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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

Non-operative atrial fibrillation (AF) is a major risk factor for the occurrence of death, stroke, congestive heart failure and cognitive dysfunction. Much less is known about perioperative AF. While perioperative AF may be a time-limited phenomenon due to perioperative stress or inflammation, affected patients do have an increased risk of stroke and death in the first month after surgery.

The benefits of oral anticoagulation seen in patients with non-operative AF suggests that oral anticoagulation may also be beneficial in patients with perioperative AF. However, it is unclear whether the stroke mechanisms are the same in patients with perioperative AF compared with non-operative 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 (NOACs) versus no OAC in patients with perioperative atrial fibrillation after noncardiac surgery and additional stroke risk factors.

Number of Patients

100

Number of Sites

5

Number of Countries

2

Study Period

2019-2021

Principal Investigator

David Conen; PJ Devereaux

Program Manager

Jessica Vincent

Research Coordinator

Rosemary Howe