Anticoagulation for Stroke Prevention In patients with Recent Episodes of perioperative Atrial Fibrillation after noncardiac surgery

Phase 1

• Conditions: Perioperative atrial fibrillation after noncardiac surgery; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]; MedDRA version: 20.0Level: LLTClassification code: 10005103Term: Bleeding Class: 10047065; MedDRA version: 26.1Level: LLTClassification code: 10042244Term: Stroke Class: 10029205; MedDRA version: 20.0Level: LLTClassification code: 10003663Term: Atrial flutter/ fibrillation Class: 10007541

• Registration Number: CTIS2023-509142-35-00
• Lead Sponsor: Hamilton Health Sciences Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-05
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2270

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified