Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Atrial Fibrillation Occurring Transiently With Stress
ASPIRE-AF
3 other identifiers
interventional
2,270
18 countries
105
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 atrial fibrillation occurring transiently with stress and additional stroke risk factors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 stroke
Started Jun 2019
Longer than P75 for phase_4 stroke
105 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2019
CompletedFirst Posted
Study publicly available on registry
May 30, 2019
CompletedStudy Start
First participant enrolled
June 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
January 12, 2026
January 1, 2026
9.5 years
March 22, 2019
January 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
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)
Secondary Outcomes (8)
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 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 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 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 amputation
For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
- +3 more secondary outcomes
Other Outcomes (5)
Incidence of composite of life-threatening, major, and critical organ bleeding
For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
Incidence of major bleeding
For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
Incidence of hemorrhagic stroke
For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
- +2 more other outcomes
Study Arms (2)
Non-vitamin K oral anticoagulant (NOAC)
EXPERIMENTALParticipants 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.
No anticoagulation
NO INTERVENTIONParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (105)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Mcgovern Medical School at University of Texas
Houston, Texas, 77030, United States
Clinica Coronel Suarez
Coronel Suárez, Buenos Aires, 7540, Argentina
Instituto de Investigaciones Clinicas Rosario
Rosario, Santa Fe Province, 2000, Argentina
Instituto Cardiovascular de Rosario
Rosario, Santa Fe Province, S2000, Argentina
Centro Integral de Arritmias de Tucuman (CIAT)
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Hospital Municipal Chivilcoy
Chivilcoy, B6620, Argentina
Sanatorio Cisma
San Miguel de Tucumán, T4000, Argentina
Hospital Privado de Rosario
Santa Fe, S2000GAP, Argentina
Canberra Hospital
Garran, Australian Capital Territory, 2605, Australia
Bankstown Hospital
Bankstown, New South Wales, 2200, Australia
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
John Hunter Hospital
Newcastle, New South Wales, 2305, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Sunshine Coast Hospital and Health Service
Birtinya, Queensland, 4575, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029, Australia
Redcliffe Hospital
Redcliffe, Queensland, 4020, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
Northeast Health Wangaratta
Wangaratta, Victoria, 3677, Australia
Royal Perth Hospital
Perth, Western Australia, 6000, Australia
Instituto do Coração do Hospital das Clínicas da FMUSP
Cerqueira César, 05403-900, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, 90035-903, Brazil
Foothills Hospital
Calgary, Alberta, T2N 2T9, Canada
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
Medicine Hat Regional Hospital
Medicine Hat, Alberta, T1A 4H6, Canada
East Kootenay Regional Hospital
Cranbrook, British Columbia, V1C 3H9, Canada
Fraser Health Authority
Surrey, British Columbia, V3V 1Z2, Canada
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1N1, Canada
Health Sciences Centre Winnipeg
Winnipeg, Manitoba, R3A 1R9, Canada
Dr.-Georges-L.-Dumont University Hospital Centre
Moncton, New Brunswick, E1C 2Z3, Canada
Halifax Infirmary
Halifax, Nova Scotia, B3H 3A6, Canada
Cape Breton University
Sydney, Nova Scotia, B1M 1A2, Canada
Cambridge Cardiac Care Centre
Cambridge, Ontario, N1R 6V6, Canada
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2, Canada
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6, Canada
Juravinski Hospital
