Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Atrial Fibrillation Occurring Transiently With Stress
Recruiting · NCT03968393 · Interventional (participants receive a specific treatment) · Lead sponsor: Population Health Research Institute
View the official record on ClinicalTrials.gov →Interventions studied
Non-vitamin K oral anticoagulant (NOAC)
What this trial is about
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.
Who can take part
Age range
55 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
60 locations listed across 2 US states.
- Cedars-Sinai Medical Center - Los Angeles, California, United States
- Mcgovern Medical School at University of Texas - Houston, Texas, United States
- Jeroen Bosch Hospital - 's-Hertogenbosch, Netherlands
- Aarhus University Hospital - Aarhus, Denmark
- Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo - Alessandria, Italy
- Noordwest Ziekenhuisgroep - Alkmaar, Netherlands
- ZiekenhuisGroepTwente (ZGT) - Almelo, Netherlands
- Ziekenhuis Amstelland - Amstelveen, Netherlands
- Rijnstate Hospital - Arnhem, Netherlands
- St. John's Medical College Hospital - Bangalore, India
- Hospital de la Santa Creu i Sant Pau - Barcelona, Spain
- Hospital Mutua de Terrassa - Barcelona, Spain
- Nobel Medical College Teaching Hospital - Biratnagar, Nepal
- Amphia Ziekenhuis Breda - Breda, Netherlands
- Instituto do Coração do Hospital das Clínicas da FMUSP - Cerqueira César, Brazil
- Hospital Municipal Chivilcoy - Chivilcoy, Argentina
- Karolinska Institutet Danderyd Hospital - Danderyd, Sweden
- Deventer Ziekenhuis - Deventer, Netherlands
- Hospital Gelderse Vallei - Ede, Netherlands
- Hospital South West Jutland - University Hospital of Southern Denmark - Esbjerg, Denmark
- Martini Hospital - Groningen, Netherlands
- Maroof International Hospital - Islamabad, Pakistan
- Shifa International Hospital - Islamabad, Pakistan
- Dow Medical University - Karachi, Pakistan
- B.P. Koirala Institute of Health Sciences - Koshi, Nepal
- B and B Hospital - Lalitpur, Nepal
- Universitatsklinikum Leipzig - Leipzig, Germany
- Liverpool Heart and Chest Hospital - Liverpool, United Kingdom
- University Hospital Ramon y Cajal - Madrid, Spain
- Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico - Milan, Italy
- Odense University Hospital - Odense, Denmark
- La Maddalena - Palermo, Italy
- Hospital Universitario de Navarra - Pamplona, Spain
- Rehman Medical Institute - Peshawar, Pakistan
- Piacenza Ospedale - Piacenza, Italy
- Hospital de Clinicas de Porto Alegre - Porto Alegre, Brazil
- JIPMER - Puducherry, India
- Ruby Hall Clinic - Pune, India
- Franciscus Gasthuis - Rotterdam, Netherlands
- Ikazia Hospital - Rotterdam, Netherlands
- Sanatorio Cisma - San Miguel de Tucumán, Argentina
- Kantonsspital St. Gallen - Sankt Gallen, Switzerland
- Hospital Privado de Rosario - Santa Fe, Argentina
- Korea Univesrity Anam Hospital - Seoul, South Korea
- Seoul National University Hospital - Seoul, South Korea
- Seoul National University Bundang Hospital - Seoul, South Korea
- Trivandrum Medical - Thiruvananthapuram, India
- ETZ Tilburg - Tilburg, Netherlands
- Southwest Finland Wellbeing County (VARHA) - Turku, Finland
- Uppsala University - Uppsala, Sweden
- Southend Hospital - Westcliff-on-Sea, United Kingdom
- Kantonsspital Winterthur - Winterthur, Switzerland
- Foothills Hospital - Calgary, Alberta, Canada
- University of Alberta Hospital - Edmonton, Alberta, Canada
- Medicine Hat Regional Hospital - Medicine Hat, Alberta, Canada
- GNRC Medical - North Guwāhāti, Assam, India
- Canberra Hospital - Garran, Australian Capital Territory, Australia
- Hospital de Mar - Barcelona, Barcelona, Spain
- Vall d'Hebron Hospital - Barcelona, Barcelona, Spain
- University Hospital Basel - Basel, Basel, Switzerland
Showing 60 of 105 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →