DOAC Versus VKA After Cardiac Surgery (DOAC/VKA)

March 9, 2023 updated by: Pierre Voisine, Laval University

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
      • Quebec, Canada, G1V4G5
        • Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group VKA

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
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.
Other Names:
  • Coumadin
Active Comparator: Group DOAC

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
Drug: 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.
Other Names:
  • Pradaxa
Drug: 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.
Other Names:
  • Xarelto
Drug: 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.
Other Names:
  • Eliquis
Drug: 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.
Other Names:
  • Lixiana

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemorrhagic events with anticoagulant treatment
Time Frame: Evaluation at month 3 after hospital discharge for all the postoperative period
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
Ischemic events with anticoagulant treatment
Time Frame: Evaluation at month 3 after hospital discharge for all the postoperative period
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
Death with anticoagulant treatment
Time Frame: Evaluation at month 3 after hospital discharge for all the postoperative period
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
Quality of life with anticoagulant treatment
Time Frame: Evaluation at month 3 after hospital discharge for the last month
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
Statisfaction of the anticoagulant treatment
Time Frame: Evaluation at month 3 after hospital discharge for the last month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 9, 2022

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Actual)

March 9, 2023

Study Registration Dates

First Submitted

June 10, 2019

First Submitted That Met QC Criteria

June 26, 2019

First Posted (Actual)

June 28, 2019

Study Record Updates

Last Update Posted (Actual)

March 13, 2023

Last Update Submitted That Met QC Criteria

March 9, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21755

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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