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Preventing strokes in patients with recent atrial fibrillation after noncardiac surgery

Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Atrial Fibrillation Occurring Transiently With Stress - The ASPIRE-AF Trial

PHASE4 · Population Health Research Institute · NCT03968393

This study is testing whether a new type of blood thinner can help prevent strokes in patients who had temporary heart rhythm issues after non-heart surgery.

Quick facts

PhasePHASE4
Study typeInterventional
Enrollment2270 (estimated)
Ages55 Years and up
SexAll
SponsorPopulation Health Research Institute (other)
Locations105 sites (Los Angeles, California and 104 other locations)
Trial IDNCT03968393 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of non-vitamin K oral anticoagulants (NOACs) compared to no anticoagulation in preventing strokes and other cardiovascular events in patients who experienced transient atrial fibrillation after noncardiac surgery. It is a multinational, randomized, open-label trial that focuses on patients with additional stroke risk factors. The primary outcomes include non-hemorrhagic stroke, systemic embolism, and various cardiovascular events over the follow-up period.

Who should consider this trial

Good fit: Ideal candidates are patients who have had noncardiac surgery within the past 35 days and experienced at least one episode of clinically important perioperative atrial fibrillation.

Not a fit: Patients with a history of chronic atrial fibrillation prior to surgery are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the incidence of strokes and other serious cardiovascular events in at-risk patients following surgery.

How similar studies have performed: Other studies have shown promise in using anticoagulation for stroke prevention in similar patient populations, suggesting this approach may be effective.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. have ≥1 episode of clinically important AFOTS during any of the following conditions:

   1. noncardiac surgery in the past 35 days, with at least an overnight hospital admission aftersurgery;
   2. noncardiac day surgery resulting in a large enough physiological insult to be able to cause AFOTS, as judged by the local investigator; or
   3. acute medical illness requiring hospital admission in the past 35 days and resulting in a large enough physiological insult to be able to cause AFOTS, as judged by the local investigator;
2. sinus rhythm at the time of randomization;
3. any of the following high-risk criteria:

   1. age 55-64 years, and having either known cardiovascular disease, recent major vascular surgery, a CHA2DS2VASc score ≥3, or an elevated postoperative troponin level;
   2. age 65-74 years, and having either known cardiovascular disease, recent major vascular surgery, a CHA2DS2VASc score ≥2, or an elevated postoperative troponin level; OR
   3. age ≥75 years.;
4. provide written informed consent

Exclusion Criteria:

1. any cardiac diagnosis as the primary reason for hospital admission;
2. history of documented chronic AF prior to noncardiac surgery;
3. need for long-term systemic anticoagulation;
4. ongoing need for long-term dual antiplatelet treatment;
5. contraindication to oral anticoagulation;
6. severe renal insufficiency (CrCl \<20 ml/min);
7. severe liver cirrhosis (i.e., Child-Pugh Class C)
8. acute stroke in the past 14 days;
9. underwent cardiac surgery in the past 35 days;
10. history of nontraumatic intracranial, intraocular, or spinal bleeding;
11. hemorrhagic disorder or bleeding diathesis;
12. expected to be non-compliant with follow-up and/or study medications;
13. known life expectancy less than 1 year due to concomitant disease;
14. women who are pregnant, breastfeeding, or of childbearing potential who are not taking effective contraception; OR
15. previously enrolled in the trial

Where this trial is running

Los Angeles, California and 104 other locations

+55 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Stroke, Atrial Fibrillation, Transient Atrial Fibrillation, Perioperative Atrial Fibrillation, Non-vitamin K Oral Anticoagulation, Noncardiac Surgery, PROBE Design, Medical Illness

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.