Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Perioperative AF After Noncardiac Surgery (ASPIRE-AF)
Stroke, Atrial Fibrillation
About this trial
This is an interventional prevention trial for Stroke focused on measuring Transient Atrial Fibrillation, Perioperative Atrial Fibrillation, Non-vitamin K Oral Anticoagulation, Noncardiac Surgery, PROBE Design
Eligibility Criteria
Inclusion Criteria:
- noncardiac surgery with at least an overnight hospital admission after surgery in the last 35 days;
- ≥1 episode of clinically important perioperative AF during or after their surgery;
- sinus rhythm at the time of randomization; AND
any of the following high-risk criteria:
- age 55-74 years, and having either known cardiovascular disease, recent major vascular surgery, or a CHA2DS2VASc score ≥3;OR
- age ≥75 years.
Exclusion Criteria:
- history of documented 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 (eGFR <30 ml/min);
- acute stroke in the past 3 months;
- underwent cardiac surgery in the past 3 months;
- 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
Sites / Locations
- Hospital Municipal Chivilcoy
- Hospital Privado de Rosario
- Sanatorio Cisma
- Canberra Hospital
- Royal Prince Alfred HospitalRecruiting
- Concord Repatriation General HospitalRecruiting
- John Hunter HospitalRecruiting
- Westmead HospitalRecruiting
- Wollongong Hospital
- Wesley & Greenscopes Private Hospitals
- Royal Brisbane and Women's Hospital
- Monash Medical Centre
- Royal Perth HospitalRecruiting
- Instituto do Coração do Hospital das Clínicas da FMUSP
- Hospital de Clinicas de Porto Alegre
- University of Alberta HospitalRecruiting
- Health Sciences Centre Winnipeg
- Halifax InfirmaryRecruiting
- Hamilton General HospitalRecruiting
- St. Joseph's Healthcare HamiltonRecruiting
- Juravinski HospitalRecruiting
- Kingston General HospitalRecruiting
- London Health Sciences Centre - University HospitalRecruiting
- The Ottawa Hospital General CampusRecruiting
- Niagara Health System - St. Catharine's SiteRecruiting
- Centre Hospitalier de l'Université de MontréalRecruiting
- Hôpital Fleurimont du Centre hospitalier universitaire de SherbrookeRecruiting
- Royal University Hospital
- Aarhus University Hospital
- Hospital South West Jutland - University Hospital of Southern DenmarkRecruiting
- Odense University HospitalRecruiting
- Universitatsklinikum Leipzig
- NU Hospitals
- Amala Institute
- Jehangir Clinical Development Centre
- St. John's Medical College Hospital
- NU Hospitals
- Bangalore Baptist Hospital
- JIPMER
- Ruby Hall Clinic
- Trivandrum Medical
- Government Medical College
- ASST Grande Ospedale Metropolitano Niguarda
- Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo
- Fondazione IRCCS Ca'Granda Ospedale Maggiore PoliclinicoRecruiting
- La Maddalena
- Piacenza Ospedale
- San Luigi Gonzaga
- B and B HospitalRecruiting
- Jeroen Bosch HospitalRecruiting
- Noordwest ZiekenhuisgroepRecruiting
- ZiekenhuisGroepTwente (ZGT)Recruiting
- Ziekenhuis AmstellandRecruiting
- Rijnstate HospitalRecruiting
- Deventer ZiekenhuisRecruiting
- Hospital Gelderse ValleiRecruiting
- Martini HospitalRecruiting
- Franciscus GasthuisRecruiting
- Ikazia HospitalRecruiting
- ETZ TilburgRecruiting
- Dunedin Public Hospital
- Waikato Hospital
- Shifa International Hospital
- Dow Medical University
- Hospital de Mar
- Vall d'Hebron Hospital
- Hospital de la Santa Creu i Sant PauRecruiting
- University Hospital Ramon y Cajal
- Uppsala University
- Blackpool Teaching Hospital
- Liverpool Heart and Chest Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Non-vitamin K oral anticoagulant (NOAC)
No anticoagulation
Participants randomized to the intervention arm will be prescribed one of the following NOACs for 24 months, 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.
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.