The Safety of Non-vitamin K Oral Anticoagulants Compared to Warfarin Early After Cardiac Surgery

• Status: Not yet recruiting
• Trial end date: 2022-11-30
• Target enrollment: 0
• Participant gender: All

Summary

A small pilot study comparing different blood thinners (non-vitamin K oral anticoagulants [NOACs] and warfarin) will be conducted in people at risk for blood clots after open-heart surgery. This study will help us design a much bigger study to test the effectiveness and safety of different blood thinners in people after open-heart surgery. The study will test the following hypotheses: (1) Our standardized use of different blood thinners is feasible in patients early after cardiac surgery. (2) NOACs are safe to use early after cardiac surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Paul's Hospital, Canada
• Treatments: Anticoagulants; Apixaban; Dabigatran; Edoxaban; Rivaroxaban; Warfarin

Criteria

Inclusion Criteria:

1. Adults ≥18 years

2. Cardiac surgical procedures

1. Coronary artery bypass grafting (on or off pump)

2. Bioprosthetic aortic valve replacement

3. Mitral valve repair

4. Ascending aorta procedures

5. Tricuspid valve repair

6. Pulmonic valve procedures.

3. An indication for oral anticoagulation

1. Pre-existing AF

2. New post-operative atrial fibrillation

3. Arterial embolism

4. Venous thromboembolism.

Exclusion Criteria:

1. Cardiac surgical procedure

1. Redo-sternotomy

2. Bioprosthetic mitral valve replacement

3. Mechanical valve replacement

4. Transcatheter valve procedure

5. Aortic arch procedures

6. Pericardectomy

7. Post-operative extracorporeal membrane oxygenation

8. Heart transplant

9. Ventricular assist devices

10. Congenital heart procedures

2. Stroke within 4 weeks prior to surgery or postoperatively prior to initiation of study drug

3. Recent history of heparin-induced thrombocytopenia (less than 3 months)

4. High risk for bleeding (e.g. major bleed [intracranial hemorrhage, gastrointestinal bleed] within past 3 months, unexplained drop in hemoglobin pre-operatively)

5. Postoperative bleeding requiring return to operating room for exploration prior to randomization

6. Perioperative severe renal failure, defined as any eGFR <30 mL/min/1.73m2 or requirement of dialysis

7. Perioperative liver failure with alanine aminotransferase > 3x upper limit of normal

8. Pregnant or lactating women

9. Patient unable to consent

10. Contraindication to any study drug (including use of concomitant strong P-glycoprotein or cytochrome P450 enzyme inducers/inhibitors).