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Anticoagulant
Apixaban vs Aspirin for Stroke Prevention in Atrial Fibrillation After Brain Bleed (ASPIRE Trial)
Phase 3
Recruiting
Led By Kevin N Sheth, 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
ASPIRE 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.Check my eligibility
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.See study design
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.
ASPIRE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a type of irregular heartbeat not caused by a heart valve issue.
Select...
I am 18 years old or older.
ASPIRE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Stroke or death
Secondary outcome measures
Modified Rankin Scale (mRS) score
ASPIRE 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.
Find a Location
Who is running the clinical trial?
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,340 Previous Clinical Trials
648,664 Total Patients Enrolled
2 Trials studying Atrial Fibrillation
783 Patients Enrolled for Atrial Fibrillation
Yale UniversityLead Sponsor
1,848 Previous Clinical Trials
2,737,118 Total Patients Enrolled
5 Trials studying Atrial Fibrillation
804 Patients Enrolled for Atrial Fibrillation
Kevin N Sheth, MDPrincipal InvestigatorYale School of Medicine
1 Previous Clinical Trials
88 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a type of irregular heartbeat not caused by a heart valve issue.I have had or will have a procedure to close off a part of my heart.I have an ongoing heart infection.I need medication for blood clots or after a heart stent procedure.I have severe liver problems.Your systolic blood pressure is consistently very high (≥180 mm Hg).Your blood test shows high levels of creatinine, a waste product in the blood.You have had bleeding inside your brain confirmed by a brain CT or MRI.I have a brain bleed caused by an unsecured AVM.I have a bleeding disorder that affects my daily life.You are allergic to aspirin or apixaban.I have long-term low blood counts, either anemia or low platelets.I had a brain hemorrhage between 2 weeks and 6 months ago.My stroke turned into bleeding in the brain or a tumor.I am 18 years old or older.I had a brain hemorrhage less than a year ago.
Research Study Groups:
This trial has the following groups:- Group 1: Apixaban
- Group 2: Aspirin
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there other examples of Apixaban being used in research?
"The first clinical trial for apixaban was conducted in 2002 at Institut Curie Hopital. As of right now, there have been a total of 621 completed trials. At the moment, 222 trials are actively recruiting participants. A large portion of these trials are based in Allentown, Pennsylvania."
Answered by AI
In how many hospitals is this clinical trial being run?
"Lehigh Valley Hospital - Cedar Crest in Allentown, Pennsylvania, University of California, Irvine in Orange, California, and Montefiore Medical Center in Bronx, New york are all conducting this clinical trial as well as 100 other medical facilities."
Answered by AI
How many research subjects can enroll in this investigation?
"The listed information on clinicaltrials.gov affirms that this research is still looking for participants. This trial was originally posted on 1/28/2020 and was updated as recently as 7/28/2022. They are hoping to enroll 700 individuals from 100 unique sites."
Answered by AI
Is this a clinical trial that is breaking new ground?
"There are a total of 222 clinical trials currently underway for the drug Apixaban. These studies are being conducted in 1503 cities, across 65 different countries and began in 2002. The first study, sponsored by Sanofi, had 413 participants and completed Phase 3 approval. Since then, 621 additional studies have been completed."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
San Francisco General Hospital
Yale New Haven Hospital
WVU Healthcare Ruby Memorial Hospital
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
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