Multinational, investigator-initiated study of oral anticoagulation versus no anticoagulation for the prevention of stroke and other adverse cardiovascular events in patients with transient perioperative atrial fibrillation after noncardiac surgery and additional stroke risk factors.

Phase 4

• Conditions: Health Condition 1: I48- Atrial fibrillation and flutterHealth Condition 2: I63- Cerebral infarction

• Registration Number: CTRI/2023/01/049006
• Lead Sponsor: Population Health Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.noncardiac surgery with at least an overnight hospital admission after surgery in the last 35 days;

2.=1 episode of clinically important perioperative AF during or after their surgery;

3.sinus rhythm at the time of randomization; AND

4.any of the following high-risk criteria:

a.age 55-74 years, and having either known cardiovascular disease, recent major vascular surgery, or a CHA2DS2VASc score =3;OR

b.age =75 years.

Exclusion Criteria

1.history of documented AF prior to noncardiac surgery;

2.need for long-term systemic anticoagulation;

3.ongoing need for long-term dual antiplatelet treatment;

4.contraindication to oral anticoagulation;

5.severe renal insufficiency (eGFR <30 ml/min);

6.acute stroke in the past 3 months;

7.underwent cardiac surgery in the past 3 months;

8.history of nontraumatic intracranial, intraocular, or spinal bleeding;

9.hemorrhagic disorder or bleeding diathesis;

10.expected to be non-compliant with follow-up and/or study medications;

11.known life expectancy less than 1 year due to concomitant disease;

12.women who are pregnant, breastfeeding, or of childbearing potential who are not taking effective contraception; OR

13.previously enrolled in the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Incidence of Non-hemorrhagic stroke or systemic embolism <br/ ><br>2.Incidence of vascular mortality, and non-fatal non-hemorrhagic stroke, myocardial infarction, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolismTimepoint: Up to 24 months, until final follow-up

Secondary Outcome Measures

Name	Time	Method
1.Incidence of vascular mortality <br/ ><br>2.Incidence of non-fatal, non-hemorrhagic stroke <br/ ><br>3.Incidence of Myocardial infarction <br/ ><br>4.Incidence of peripheral arterial thrombosis <br/ ><br>5.Incidence of amputation <br/ ><br>6.Incidence of symptomatic venous thromboembolism <br/ ><br>7.Incidence of all-cause stroke <br/ ><br>8.Incidence of all-cause mortality <br/ ><br>Timepoint: Up to 24 months, until final follow-up