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

Hamilton Health Sciences Corporation0 个研究点目标入组 2,800 人开始时间: 2019年11月18日最近更新: 2024年2月26日

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•Patients are eligible if they fulfill all of the following criteria:
•1. have had noncardiac surgery with at least an overnight hospital admission after surgery in the last 35 days;
•2. have had = one episode of clinically important perioperative AF during or after their surgery;
•3. are in sinus rhythm at the time of randomization;
•4. meet any of the following high-risk criteria; and
•o age 55-74 years, and having either known cardiovascular disease, recent major vascular surgery, or a CHA2DS2VASc score = 3; or
•o age = 75 years.
•5. provide written informed consent to participate
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 840
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1960

•Patients are excluded if they meet any of the following criteria:
•1. have a history of documented AF prior to noncardiac surgery; a history of subclinical AF only (i.e., AF episodes only documented by pacemakers or similar devices) or a previous history of perioperative AF only (after cardiac or noncardiac surgery) are not exclusion criteria;
•2. need for long-term systemic anticoagulation (e.g., pre-existing AF, mechanical heart valve);
•3. have an ongoing need for long-term dual antiplatelet treatment;
•4. have a contraindication to oral anticoagulation;
•5. have severe renal insufficiency (eGFR < 30 ml/min);
•6. have had an acute stroke in the past three months;
•6. have had cardiac surgery in the past three months;
•7. have a history of nontraumatic intracranial, intraocular, or spinal bleeding;
•8. have hemorrhagic disorder or bleeding diathesis;
•8. are expected to be non-compliant with follow-up and/or study medications;
•9. have a known life expectancy less than one year due to concomitant disease;
•10. are women who are pregnant, breastfeeding, or of childbearing potential who are not taking effective contraception; or
•11. were previously enrolled in the trial.

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