Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Atrial Fibrillation Occurring Transiently With Stress (ASPIRE-AF)

Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Atrial Fibrillation Occurring Transiently With Stress - The ASPIRE-AF Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Atrial Fibrillation
• Intervention / Treatment: Drug: Non-vitamin K oral anticoagulant (NOAC)

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 atrial fibrillation and additional stroke factors occurring transiently with stress. 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.

• Study Type: Interventional
• Enrollment (Estimated): 2270
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Cassie McDonald; Phone Number: 1-905-594-0560; Email: aspireaf@phri.ca

Study Locations

• Argentina
  • Chivilcoy, Argentina, B6620
    • Recruiting
    • Hospital Municipal Chivilcoy
    • Principal Investigator: Pablo Fernandez, MD
  • San Miguel de Tucumán, Argentina, T4000
    • Recruiting
    • Sanatorio Cisma
    • Principal Investigator: Guillermo Isa Messa, MD
  • Santa Fe, Argentina, S2000GAP
    • Not yet recruiting
    • Hospital Privado de Rosario
    • Principal Investigator: Carlos Dumont, MD
  • Buenos Aires
    • Coronel Suárez, Buenos Aires, Argentina, 7540
      • Recruiting
      • Clinica Coronel Suárez
      • Principal Investigator: Alberto Caccavo, MD
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, 2000
      • Recruiting
      • Instituto de Investigaciones Clinicas Rosario
      • Principal Investigator: Mariela Rasmussen, MD
    • Rosario, Santa Fe Province, Argentina, S2000
      • Recruiting
      • Instituto Cardiovascular de Rosario
      • Principal Investigator: Alejandro Meirino, MD
  • Tucumán Province
    • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
      • Recruiting
      • Centro Integral de Arritmias de Tucuman (CIAT)
      • Principal Investigator: Maria Cecilia Moris, MD
• Australia
  • Australian Capital Territory
    • Garran, Australian Capital Territory, Australia, 2605
      • Recruiting
      • Canberra Hospital
      • Principal Investigator: Walter Abhayaratna, MD
  • New South Wales
    • Bankstown, New South Wales, Australia, 2200
      • Recruiting
      • Bankstown Hospital
      • Principal Investigator: Jens Killian, MD
    • Camperdown, New South Wales, Australia, 2050
      • Recruiting
      • Royal Prince Alfred Hospital
      • Principal Investigator: Sanjay Patel, MD
    • Concord, New South Wales, Australia, 2139
      • Recruiting
      • Concord Repatriation General Hospital
      • Principal Investigator: David Brieger, MD
    • Liverpool, New South Wales, Australia, 2170
      • Not yet recruiting
      • Liverpool Hospital
      • Principal Investigator: John French, MD
    • Newcastle, New South Wales, Australia, 2305
      • Recruiting
      • John Hunter Hospital
      • Principal Investigator: Aaron Sverdlov, MD
    • Westmead, New South Wales, Australia, 2145
      • Recruiting
      • Westmead Hospital
      • Principal Investigator: Clara Chow, MD
  • Queensland
    • Birtinya, Queensland, Australia, 4575
      • Recruiting
      • Sunshine Coast Hospital and Health Service
      • Principal Investigator: Nicholas New, MD
    • Herston, Queensland, Australia, 4029
      • Not yet recruiting
      • Royal Brisbane and Women's Hospital
      • Principal Investigator: John Atherton, MD
    • Redcliffe, Queensland, Australia, 4020
      • Recruiting
      • Redcliffe Hospital
      • Principal Investigator: Patrick Carroll, MD
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Not yet recruiting
      • Royal Adelaide Hospital
      • Principal Investigator: Peter Psaltis, MD
