Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Perioperative Atrial Fibrillation After Noncardiac Surgery - The ASPIRE-AF Trial (ASPIRE-AF)

  • STATUS
    Recruiting
  • End date
    Dec 16, 2026
  • participants needed
    2800
  • sponsor
    Population Health Research Institute
Updated on 16 October 2022
stroke
anticoagulants
atrial fibrillation
rivaroxaban
fibrillation
noac
vitamin k
apixaban
edoxaban
dabigatran
anticoagulation therapy

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.

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 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 24 months after randomization.

Details
Condition Stroke, Atrial Fibrillation
Treatment 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., Non-vitamin K oral anticoagulant (NOAC)
Clinical Study IdentifierNCT03968393
SponsorPopulation Health Research Institute
Last Modified on16 October 2022

Eligibility

Yes No Not Sure

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
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