Hamilton, Ontario, L8V 1C3, Canada
Kingston General Hospital
Kingston, Ontario, K7L 2V7, Canada
London Health Sciences Centre - University Hospital
London, Ontario, N6A 5A5, Canada
The Ottawa Hospital General Campus
Ottawa, Ontario, K1H 8L6, Canada
Niagara Health System - St. Catharine's Site
St. Catharines, Ontario, L2S 0A9, Canada
Cortelluci Vaughan Hospital
Vaughan, Ontario, L6A 4Z3, Canada
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 3E4, Canada
CHU de Quebec Universite Laval
Québec, Quebec, G1R 2J6, Canada
Hôpital Fleurimont du Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5H3, Canada
Regina General Hospital
Regina, Saskatchewan, S4P 0W5, Canada
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8, Canada
Aarhus University Hospital
Aarhus, 8200, Denmark
Hospital South West Jutland - University Hospital of Southern Denmark
Esbjerg, 6700, Denmark
Odense University Hospital
Odense, 5000, Denmark
Southwest Finland Wellbeing County (VARHA)
Turku, 20520, Finland
Universitatsklinikum Leipzig
Leipzig, 04103, Germany
GNRC Medical
North Guwāhāti, Assam, 781031, India
Marengo CIMS Hospital
Ahmedabad, Gujarat, 380060, India
NU Hospitals
Bangalore, Karnataka, 560010, India
Govt. T.D. Medical College
Alappuzha, Kerala, 688005, India
Amala Institute of Medical Sciences
Thrissur, Kerala, 680555, India
Amala Institute
Thrissur, Kerala, 680555, India
St. John's Medical College Hospital
Bangalore, 560034, India
JIPMER
Puducherry, 605006, India
Ruby Hall Clinic
Pune, 411057, India
Trivandrum Medical
Thiruvananthapuram, 695011, India
ASST Grande Ospedale Metropolitano Niguarda
Milan, Milan, 20162, Italy
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo
Alessandria, 15121, Italy
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
La Maddalena
Palermo, 90146, Italy
Piacenza Ospedale
Piacenza, 29121, Italy
Nobel Medical College Teaching Hospital
Biratnagar, 56700, Nepal
B.P. Koirala Institute of Health Sciences
Koshi, 56700, Nepal
B and B Hospital
Lalitpur, 44700, Nepal
Jeroen Bosch Hospital
's-Hertogenbosch, 5223, Netherlands
Noordwest Ziekenhuisgroep
Alkmaar, 1815, Netherlands
ZiekenhuisGroepTwente (ZGT)
Almelo, 7609, Netherlands
Ziekenhuis Amstelland
Amstelveen, 1186, Netherlands
Rijnstate Hospital
Arnhem, 6815, Netherlands
Amphia Ziekenhuis Breda
Breda, 4818 CK, Netherlands
Deventer Ziekenhuis
Deventer, 7416, Netherlands
Hospital Gelderse Vallei
Ede, 6716, Netherlands
Martini Hospital
Groningen, 9728, Netherlands
Franciscus Gasthuis
Rotterdam, 3045, Netherlands
Ikazia Hospital
Rotterdam, 3083, Netherlands
ETZ Tilburg
Tilburg, 5022, Netherlands
Aga Khan University
Karachi, Sindh, 74000, Pakistan
Maroof International Hospital
Islamabad, 04412, Pakistan
Shifa International Hospital
Islamabad, Pakistan
Dow Medical University
Karachi, Pakistan
Rehman Medical Institute
Peshawar, 25000, Pakistan
Korea Univesrity Anam Hospital
Seoul, 02841, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Seoul National University Bundang Hospital
Seoul, 13620, South Korea
Hospital de Mar
Barcelona, Barcelona, 08003, Spain
Vall d'Hebron Hospital
Barcelona, Barcelona, 08014, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025, Spain
Hospital Mutua de Terrassa
Barcelona, 08221, Spain
University Hospital Ramon y Cajal
Madrid, 28034, Spain
Hospital Universitario de Navarra
Pamplona, 31008, Spain
Karolinska Institutet Danderyd Hospital
Danderyd, 18257, Sweden
Uppsala University
Uppsala, 751 85, Sweden
University Hospital Basel
Basel, Basel, 4031, Switzerland
Kantonsspital St. Gallen
Sankt Gallen, 9000, Switzerland
Kantonsspital Winterthur
Winterthur, 8400, Switzerland
Liverpool Heart and Chest Hospital
Liverpool, L14 3PE, United Kingdom
Southend Hospital
Westcliff-on-Sea, SS0 0RY, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Conen, MD, MPH
Population Health Research Institute
- STUDY CHAIR
PJ Devereaux, MD, PhD
Population Health Research Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2019
First Posted
May 30, 2019
Study Start
June 14, 2019
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
January 12, 2026
Record last verified: 2026-01