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Recruiting
      • Box Hill Hospital
      • Principal Investigator: Jaya Chandrasekhar, MD
    • Wangaratta, Victoria, Australia, 3677
      • Recruiting
      • Northeast Health Wangaratta
      • Principal Investigator: Anthony Baird, MD
  • Western Australia
    • Perth, Western Australia, Australia, 6000
      • Recruiting
      • Royal Perth Hospital
      • Principal Investigator: Graham Hillis, MD
• Brazil
  • Cerqueira César, Brazil, 05403-900
    • Recruiting
    • Instituto do Coração do Hospital das Clínicas da FMUSP
    • Principal Investigator: Carlos Serrano, MD
  • Porto Alegre, Brazil, 90035-903
    • Recruiting
    • Hospital de Clínicas de Porto Alegre
    • Principal Investigator: Carisi Polanczyk, MD
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Recruiting
      • Foothills Hospital
      • Principal Investigator: Shannon Ruzycki, MD
    • Edmonton, Alberta, Canada, T6G 2B7
      • Recruiting
      • University of Alberta Hospital
      • Principal Investigator: Finlay McAlister, MD
    • Medicine Hat, Alberta, Canada, T1A 4H6
      • Recruiting
      • Medicine Hat Regional Hospital
      • Principal Investigator: Herbert Manosalva, MD
  • British Columbia
    • Cranbrook, British Columbia, Canada, V1C 3H9
      • Not yet recruiting
      • East Kootenay Regional Hospital
      • Principal Investigator: Denise Jaworsky, MD
    • Surrey, British Columbia, Canada, V3V 1Z2
      • Recruiting
      • Fraser Health Authority
      • Principal Investigator: Mark Warwas, MD
    • Vancouver, British Columbia, Canada, V5Z 1N1
      • Recruiting
      • Vancouver General Hospital
      • Principal Investigator: Mihalio Veljovic, MD
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1R9
      • Recruiting
      • Health Sciences Centre Winnipeg
      • Principal Investigator: Sadeesh Srinathan, MD
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 2Z3
      • Not yet recruiting
      • Dr.-Georges-L.-Dumont University Hospital Centre
      • Principal Investigator: Remi LeBlanc, MD
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 3A6
      • Recruiting
      • Halifax Infirmary
      • Principal Investigator: Kim Styles, MD
    • Sydney, Nova Scotia, Canada, B1M 1A2
      • Recruiting
      • Cape Breton University
      • Principal Investigator: Paul MacDonald, MD
  • Ontario
    • Cambridge, Ontario, Canada, N1R 6V6
      • Not yet recruiting
      • Cambridge Cardiac Care Centre
      • Principal Investigator: A. Shekhar Pandey, MD
    • Hamilton, Ontario, Canada, L8L 2X2
      • Recruiting
      • Hamilton General Hospital
      • Principal Investigator: Mohamed Panju, MD
    • Hamilton, Ontario, Canada, L8N 4A6
      • Recruiting
      • St. Joseph's Healthcare Hamilton
      • Principal Investigator: Vikas Tandon, MD
    • Hamilton, Ontario, Canada, L8V 1C3
      • Recruiting
      • Juravinski Hospital
      • Principal Investigator: Ameen Patel, MD
    • Kingston, Ontario, Canada, K7L 2V7
      • Recruiting
      • Kingston General Hospital
      • Principal Investigator: Stephanie Sibley, MD
    • London, Ontario, Canada, N6A 5A5
      • Recruiting
      • London Health Sciences Centre - University Hospital
      • Principal Investigator: Marko Mrkobrada, MD
    • Ottawa, Ontario, Canada, K1H 8L6
      • Recruiting
      • The Ottawa Hospital General Campus
      • Principal Investigator: James Villeneuve, MD
    • St. Catharines, Ontario, Canada, L2S 0A9
      • Recruiting
      • Niagara Health System - St. Catharine's Site
      • Principal Investigator: Leonard Blair, MD
    • Vaughan, Ontario, Canada, L6A 4Z3
      • Recruiting
      • Cortelluci Vaughan Hospital
      • Principal Investigator: Courtney Anne Scott, MD
