits factor Xa, a key protein in the blood clotting process, and it does not require routine blood monitoring like some other anticoagulants. It offers a balance of reducing stroke risk with a comparable bleeding risk to aspirin, making it a suitable option for patients who cannot use traditional blood thinners like warfarin.13679
Research Team
Kevin N Sheth, MD
Principal Investigator
Yale University
Hooman Kamel, MD
Principal Investigator
Weill Medical College of Cornell University
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to receive either apixaban or aspirin for stroke prevention and recovery
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Apixaban
- Aspirin
Apixaban is already approved in European Union, United States for the following indications:
- Deep vein thrombosis
- Pulmonary embolism
- Nonvalvular atrial fibrillation
- Deep vein thrombosis
- Pulmonary embolism
- Nonvalvular atrial fibrillation
- Stroke prevention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator