Purpose of this Study
We are doing this study to compare 2 different options for preventing strokes for people who have atrial fibrillation. We want to find out if apixaban or aspirin is the better choice to help prevent future strokes for patients with atrial fibrillation and who had a recent brain hemorrhage.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Had an intracerebral hemorrhage (including primary intraventricular hemorrhage) within the past 180 days
- Are diagnosed with non-valvular AF (defined as atrial fibrillation or atrial flutter)
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, we will schedule you for a "baseline" visit that you can do in-person or over the phone or computer. If we determine that you are eligible to continue in the study, you will get a random assignment (like a coin flip) to 1 of 2 study groups. Depending on your assignment, you will either:
- Take an 81 mg dose of aspirin every day; OR
- Take a 5 or 2.5 mg dose of apixaban twice per day (your dose will depend on your age, weight, and kidney function)
- Assessing for any strokes or adverse events since your last visit
- Assessing how well you are taking your study medications
- Assessing your physical health
- Assessing what other medications you are taking
- Assessing your blood pressure
- Providing you with a re-supply of the study medications
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors
for Stroke Prevention and Recovery
for Stroke Prevention and Recovery
Principal Investigator
Dylan
Ryan
Protocol Number
PRO00116346
NCT ID
NCT03907046
Phase
III
Enrollment Status
Pending Open to Enrollment