  • Quebec
    • Montreal, Quebec, Canada, H2X 3E4
      • Recruiting
      • Centre Hospitalier de l'Université de Montréal
      • Principal Investigator: Isabelle Greiss, MD
    • Québec, Quebec, Canada, G1R 2J6
      • Not yet recruiting
      • CHU de Quebec Universite Laval
      • Principal Investigator: Sebastien Joncas, MD
    • Sherbrooke, Quebec, Canada, J1H 5H3
      • Recruiting
      • Hôpital Fleurimont du Centre hospitalier universitaire de Sherbrooke
      • Principal Investigator: Felix Ayala-Paredes, MD
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4P 0W5
      • Recruiting
      • Regina General Hospital
      • Principal Investigator: Payam Dehghani, MD
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • Recruiting
      • Royal University Hospital
      • Principal Investigator: Michael Prystajecky, MD
• Denmark
  • Aarhus, Denmark, 8200
    • Recruiting
    • Aarhus University Hospital
    • Principal Investigator: Erik Grove, MD
  • Esbjerg, Denmark, 6700
    • Recruiting
    • Hospital South West Jutland - University Hospital of Southern Denmark
    • Principal Investigator: Axel Brandes, MD
  • Odense, Denmark, 5000
    • Recruiting
    • Odense University Hospital
    • Principal Investigator: Axel Brandes, MD
• Finland
  • Turku, Finland, 20520
    • Recruiting
    • Southwest Finland Wellbeing County (VARHA)
    • Principal Investigator: Tuomas Kiviniemi, MD
• Germany
  • Leipzig, Germany, 04103
    • Recruiting
    • Universitatsklinikum Leipzig
    • Principal Investigator: Rolf Wachter, MD
• India
  • Bangalore, India, 560034
    • Recruiting
    • St. John's Medical College Hospital
    • Principal Investigator: Joe Cherian, MD
  • Puducherry, India, 605006
    • Recruiting
    • JIPMER
    • Principal Investigator: Adinarayanan Sethurmachandran, MD
  • Pune, India, 411057
    • Not yet recruiting
    • Ruby Hall Clinic
    • Principal Investigator: Jagdish Hiremath, MD
  • Thiruvananthapuram, India, 695011
    • Recruiting
    • Trivandrum Medical
    • Principal Investigator: Prem Menon, MD
  • Assam
    • North Guwāhāti, Assam, India, 781031
      • Not yet recruiting
      • GNRC Medical
      • Principal Investigator: Krishna Chaudra Narczarcy, MD
  • Gujarat
    • Ahmedabad, Gujarat, India, 380060
      • Not yet recruiting
      • Marengo Cims Hospital
      • Principal Investigator: Ajay Naik, MD
  • Karnataka
    • Bangalore, Karnataka, India, 560010
      • Recruiting
      • NU Hospitals
      • Principal Investigator: Pramod Krishnappa, MD
  • Kerala
    • Alappuzha, Kerala, India, 688005
      • Not yet recruiting
      • Govt. T.D. Medical College
      • Principal Investigator: Sajikumar Raghavan, MD
    • Thrissur, Kerala, India, 680555
      • Not yet recruiting
      • Amala Institute
      • Principal Investigator: Kishore Puthezhath, MD
    • Thrissur, Kerala, India, 680555
      • Recruiting
      • Amala Institute of Medical Sciences
      • Principal Investigator: Rupesh George, MD
• Italy
  • Alessandria, Italy, 15121
    • Recruiting
    • Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo
    • Principal Investigator: Ferruccio Ravazzoni, MD
  • Milan, Italy, 20122
    • Recruiting
    • Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
    • Principal Investigator: Giuseppe Ristagno, MD
  • Palermo, Italy, 90146
    • Recruiting
    • La Maddalena
    • Principal Investigator: Salvatore D'Arpa, MD
  • Piacenza, Italy, 29121
    • Recruiting
    • Piacenza Ospedale
    • Principal Investigator: Maria Bolognesi, MD
  • Milan
    • Milan, Milan, Italy, 20162
      • Recruiting
      • ASST Grande Ospedale Metropolitano Niguarda
      • Principal Investigator: Matteo Baroni, MD
