DOAC Versus VKA After Cardiac Surgery (DOAC/VKA)

Laval University

Status and phase: Withdrawn; Phase 2

Conditions: Anticoagulant-induced Bleeding

Treatments: Drug: Edoxaban; Drug: Warfarin; Drug: Apixaban; Drug: Rivaroxaban; Drug: Dabigatran

Study type: Interventional

Funder types: Other

Identifiers

NCT04002011

21755

Details and patient eligibility

About

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.

Full description

This study will be composed by 2 groups of 103 participants, patients undergoing cardiac surgery and needing oral anticoagulation in the early postoperative period.

The control group will receive vitamin K antagonist and the study group will receive direct oral anticoagulant. The investigators will call back each participants at 3 months to report the ischemic and bleeding complications during this period and evaluated the quality of life of the oral anticoagulation.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Group VKA

Active Comparator group

Description:

103 patients. First intake at postoperative day 1 or later when anticoagulation is secondary indicated. Dosage adapted to INR = \[2.0-3.0\], parenteral (subcoutaneous low-weight molecular or intravenous unfractionated heparin) until INR \> or = 2.0. Daily INR during hospital stay, then management by familial doctor. Duration: 3 months

Treatment:

Drug: Warfarin

Group DOAC

Active Comparator group

Description:

103 patients - One drug among the 4 DOAC according the morbidity of each patient (preoperative DOAC, oral nutrition recovery). First intake at hospital discharge - parenteral (subcoutaneous low-weight molecular or intravenous unfractionated heparin) during hospital stay. Regular daily dosages according the drug, its indication (atrial fibrillation/flutter or biological mitral replacement/repair or biological tricuspid replacement versus venous thromboembolism) and the morbidity of each patient (age, weight, creatinine ou its clearance). Validation by one referent pharmacist. No biological monitoring. Duration: 3 months

Treatment:

Drug: Rivaroxaban

Drug: Dabigatran

Drug: Apixaban

Drug: Edoxaban