Preventing strokes in patients with recent atrial fibrillation after noncardiac surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting
• Mcgovern Medical School at University of Texas
  Houston, Texas, United States Recruiting
• Clinica Coronel Suarez
  Coronel Suárez, Buenos Aires, Argentina Recruiting
• Instituto de Investigaciones Clinicas Rosario
  Rosario, Santa Fe Province, Argentina Recruiting
• Instituto Cardiovascular de Rosario
  Rosario, Santa Fe Province, Argentina Recruiting
• Centro Integral de Arritmias de Tucuman (CIAT)
  San Miguel de Tucumán, Tucumán Province, Argentina Recruiting

+55 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: David Conen, MD, MPH — Population Health Research Institute
• Study coordinator: Cassie McDonald
• Email: aspireaf@phri.ca
• Phone: 1-905-594-0560

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.