• Nepal
  • Biratnagar, Nepal, 56700
    • Recruiting
    • Nobel Medical College Teaching Hospital
    • Principal Investigator: Rajesh Nepal, MD
  • Koshi, Nepal, 56700
    • Recruiting
    • B.P. Koirala Institute of Health Sciences
    • Principal Investigator: Sanjib Sharma, MD
  • Lalitpur, Nepal, 44700
    • Recruiting
    • B and B Hospital
    • Principal Investigator: Rajib Rajbhandari, MD
• Netherlands
  • 's-Hertogenbosch, Netherlands, 5223
    • Recruiting
    • Jeroen Bosch Hospital
    • Principal Investigator: Jacob Van Eck, MD
  • Alkmaar, Netherlands, 1815
    • Recruiting
    • Noordwest ziekenhuisgroep
    • Principal Investigator: Stefan Timmer, MD
  • Almelo, Netherlands, 7609
    • Recruiting
    • ZiekenhuisGroepTwente (ZGT)
    • Principal Investigator: Lambertus Pos, MD
  • Amstelveen, Netherlands, 1186
    • Recruiting
    • Ziekenhuis Amstelland
    • Principal Investigator: Freerk Broeyer, MD
  • Arnhem, Netherlands, 6815
    • Recruiting
    • Rijnstate Hospital
    • Principal Investigator: Ron Pisters, MD
  • Breda, Netherlands, 4818 CK
    • Recruiting
    • Amphia Ziekenhuis Breda
    • Principal Investigator: Marco Alings, MD
  • Deventer, Netherlands, 7416
    • Recruiting
    • Deventer Ziekenhuis
    • Principal Investigator: Ype Tuininga, MD
  • Ede, Netherlands, 6716
    • Recruiting
    • Hospital Gelderse Vallei
    • Principal Investigator: Thomas Oosterhof, MD
  • Groningen, Netherlands, 9728
    • Recruiting
    • Martini Hospital
    • Principal Investigator: Robert Tieleman, MD
  • Rotterdam, Netherlands, 3083
    • Recruiting
    • Ikazia Hospital
    • Principal Investigator: Stieneke Zoet-Nugteren, MD
  • Rotterdam, Netherlands, 3045
    • Recruiting
    • Franciscus Gasthuis
    • Principal Investigator: Peter Nierop, MD
  • Tilburg, Netherlands, 5022
    • Recruiting
    • ETZ Tilburg
    • Principal Investigator: Walter Hermans, MD
• Pakistan
  • Islamabad, Pakistan
    • Recruiting
    • Shifa International Hospital
    • Principal Investigator: Saeed Ullah Shah, MD
  • Islamabad, Pakistan, 04412
    • Recruiting
    • Maroof International Hospital
    • Principal Investigator: Mir Abdul Waheed, MD
  • Karachi, Pakistan
    • Recruiting
    • Dow Medical University
    • Principal Investigator: Muhammad Tariq Farman, MD
  • Peshawar, Pakistan, 25000
    • Recruiting
    • Rehman Medical Institute
    • Principal Investigator: Azam Jan, MD
  • Sindh
    • Karachi, Sindh, Pakistan, 74000
      • Recruiting
      • Aga Khan University
      • Principal Investigator: Yawer Saeed, MD
• South Korea
  • Seoul, South Korea, 03080
    • Recruiting
    • Seoul National University Hospital
    • Principal Investigator: Eue-Keun Choi, MD
  • Seoul, South Korea, 13620
    • Recruiting
    • Seoul National University Bundang Hospital
    • Principal Investigator: Il-Young Oh, MD
  • Seoul, South Korea, 02841
    • Recruiting
    • Korea Univesrity Anam Hospital
    • Principal Investigator: Jong-Il Choi, MD
• Spain
  • Barcelona, Spain, 08025
    • Recruiting
    • Hospital De La Santa Creu I Sant Pau
    • Principal Investigator: Jose M Guerra, MD
  • Barcelona, Spain, 08221
    • Recruiting
    • Hospital Mútua de Terrassa
    • Principal Investigator: Beatriz Toledano Leon, MD
  • Madrid, Spain, 28034
    • Recruiting
    • University Hospital Ramón y Cajal
    • Principal Investigator: Jesus Alvarez Garcia, MD
  • Pamplona, Spain, 31008
    • Recruiting
    • Hospital Universitario de Navarra
    • Principal Investigator: Oscar Alcalde, MD
  • Barcelona
    • Barcelona, Barcelona, Spain, 08003
      • Not yet recruiting
      • Hospital de Mar
      • Principal Investigator: Sandra Beltran de Heredia Marrodan, MD
