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Clinical Trials in India / NCT03968393
Recruiting Phase 4

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

NCT03968393 · tracked via the Priya Life Science India tracker
Sponsor
Population Health Research Institute
Phase
Phase 4
Started
2019-06-14
Last updated
2026-01-12

Condition(s) studied

StrokeAtrial Fibrillation

Investigational drug(s) / intervention(s)

Non-vitamin K oral anticoagulant (NOAC)

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
55 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (105)

FacilityCityRegionStatus
Cedars-Sinai Medical Center Los Angeles California Recruiting
Mcgovern Medical School at University of Texas Houston Texas Recruiting
Clinica Coronel Suarez Coronel Suárez Buenos Aires Recruiting
Instituto de Investigaciones Clinicas Rosario Rosario Santa Fe Province Recruiting
Instituto Cardiovascular de Rosario Rosario Santa Fe Province Recruiting
Centro Integral de Arritmias de Tucuman (CIAT) San Miguel de Tucumán Tucumán Province Recruiting
Hospital Municipal Chivilcoy Chivilcoy Argentina Recruiting
Sanatorio Cisma San Miguel de Tucumán Argentina Recruiting
Hospital Privado de Rosario Santa Fe Argentina Not Yet Recruiting
Canberra Hospital Garran Australian Capital Territory Recruiting
Bankstown Hospital Bankstown New South Wales Recruiting
Royal Prince Alfred Hospital Camperdown New South Wales Recruiting
Concord Repatriation General Hospital Concord New South Wales Recruiting
Liverpool Hospital Liverpool New South Wales Not Yet Recruiting
John Hunter Hospital Newcastle New South Wales Recruiting
Westmead Hospital Westmead New South Wales Recruiting
Sunshine Coast Hospital and Health Service Birtinya Queensland Recruiting
Royal Brisbane and Women's Hospital Herston Queensland Not Yet Recruiting
Redcliffe Hospital Redcliffe Queensland Recruiting
Royal Adelaide Hospital Adelaide South Australia Not Yet Recruiting
Box Hill Hospital Box Hill Victoria Recruiting
Northeast Health Wangaratta Wangaratta Victoria Recruiting
Royal Perth Hospital Perth Western Australia Recruiting
Instituto do Coração do Hospital das Clínicas da FMUSP Cerqueira César Brazil Recruiting
Hospital de Clinicas de Porto Alegre Porto Alegre Brazil Recruiting
Foothills Hospital Calgary Alberta Recruiting
University of Alberta Hospital Edmonton Alberta Recruiting
Medicine Hat Regional Hospital Medicine Hat Alberta Recruiting
East Kootenay Regional Hospital Cranbrook British Columbia Not Yet Recruiting
Fraser Health Authority Surrey British Columbia Recruiting
Vancouver General Hospital Vancouver British Columbia Recruiting
Health Sciences Centre Winnipeg Winnipeg Manitoba Recruiting
Dr.-Georges-L.-Dumont University Hospital Centre Moncton New Brunswick Not Yet Recruiting
Halifax Infirmary Halifax Nova Scotia Recruiting
Cape Breton University Sydney Nova Scotia Recruiting
Cambridge Cardiac Care Centre Cambridge Ontario Not Yet Recruiting
Hamilton General Hospital Hamilton Ontario Recruiting
St. Joseph's Healthcare Hamilton Hamilton Ontario Recruiting
Juravinski Hospital Hamilton Ontario Recruiting
Kingston General Hospital Kingston Ontario Recruiting

+ 65 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03968393 on ClinicalTrials.gov ↗ ← All trials in India