Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Perioperative Atrial Fibrillation After Noncardiac Surgery

• Status: Recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Pilot 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: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McMaster University; Population Health Research Institute
• Collaborators: Hamilton Health Sciences Corporation; Population Health Research Institute
• Treatments: Anticoagulants; Apixaban; Dabigatran; Edoxaban; Rivaroxaban

Criteria

Inclusion Criteria:

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

2. ≥1 episode of clinically significant perioperative AF;

3. sinus rhythm at the time of randomization; AND

4. any of the following high-risk criteria:

1. age ≥55 years, and having either known cardiovascular disease, recent major vascular surgery, or a CHA2DS2VASc score ≥3;

2. age ≥65 and a CHA2DS2VASc score**** ≥2; OR

3. 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 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; OR

13. previously enrolled in the trial