Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Atrial Fibrillation Occurring Transiently With Stress - The ASPIRE-AF Trial
Population Health Research Institute
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 atrial fibrillation occurring transiently with stress 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 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 dura…
Eligibility
- Age range
- 55+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugNon-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.
Locations (105)
- Cedars-Sinai Medical CenterLos Angeles, California
- Mcgovern Medical School at University of TexasHouston, Texas
- Clinica Coronel SuarezCoronel Suárez, Buenos Aires
- Instituto de Investigaciones Clinicas RosarioRosario, Santa Fe Province
- Instituto Cardiovascular de RosarioRosario, Santa Fe Province
- Centro Integral de Arritmias de Tucuman (CIAT)San Miguel de Tucumán, Tucumán Province