    • Barcelona, Barcelona, Spain, 08014
      • Not yet recruiting
      • Vall d'Hebron Hospital
      • Principal Investigator: Montserrat Ribas Ball, MD
• Sweden
  • Danderyd, Sweden, 18257
    • Recruiting
    • Karolinska Institutet Danderyd Hospital
    • Principal Investigator: Piotr Sobocinski-Doliwa, MD
  • Uppsala, Sweden, 751 85
    • Recruiting
    • Uppsala University
    • Principal Investigator: Claes Held, MD
    • Principal Investigator: Gorav Batra, MD
• Switzerland
  • Sankt Gallen, Switzerland, 9000
    • Recruiting
    • Kantonsspital St. Gallen
    • Principal Investigator: Timur Yurttas, MD
  • Winterthur, Switzerland, 8400
    • Recruiting
    • Kantonsspital Winterthur
    • Principal Investigator: Michael Osthoff, MD
  • Basel
    • Basel, Basel, Switzerland, 4031
      • Recruiting
      • University Hospital Basel
      • Principal Investigator: Philipp Krisai, MD
• United Kingdom
  • Liverpool, United Kingdom, L14 3PE
    • Recruiting
    • Liverpool Heart and Chest Hospital
    • Principal Investigator: Michael Shackcloth, MD
  • Westcliff-on-Sea, United Kingdom, SS0 0RY
    • Recruiting
    • Southend Hospital
    • Principal Investigator: James Jegard, MD
• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars-Sinai Medical Center
      • Principal Investigator: Eric Braunstein, MD
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Mcgovern Medical School at University of Texas
      • Principal Investigator: Sanjana Malviya, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No anticoagulation; 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.
Experimental: 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.	Drug: 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.; Other Names: Apixaban; Dabigatran; Edoxaban; Rivaroxaban

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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)
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 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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of composite of life-threatening, major, and critical organ bleeding	Safety objective, measured as previously done in the MANAGE trial	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	Safety objective, measured according to the ISTH criteria	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	Safety objective	For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
Hospitalization for vascular causes	Tertiary Objective	For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
Hospitalization for all causes	Tertiary Objective	For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)

Collaborators and Investigators

• Sponsor: Population Health Research Institute
• Collaborators: Hamilton Health Sciences Corporation
• Investigators: Principal Investigator: David Conen, MD, MPH, Population Health Research Institute; Study Chair: PJ Devereaux, MD, PhD, Population Health Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2019
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: March 22, 2019
• First Submitted That Met QC Criteria: May 27, 2019
• First Posted (Actual): May 30, 2019

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Stress; Transient Atrial Fibrillation; Perioperative Atrial Fibrillation; Non-vitamin K Oral Anticoagulation; Noncardiac Surgery; PROBE Design; Medical Illness
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Stroke; Atrial Fibrillation; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Morpholines; Oxazines; Thiophenes; Rivaroxaban; Dabigatran; apixaban; edoxaban
• Other Study ID Numbers: 2019-ASPIREAF; 2019-001336-62 (EudraCT Number); 2023-509142-35-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No