Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Perioperative AF After Noncardiac Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Stroke, Atrial Fibrillation

Intervention / Treatment
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* Drug: Non-vitamin K oral anticoagulant (NOAC)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized, open-label clinical trial with blinded outcome assessment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-vitamin K oral anticoagulant (NOAC)<br>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)<br>* 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.<br>* Other names: Rivaroxaban;|
| No Intervention: No anticoagulation<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Non-hemorrhagic stroke or systemic embolism |  | 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 |  | Up to 24 months, until final follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of vascular mortality |  | Up to 24 months, until final follow-up | 
| Incidence of non-fatal, non-hemorrhagic stroke |  | Up to 24 months, until final follow-up | 
| Incidence of Myocardial infarction |  | Up to 24 months, until final follow-up | 
| Incidence of peripheral arterial thrombosis |  | Up to 24 months, until final follow-up | 
| Incidence of amputation |  | Up to 24 months, until final follow-up | 
| Incidence of symptomatic venous thromboembolism |  | Up to 24 months, until final follow-up | 
| Incidence of all-cause stroke |  | Up to 24 months, until final follow-up | 
| Incidence of all-cause mortality |  | Up to 24 months, until final follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transient Atrial Fibrillation, Perioperative Atrial Fibrillation, Non-vitamin K Oral Anticoagulation, Noncardiac Surgery, PROBE Design