DOAC Versus VKA After Cardiac Surgery

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Postoperative management of oral anticoagulation is a frequent preoccupation in cardiac surgery, concerning about half of patients. Vitamin K antagonists are often recommended but their management is not easy due to the high dose-response patient variability. Pharmacologically more stable, direct oral anticoagulants have similar efficiency in preventing thromboembolic complications while they decrease the risk of bleeding in certain patient populations. The objective of study is to assess the safety and efficacy of direct oral anticoagulants in the postoperative period of cardiac surgical procedures.

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

Details

• Lead Sponsor: Laval University
• Treatments: Anticoagulants; Apixaban; Dabigatran; Edoxaban; Rivaroxaban; Vitamin K; Warfarin

Criteria

Inclusion Criteria:

• Cardiac surgery, with or without cardiopulmonary bypass

• Indication of postoperative oral anticoagulation: preoperative (atrial fibrillation/flutter of idiopathic venous thromboembolism disease), intraoperative (bioprosthetic mitral valve replacement/mitral valve repair or bioprosthetic tricuspid valve repair), postoperative (de novo persistent more than 24 hours or recurrent atrial fibrillation/flutter, venous thromboembolism)

Exclusion Criteria:

• mechanical valvular prostheses or ventricular assist devices

• morbidly obesity (body mass index ≥ 40 kg/m²), prior biliopancreatic diversion or sleeve gastrectomy

• perioperative dysphagia needing naso-enteric tube or jejunostomy

• antiretroviral of antifungal oral therapy

• perioperative recent (less than 2 weeks) stroke

• perioperative severe renal failure (clearance of creatinine under 30 mL/min or dialysis)

• perioperative severe hepatic failure (elevated alanine aminotransferase more than 3 times the superior limit of normal range or cirrhosis)

• perioperative recent (less than 3 months) heparin-induced thrombocytopenia