Clinical trial NCT04002011: DOAC Versus VKA After Cardiac Surgery
Official title: Oral Anticoagulation After Cardiac Surgery in the Era of Direct Oral Anticoagulants: is Large Use of Vitamin K Antagonists Still Justified?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Anticoagulant-induced Bleeding
Keywords: direct oral anticoagulant
vitamin K antagonist
cardiac surgery
perioperative care
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2019-06-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Hemorrhagic events with anticoagulant treatment
timeFrame: Evaluation at month 3 after hospital discharge for all the postoperative period
measure: Ischemic events with anticoagulant treatment
timeFrame: Evaluation at month 3 after hospital discharge for all the postoperative period
measure: Death with anticoagulant treatment
timeFrame: Evaluation at month 3 after hospital discharge for all the postoperative period
measure: Quality of life with anticoagulant treatment
timeFrame: Evaluation at month 3 after hospital discharge for the last month
measure: Statisfaction of the anticoagulant treatment
timeFrame: Evaluation at month 3 after hospital discharge for the last month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
name: Pierre Voisine, M.D.
role: PRINCIPAL_INVESTIGATOR
References: