Anticoagulation for Stroke Prevention In patients with Recent Episodes of perioperative Atrial Fibrillation after noncardiac surgery - The ASPIRE-AF trial - 2019-ASPIREAF

Hamilton Health Sciences Corporation0 sites2,270 target enrollmentDecember 5, 2023

Overview

No summary available.

Registry

who.int

Start Date

December 5, 2023

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Have had noncardiac surgery in the past 35 days, with at least one of the following: (1\) at least an overnight hospital admission after surgery; or (2\) day surgery resulting in a large enough physiological insult to be able to cause perioperative AF, as judged by the local investigator, Have had \= one episode of clinically important perioperative AF during or after their surgery, Are in sinus rhythm at the time of randomization, Meet any of the following high\-risk criteria; (1\) age 55\-64 years, and having either established cardiovascular disease, recent major vascular surgery, a CHA2DS2VASc score \= 3, or an elevated postoperative troponin level; (2\) age 65\-74 years, and having either established cardiovascular disease, recent vascular surgery, a CHA2DS2VASc score \= 2, or an elevated postoperative troponin level; or (3\) age \= 75 years, Provide written informed consent to participate

•Have a history of documented chronic (i.e., non\-transient) AF prior to noncardiac surgery. For example, the following patients will still be considered eligible for this trial: (1\) a history of subclinical AF only (i.e., AF episodes only documented by pacemakers or similar devices); (2\) a previous history of perioperative AF only (after cardiac or noncardiac surgery); or (3\) patients with a previous history of transient AF after medical stress (e.g., sepsis, uncontrolled hyperthyroidism), Have had cardiac surgery in the past 35 days, Have a history of nontraumatic intracranial, intraocular, or spinal bleeding, Are expected to be non\-compliant with follow\-up and/or study medications, Have severe liver cirrhosis (i.e., Child\-Pugh Class C), Have a known life expectancy less than one year due to concomitant disease, Are women who are pregnant, breastfeeding, or of childbearing potential who are not taking effective contraception, Were previously enrolled in the trial, Need for long\-term systemic anticoagulation (e.g., pre\-existing AF, mechanical heart valve, antiphospholipid syndrome with a history of thrombosis)), Have an ongoing need for long\-term dual antiplatelet treatment, Have a contraindication to oral anticoagulation, Have severe renal insufficiency (CrCl \< 20 ml/min), Have had an acute stroke in the past 14 days