Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Atrial Fibrillation Occurring Transiently With Stress
NCT ID: NCT03968393
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
2270 participants
INTERVENTIONAL
2019-06-14
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Non-vitamin K oral anticoagulant (NOAC)
Participants randomized to the intervention arm will be prescribed one of the following NOACs for the duration of follow-up, unless they are undergoing a procedure with an increased risk of bleeding, have an adverse event or low calculated creatinine clearance, or decide to discontinue their use.
Non-vitamin K oral anticoagulant (NOAC)
Participants randomized to the intervention arm will be prescribed one of the following NOACs for the duration of follow-up: edoxaban 60 mg daily (dose reduction to 30 mg, if applicable), apixaban 5 mg twice daily (dose reduction to 2.5 mg, if applicable), dabigatran 110 mg twice daily, or rivaroxaban 20 mg daily (dose reduction to 15 mg, if applicable). The choice of NOAC will be left up to the participant's prescribing physician.
No anticoagulation
Participants randomized to the control arm will not be prescribed an oral anticoagulant unless they develop a clear indication for one during follow-up (e.g., recurrent nonoperative AF). They can be newly prescribed or continue taking low dose aspirin or another single antiplatelet agent as per the protocol. This will be decided by the participant's physician.
No interventions assigned to this group
Interventions
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Non-vitamin K oral anticoagulant (NOAC)
Participants randomized to the intervention arm will be prescribed one of the following NOACs for the duration of follow-up: edoxaban 60 mg daily (dose reduction to 30 mg, if applicable), apixaban 5 mg twice daily (dose reduction to 2.5 mg, if applicable), dabigatran 110 mg twice daily, or rivaroxaban 20 mg daily (dose reduction to 15 mg, if applicable). The choice of NOAC will be left up to the participant's prescribing physician.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
55 Years
ALL
No
Sponsors
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Hamilton Health Sciences Corporation
OTHER
Population Health Research Institute
OTHER
Responsible Party
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Principal Investigators
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David Conen, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Population Health Research Institute
PJ Devereaux, MD, PhD
Role: STUDY_CHAIR
Population Health Research Institute
Locations
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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
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
John Hunter Hospital
Newcastle, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Sunshine Coast Hospital and Health Service
Birtinya, Queensland, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Redcliffe Hospital
Redcliffe, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Northeast Health Wangaratta
Wangaratta, Victoria, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Instituto do Coração do Hospital das Clínicas da FMUSP
Cerqueira César, , Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, , Brazil
Foothills Hospital
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Medicine Hat Regional Hospital
Medicine Hat, Alberta, Canada
East Kootenay Regional Hospital
Cranbrook, British Columbia, Canada
Fraser Health Authority
Surrey, British Columbia, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
Health Sciences Centre Winnipeg
Winnipeg, Manitoba, Canada
Dr.-Georges-L.-Dumont University Hospital Centre
Moncton, New Brunswick, Canada
Halifax Infirmary
Halifax, Nova Scotia, Canada
Cape Breton University
Sydney, Nova Scotia, Canada
Cambridge Cardiac Care Centre
Cambridge, Ontario, Canada
Hamilton General Hospital
Hamilton, Ontario, Canada
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Juravinski Hospital
Hamilton, Ontario, Canada
Kingston General Hospital
Kingston, Ontario, Canada
London Health Sciences Centre - University Hospital
London, Ontario, Canada
The Ottawa Hospital General Campus
Ottawa, Ontario, Canada
Niagara Health System - St. Catharine's Site
St. Catharines, Ontario, Canada
Cortelluci Vaughan Hospital
Vaughan, Ontario, Canada
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
CHU de Quebec Universite Laval
Québec, Quebec, Canada
Hôpital Fleurimont du Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Regina General Hospital
Regina, Saskatchewan, Canada
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Aarhus University Hospital
Aarhus, , Denmark
Hospital South West Jutland - University Hospital of Southern Denmark
Esbjerg, , Denmark
Odense University Hospital
Odense, , Denmark
Southwest Finland Wellbeing County (VARHA)
Turku, , Finland
Universitatsklinikum Leipzig
Leipzig, , Germany
GNRC Medical
North Guwāhāti, Assam, India
Marengo CIMS Hospital
Ahmedabad, Gujarat, India
NU Hospitals
Bangalore, Karnataka, India
Govt. T.D. Medical College
Alappuzha, Kerala, India
Amala Institute of Medical Sciences
Thrissur, Kerala, India
Amala Institute
Thrissur, Kerala, India
St. John's Medical College Hospital
Bangalore, , India
JIPMER
Puducherry, , India
Ruby Hall Clinic
Pune, , India
Trivandrum Medical
Thiruvananthapuram, , India
ASST Grande Ospedale Metropolitano Niguarda
Milan, Milan, Italy
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo
Alessandria, , Italy
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
Milan, , Italy
La Maddalena
Palermo, , Italy
Piacenza Ospedale
Piacenza, , Italy
Nobel Medical College Teaching Hospital
Biratnagar, , Nepal
B.P. Koirala Institute of Health Sciences
Koshi, , Nepal
B and B Hospital
Lalitpur, , Nepal
Jeroen Bosch Hospital
's-Hertogenbosch, , Netherlands
Noordwest Ziekenhuisgroep
Alkmaar, , Netherlands
ZiekenhuisGroepTwente (ZGT)
Almelo, , Netherlands
Ziekenhuis Amstelland
Amstelveen, , Netherlands
Rijnstate Hospital
Arnhem, , Netherlands
Amphia Ziekenhuis Breda
Breda, , Netherlands
Deventer Ziekenhuis
Deventer, , Netherlands
Hospital Gelderse Vallei
Ede, , Netherlands
Martini Hospital
Groningen, , Netherlands
Franciscus Gasthuis
Rotterdam, , Netherlands
Ikazia Hospital
Rotterdam, , Netherlands
ETZ Tilburg
Tilburg, , Netherlands
Aga Khan University
Karachi, Sindh, Pakistan
Maroof International Hospital
Islamabad, , Pakistan
Shifa International Hospital
Islamabad, , Pakistan
Dow Medical University
Karachi, , Pakistan
Rehman Medical Institute
Peshawar, , Pakistan
Korea Univesrity Anam Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Seoul National University Bundang Hospital
Seoul, , South Korea
Hospital de Mar
Barcelona, Barcelona, Spain
Vall d'Hebron Hospital
Barcelona, Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Mutua de Terrassa
Barcelona, , Spain
University Hospital Ramon y Cajal
Madrid, , Spain
Hospital Universitario de Navarra
Pamplona, , Spain
Karolinska Institutet Danderyd Hospital
Danderyd, , Sweden
Uppsala University
Uppsala, , Sweden
University Hospital Basel
Basel, Basel, Switzerland
Kantonsspital St. Gallen
Sankt Gallen, , Switzerland
Kantonsspital Winterthur
Winterthur, , Switzerland
Liverpool Heart and Chest Hospital
Liverpool, , United Kingdom
Southend Hospital
Westcliff-on-Sea, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2023-509142-35-00
Identifier Type: CTIS
Identifier Source: secondary_id
2019-001336-62
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2019-ASPIREAF
Identifier Type: -
Identifier Source: org_study_id
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