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

RecruitingPhase 4Ages 55 Years - anyAllPopulation Health Research Institute
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Non-vitamin K oral anticoagulant (NOAC)
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Where

105 sites
Cedars-Sinai Medical Center
Los Angeles, United States
Mcgovern Medical School at University of Texas
Houston, United States
Clinica Coronel Suarez
Coronel Suárez, Argentina
Instituto de Investigaciones Clinicas Rosario
Rosario, Argentina
Instituto Cardiovascular de Rosario
Rosario, Argentina
Centro Integral de Arritmias de Tucuman (CIAT)
San Miguel de Tucumán, Argentina
Hospital Municipal Chivilcoy
Chivilcoy, Argentina
Sanatorio Cisma
San Miguel de Tucumán, Argentina

…and 97 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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