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Research

Photo for ASPIRE-AF

ASPIRE-AF

Official Title

Anticoagulation for stroke prevention in patients with a recent event of perioperative atrial fibrillation after noncardiac surgery

Status

Ongoing

Overview

Much less is known about perioperative atrial fibrillation (AF) than about is known about clinical AF. While perioperative AF may be a time-limited phenomenon due to perioperative stress and inflammation, affected patients do have an increased risk of stroke and death in the first month after surgery. patients with perioperative AF have a poor long-term outcome, and given the benefits of oral anticoagulation in clinical AF suggest that oral anticoagulation may be beneficial in patients with perioperative AF. It is, however, unclear whether the stroke mechanisms are the same in patients with perioperative AF compared to patients with clinical AF.

Moreover, postoperative patients have an increased risk of bleeding, and the benefit-risk balance of anticoagulation in this patient population is unknown. On the other hand, oral anticoagulation in high-risk postoperative patients may help to prevent other thrombotic events and thus confer additional benefits.

Study Design

Prospective, randomized, open-label clinical trial with blinded outcome assessment (PROBE design)

Primary Endpoint

To assess the feasibility of a randomized controlled trial of non-vitamin K oral anticoagulants versus usual care in patients with perioperative atrial fibrillation (AF) after noncardiac surgery and additional stroke risk factors.

Number of Patients

100

Number of Sites

4

Number of Countries

1

Study Period

2019-2021

Principal Investigator

David Conen, PJ Devereaux, Emmanuelle Duceppe

Program Manager

Shirley Pettit

Research Coordinator

Rosemary Howe