NCT03968393

Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Atrial Fibrillation Occurring Transiently With Stress (ASPIRE-AF)

Keywords:

Atrial fibrillation

Stroke

Brief 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.

Detailed 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 duration of follow-up.

Intervention / Treatment

01

Non-vitamin K oral anticoagulant (NOAC)

Drug

Study Design

Primary Purpose

Prevention

Allocation

Randomized

Interventional Model

Parallel Assignment

Interventional Model Description

Prospective, randomized, open-label clinical trial with blinded outcome assessment

Masking

Single (Outcomes Assessor)

Arm Groups

Experimental: Non-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, 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.

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.

Eligibility Criteria

Any cardiac diagnosis as the primary reason for hospital admission;

History of documented chronic 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 (CrCl <20 ml/min);

Severe liver cirrhosis (i.e., Child-Pugh Class C)

Acute stroke in the past 14 days;

Undertook cardiac surgery in the past 35 days;

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

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;

Sinus rhythm at the time of randomization;

Any of the following high-risk criteria:
1. Age 55-64 years, and having either known cardiovascular disease, recent major vascular surgery, a CHA2DS2VASc score ≥3, or an elevated postoperative troponin level;
2. Age 65-74 years, and having either known cardiovascular disease, recent major vascular surgery, a CHA2DS2VASc score ≥2, or an elevated postoperative troponin level; OR
3. Age ≥75 years.;

Provide written informed consent