Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Perioperative Atrial Fibrillation After Noncardiac Surgery (ASPIRE-AF)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03968393 |
Recruitment Status :
Recruiting
First Posted : May 30, 2019
Last Update Posted : October 25, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Stroke Atrial Fibrillation | Drug: Non-vitamin K oral anticoagulant (NOAC) | 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 Trial |
Actual Study Start Date : | June 14, 2019 |
Estimated Primary Completion Date : | September 2026 |
Estimated Study Completion Date : | December 2026 |

Arm | Intervention/treatment |
---|---|
Experimental: Non-vitamin K oral anticoagulant (NOAC)
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.
|
Drug: Non-vitamin K oral anticoagulant (NOAC)
Participants randomized to the intervention arm will be prescribed one of the following NOACs for 24 months: 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. |
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.
|
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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
-
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 |

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: | October 25, 2022 |
Last Verified: | October 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 Anticoagulants |