Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Perioperative AF After Noncardiac Surgery
- Conditions
- StrokeAtrial Fibrillation
- Interventions
- Drug: Non-vitamin K oral anticoagulant (NOAC)
- Registration Number
- NCT03968393
- Lead Sponsor
- Population Health Research Institute
- Brief 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 perioperative atrial fibrillation after noncardiac surgery and additional stroke risk factors.
- Detailed Description
ASPIRE-AF is a prospective, randomized, open-label trial of non-vitamin K oral anticoagulants (NOACs) versus no oral anticoagulation in patients with transient perioperative atrial fibrillation and additional stroke factors after noncardiac surgery. The primary objective is to assess the effects of NOACs versus no anticoagulation on the co-primary composite outcomes of 1. non-hemorrhagic stroke and systemic embolism, and 2. vascular mortality, and non-fatal non-hemorrhagic stroke, myocardial infarction, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism over the duration of follow-up.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2270
-
noncardiac surgery in the past 35 days with at least one of the following:
- an overnight hospital admission after surgery;
- day surgery resulting in a large enough physiological insult to be able to cause perioperative AF, as judged by the local investigator
-
≥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 55-64 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 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, 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.
- Primary Outcome Measures
Name Time Method Incidence of vascular mortality, and non-fatal non-hemorrhagic stroke, myocardial infarction, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months) Incidence of Non-hemorrhagic stroke or systemic embolism For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
- Secondary Outcome Measures
Name Time Method Incidence of non-fatal, non-hemorrhagic stroke For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months) Incidence of vascular mortality For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months) Incidence of peripheral arterial thrombosis For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months) Incidence of all-cause mortality For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months) Incidence of Myocardial infarction For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months) Incidence of symptomatic venous thromboembolism For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months) Incidence of all-cause stroke For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months) Incidence of amputation For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
Trial Locations
- Locations (90)
Box Hill Hospital
🇦🇺Box Hill, Victoria, Australia
Rijnstate Hospital
🇳🇱Arnhem, Netherlands
Dunedin Public Hospital
🇳🇿Dunedin, New Zealand
Clinica Coronel Suarez
🇦🇷Coronel Suárez, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Rosario
🇦🇷Rosario, Santa Fe, Argentina
Centro Integral de Arritmias de Tucuman (CIAT)
🇦🇷San Miguel De Tucumán, Tucuman, Argentina
Hospital Municipal Chivilcoy
🇦🇷Chivilcoy, Argentina
Hospital Privado de Rosario
🇦🇷Santa Fe, Argentina
Sanatorio Cisma
🇦🇷Tucuman, 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
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
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
Centre Hospitalier de l'Université de Montréal
🇨🇦Montréal, 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
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
🇮🇳Thrissur, Kerala, India
St. John's Medical College Hospital
🇮🇳Bangalore, India
Bangalore Baptist Hospital
🇮🇳Bengaluru, India
JIPMER
🇮🇳Pondicherry, India
Ruby Hall Clinic
🇮🇳Pune, India
Trivandrum Medical
🇮🇳Thiruvananthapuram, India
ASST Grande Ospedale Metropolitano Niguarda
🇮🇹Milano, 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
Korea University Ansm Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
B and B Hospital
🇳🇵Lalitpur, Nepal
Jeroen Bosch Hospital
🇳🇱's-Hertogenbosch, Netherlands
Noordwest Ziekenhuisgroep
🇳🇱Alkmaar, Netherlands
ZiekenhuisGroepTwente (ZGT)
🇳🇱Almelo, Netherlands
Ziekenhuis Amstelland
🇳🇱Amstelveen, 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
Waikato Hospital
🇳🇿Hamilton, New Zealand
Aga Khan University
🇵🇰Karachi, Sindh, Pakistan
Shifa International Hospital
🇵🇰Islamabad, Pakistan
Dow Medical University
🇵🇰Karachi, Pakistan
Hospital de Mar
🇪🇸Barcelona, Spain
Vall d'Hebron Hospital
🇪🇸Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
University Hospital Ramon y Cajal
🇪🇸Madrid, Spain
Uppsala University
🇸🇪Uppsala, Sweden
University Hospital Basel
🇨🇭Basel, Switzerland
Blackpool Teaching Hospital
🇬🇧Blackpool, Lancashire, United Kingdom
Liverpool Heart and Chest Hospital
🇬🇧Liverpool, United Kingdom