Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Perioperative Atrial Fibrillation After Noncardiac Surgery (ASPIRE-AF)
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ClinicalTrials.gov Identifier: NCT03968393 |
Recruitment Status :
Recruiting
First Posted : May 30, 2019
Last Update Posted : March 29, 2022
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Condition or disease | Intervention/treatment | Phase |
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Stroke Atrial Fibrillation | Drug: Investigators can choose from one of four Non-vitamin K oral anticoagulants (NOACs): Edoxaban 60mg daily, Apixaban 5mg twice daily, Dabigatran 110mg twice daily, or, Rivaroxaban 20mg daily. | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 2800 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Prospective, randomized, open-label clinical trial with blinded outcome assessment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Perioperative Atrial Fibrillation After Noncardiac Surgery - The ASPIRE-AF Pilot Study |
Actual Study Start Date : | June 14, 2019 |
Estimated Primary Completion Date : | September 2026 |
Estimated Study Completion Date : | December 2026 |

Arm | Intervention/treatment |
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Experimental: Non-vitamin K oral anticoagulant (NOAC)
Patients allocated to the NOAC arm will receive oral anticoagulation for 24 months, unless the patient is discontinued for procedures with increased risk of bleeding, adverse events, low creatinine clearance, or patient decision.
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Drug: Investigators can choose from one of four Non-vitamin K oral anticoagulants (NOACs): Edoxaban 60mg daily, Apixaban 5mg twice daily, Dabigatran 110mg twice daily, or, Rivaroxaban 20mg daily.
Daily administration from time of randomization to final follow-up |
No Intervention: No anticoagulation
Patients allocated to the no anticoagulation arm are not allowed to receive oral anticoagulation, unless the patient develops an indication for its use during follow-up.
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- Incidence of Non-hemorrhagic stroke or systemic embolism [ Time Frame: Up to 24 months, until final follow-up ]
- Incidence of vascular mortality, and non-fatal non-hemorrhagic stroke, myocardial infarction, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism [ Time Frame: Up to 24 months, until final follow-up ]
- Incidence of vascular mortality [ Time Frame: Up to 24 months, until final follow-up ]
- Incidence of non-fatal, non-hemorrhagic stroke [ Time Frame: Up to 24 months, until final follow-up ]
- Incidence of Myocardial infarction [ Time Frame: Up to 24 months, until final follow-up ]
- Incidence of peripheral arterial thrombosis [ Time Frame: Up to 24 months, until final follow-up ]
- Incidence of amputation [ Time Frame: Up to 24 months, until final follow-up ]
- Incidence of symptomatic venous thromboembolism [ Time Frame: Up to 24 months, until final follow-up ]
- Incidence of all-cause stroke [ Time Frame: Up to 24 months, until final follow-up ]
- Incidence of all-cause mortality [ Time Frame: Up to 24 months, until final follow-up ]
- Safety objective: incidence of composite of life-threatening, major, and critical organ bleeding [ Time Frame: Up to 24 months, until final follow-up ]as previously used in the MANAGE trial
- Safety objective: incidence of major bleeding [ Time Frame: Up to 24 months, until final follow-up ]According to the ISTH criteria
- Safety objective: incidence of hemorrhagic stroke [ Time Frame: Up to 24 months, until final follow-up ]
- Tertiary objective: hospitalization for vascular causes [ Time Frame: Up to 24 months, until final follow-up ]
- Tertiary objective: hospitalization for all causes [ Time Frame: Up to 24 months, until final follow-up ]

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Ages Eligible for Study: | 55 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03968393
Contact: Jennifer Wells | 905-297-3479 ext 41133 | aspireaf@phri.ca |
Canada, Alberta | |
University of Alberta Hospital | Active, not recruiting |
Edmonton, Alberta, Canada, T6G 2B7 | |
Canada, Ontario | |
Hamilton General Hospital | Recruiting |
Hamilton, Ontario, Canada, L8L 2X2 | |
Principal Investigator: Mohamed Panju, MD | |
St. Joseph's Healthcare Hamilton | Recruiting |
Hamilton, Ontario, Canada, L8N 4A6 | |
Principal Investigator: Vikas Tandon, MD | |
Juravinski Hospital | Recruiting |
Hamilton, Ontario, Canada, L8V 1C3 | |
Principal Investigator: Ameen Patel, MD | |
Kingston General Hospital | Recruiting |
Kingston, Ontario, Canada, K7L 2V7 | |
Principal Investigator: Michael McMullen, MD | |
University Hospital | Active, not recruiting |
London, Ontario, Canada, N6A 5A5 | |
The Ottawa Hospital General Campus | Recruiting |
Ottawa, Ontario, Canada, K1H 8L6 | |
Principal Investigator: James Villeneuve, MD | |
St. Catharines Site - Niagara Health System | Recruiting |
St. Catharines, Ontario, Canada, L2S 0A9 | |
Principal Investigator: Natalia Pinilla-Echeverri, MD | |
Canada, Quebec | |
Centre hospitalier de l'Université de Montréal | Recruiting |
Montréal, Quebec, Canada, H2X 3E4 | |
Principal Investigator: Isabelle Greiss, MD | |
Canada | |
Halifax Infirmary | Recruiting |
Halifax, Canada | |
Principal Investigator: Kim Styles, MD | |
Denmark | |
Odense University Hospital | Recruiting |
Odense, Denmark, 5000 | |
Principal Investigator: Axel Brandes, MD |
Principal Investigator: | David Conen, MD, MPH | Population Health Research Institute | |
Study Chair: | PJ Devereaux, MD, PhD | Population Health Research Institute |
Responsible Party: | Population Health Research Institute |
ClinicalTrials.gov Identifier: | NCT03968393 |
Other Study ID Numbers: |
2019-ASPIREAF 2019-001336-62 ( EudraCT Number ) |
First Posted: | May 30, 2019 Key Record Dates |
Last Update Posted: | March 29, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Transient Atrial Fibrillation Perioperative Atrial Fibrillation Non-vitamin K Oral Anticoagulation Noncardiac Surgery PROBE Design |
Stroke Atrial Fibrillation Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Arrhythmias, Cardiac Heart Diseases Pathologic Processes |
Rivaroxaban Apixaban Edoxaban Dabigatran Anticoagulants Factor Xa Inhibitors Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |