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

Recruiting now · Phase 4

Conditions studied: Stroke, Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT03968393

Run by

Population Health Research Institute

People needed

2270

Starts

2019-06-14

Expected to finish

2028-12-01

Last updated by the study team

2026-01-12

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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 it is running

• University of Alberta Hospital — Edmonton, Alberta, Canada (enrolling)
• Medicine Hat Regional Hospital — Medicine Hat, Alberta, Canada (enrolling)
• Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
• Foothills Hospital — Calgary, Alberta, Canada (enrolling)
• Centro Integral de Arritmias de Tucuman (CIAT) — San Miguel de Tucumán, Tucumán Province, Argentina (enrolling)
• Clinica Coronel Suarez — Coronel Suárez, Buenos Aires, Argentina (enrolling)
• Sanatorio Cisma — San Miguel de Tucumán, Argentina (enrolling)
• Mcgovern Medical School at University of Texas — Houston, Texas, United States (enrolling)
• Instituto Cardiovascular de Rosario — Rosario, Santa Fe Province, Argentina (enrolling)
• Bankstown Hospital — Bankstown, New South Wales, Australia (enrolling)
• Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia (enrolling)
• Concord Repatriation General Hospital — Concord, New South Wales, Australia (enrolling)
• Hospital Municipal Chivilcoy — Chivilcoy, Argentina (enrolling)
• John Hunter Hospital — Newcastle, New South Wales, Australia (enrolling)
• Westmead Hospital — Westmead, New South Wales, Australia (enrolling)
• Sunshine Coast Hospital and Health Service — Birtinya, Queensland, Australia (enrolling)
• Instituto de Investigaciones Clinicas Rosario — Rosario, Santa Fe Province, Argentina (enrolling)
• Redcliffe Hospital — Redcliffe, Queensland, Australia (enrolling)
• Canberra Hospital — Garran, Australian Capital Territory, Australia (enrolling)
• Box Hill Hospital — Box Hill, Victoria, Australia (enrolling)
• Northeast Health Wangaratta — Wangaratta, Victoria, Australia (enrolling)
• Royal Perth Hospital — Perth, Western Australia, Australia (enrolling)
• Instituto do Coração do Hospital das Clínicas da FMUSP — Cerqueira César, Brazil (enrolling)
• Hospital de Clinicas de Porto Alegre — Porto Alegre, Brazil (enrolling)
• Fraser Health Authority — Surrey, British Columbia, Canada (enrolling)

Full record on ClinicalTrials.gov

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