Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Perioperative AF After Noncardiac Surgery
Atrial Fibrillation | StrokeMultinational, investigator-initiated study of oral anticoagulation versus no anticoagulation for the prevention of stroke and other adverse cardiovascular events in patients with transient perioperative atrial fibrillation after noncardiac surgery and additional stroke risk factors.
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Conditions de participation
-
Sexe:
ALL -
Âges admissibles:
55 and up
Critères de participation
Inclusion Criteria:
1. noncardiac surgery in the past 35 days with at least one of the following:
1. an overnight hospital admission after surgery;
2. day surgery resulting in a large enough physiological insult to be able to cause perioperative AF, as judged by the local investigator
2. ≥1 episode of clinically important perioperative AF during or after their surgery;
3. sinus rhythm at the time of randomization; AND
4. 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.
5. provide written informed consent
Exclusion Criteria:
1. history of documented chronic AF prior to noncardiac surgery;
2. need for long-term systemic anticoagulation;
3. ongoing need for long-term dual antiplatelet treatment;
4. contraindication to oral anticoagulation;
5. severe renal insufficiency (CrCl \<20 ml/min);
6. severe liver cirrhosis (i.e., Child-Pugh Class C)
7. acute stroke in the past 14 days;
8. underwent cardiac surgery in the past 35 days;
9. history of nontraumatic intracranial, intraocular, or spinal bleeding;
10. hemorrhagic disorder or bleeding diathesis;
11. expected to be non-compliant with follow-up and/or study medications;
12. known life expectancy less than 1 year due to concomitant disease;
13. women who are pregnant, breastfeeding, or of childbearing potential who are not taking effective contraception; OR
14. previously enrolled in the trial
Lieu de l'étude
University of Alberta Hospital
University of Alberta HospitalEdmonton, Alberta
Canada
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Health Sciences Centre Winnipeg
Health Sciences Centre WinnipegWinnipeg, Manitoba
Canada
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Cambridge Cardiac Care Centre
Cambridge Cardiac Care CentreCambridge, Ontario
Canada
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Kingston General Hospital
Kingston General HospitalKingston, Ontario
Canada
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Centre Hospitalier de l'Université de Montréal
Centre Hospitalier de l'Université de MontréalMontréal, Quebec
Canada
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Royal University Hospital
Royal University HospitalSaskatoon, Saskatchewan
Canada
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Foothills Hospital
Foothills HospitalCalgary, Alberta
Canada
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Fraser Health Authority
Fraser Health AuthoritySurrey, British Columbia
Canada
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Cape Breton University
Cape Breton UniversitySydney, Nova Scotia
Canada
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Juravinski Hospital
Juravinski HospitalHamilton, Ontario
Canada
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Niagara Health System - St. Catharine's Site
Niagara Health System - St. Catharine's SiteSt. Catharines, Ontario
Canada
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Regina General Hospital
Regina General HospitalRegina, Saskatchewan
Canada
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Medicine Hat Regional Hospital
Medicine Hat Regional HospitalMedicine Hat, Alberta
Canada
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Dr.-Georges-L.-Dumont University Hospital Centre
Dr.-Georges-L.-Dumont University Hospital CentreMoncton, New Brunswick
Canada
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Hamilton General Hospital
Hamilton General HospitalHamilton, Ontario
Canada
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London Health Sciences Centre - University Hospital
London Health Sciences Centre - University HospitalLondon, Ontario
Canada
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CHU de Quebec Universite Laval
CHU de Quebec Universite LavalQuébec, Quebec
Canada
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East Kootenay Regional Hospital
East Kootenay Regional HospitalCranbrook, British Columbia
Canada
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Halifax Infirmary
Halifax InfirmaryHalifax, Nova Scotia
Canada
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St. Joseph's Healthcare Hamilton
St. Joseph's Healthcare HamiltonHamilton, Ontario
Canada
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The Ottawa Hospital General Campus
The Ottawa Hospital General CampusOttawa, Ontario
Canada
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Hôpital Fleurimont du Centre hospitalier universitaire de Sherbrooke
Hôpital Fleurimont du Centre hospitalier universitaire de SherbrookeSherbrooke, Quebec
Canada
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- Étude parrainée par
- Population Health Research Institute
- Participants recherchés
- Plus d'informations
- ID de l'étude:
NCT03968393