DOAC Versus VKA After Cardiac Surgery

Anticoagulant-induced Bleeding Clinical Trial

— DOAC/VKA  

Official title:

Oral Anticoagulation After Cardiac Surgery in the Era of Direct Oral Anticoagulants: is Large Use of Vitamin K Antagonists Still Justified?

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04002011
• Other study ID #: 21755
• Status: Withdrawn
• Phase: Phase 2
• Start date: March 9, 2022
• Est. completion date: March 9, 2023

Study information

• Verified date: March 2023
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 9, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anticoagulant-induced Bleeding

Intervention

Drug:
• Warfarin
It will be started on postoperative day 1 or later when oral anticoagulation is secondary indicated. Daily dose will be adapted to obtain an international normalized ratio of [2.0-3.0]. Other anticoagulants will be not administrated.
• Dabigatran
It will be started when patients will be discharged from our center. Our pharmacist referent will validated the drug and its daily dose. Other anticoagulants will be not administrated.
• Rivaroxaban
It will be started when patients will be discharged from our center. Our pharmacist referent will validated the drug and its daily dose. Other anticoagulants will be not administrated.
• Apixaban
It will be started when patients will be discharged from our center. Our pharmacist referent will validated the drug and its daily dose. Other anticoagulants will be not administrated.
• Edoxaban
It will be started when patients will be discharged from our center. Our pharmacist referent will validated the drug and its daily dose. Other anticoagulants will be not administrated.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemorrhagic events with anticoagulant treatment	The investigators will use the regional computerized medical record of each participants to report all the hemorrhagic event during all the postoperative period, and define them according the "Bleeding Academic Research Consortium" (BARC) criteria. Hemorrhage-free survival will be studied.	Evaluation at month 3 after hospital discharge for all the postoperative period
Primary	Ischemic events with anticoagulant treatment	The investigators will use the regional computerized medical record of each patients to report all the ischemic event during all the postoperative period. Ischemia-free survival will be studied.	Evaluation at month 3 after hospital discharge for all the postoperative period
Primary	Death with anticoagulant treatment	The investigators will use the regional computerized medical record of each patients to report all the ischemic event during all the postoperative period. Global survival will be studied. Ischemic or hemorrhagic death will be precised.	Evaluation at month 3 after hospital discharge for all the postoperative period
Primary	Quality of life with anticoagulant treatment	The investigators will call back all the participants by phone and use the SF-12 questionnaire (score between 12 and 56) to evaluate the quality of life about several dimensions (global, physic, mental, pain, society).	Evaluation at month 3 after hospital discharge for the last month
Primary	Statisfaction of the anticoagulant treatment	The investigators will call back all the participants by phone and use the anti-clot treatment scale (ACTS) to evaluate the feelings of "burdens" (score between 12-60) and "benefits" (score between 3-15) of the anticoagulant treatment	Evaluation at month 3 after hospital discharge for the last month