Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Atrial Fibrillation Occurring Transiently With Stress

What this study is about

Multinational, investigator-initiated study of oral anticoagulation versus no anticoagulation for the prevention of stroke and other adverse cardiovascular events in patients with transient atrial fibrillation occurring transiently with stress and additional stroke risk factors.

Who can join (things the study team will check)

✅ You may be able to join if…

• have ≥1 episode of clinically important AFOTS during any of the following conditions:
  • noncardiac surgery in the past 35 days, with at least an overnight hospital admission aftersurgery;
  • noncardiac day surgery resulting in a large enough physiological insult to be able to cause AFOTS, as judged by the local investigator; or
  • 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;
• sinus rhythm at the time of randomization;
• any of the following high-risk criteria:
  • age 55-64 years, and having either known cardiovascular disease, recent major vascular surgery, a CHA2DS2VASc score ≥3, or an elevated postoperative troponin level;
  • 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
  • age ≥75 years.;
• provide written informed consent

🚫 You may not be able to join if…

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

Where this trial is running

• Cedars-Sinai Medical Center, Los Angeles, California, United States
• Mcgovern Medical School at University of Texas, Houston, Texas, United States
• Clinica Coronel Suarez, Coronel Suárez, Buenos Aires, Argentina
• Instituto de Investigaciones Clinicas Rosario, Rosario, Santa Fe Province, Argentina
• Instituto Cardiovascular de Rosario, Rosario, Santa Fe Province, Argentina
• Centro Integral de Arritmias de Tucuman (CIAT), San Miguel de Tucumán, Tucumán Province, Argentina
• Hospital Municipal Chivilcoy, Chivilcoy, Argentina
• Sanatorio Cisma, San Miguel de Tucumán, Argentina
• Hospital Privado de Rosario, Santa Fe, Argentina
• Canberra Hospital, Garran, Australian Capital Territory, Australia
• Bankstown Hospital, Bankstown, New South Wales, Australia
• Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

+ 93 more sites.

Who to contact

Cassie McDonald · 1-905-594-0560 · aspireaf@phri.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT03968393.