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DOAC Versus VKA After Cardiac Surgery (DOAC/VKA)

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ClinicalTrials.gov Identifier: NCT04002011
Recruitment Status : Not yet recruiting
First Posted : June 28, 2019
Last Update Posted : September 5, 2019
Sponsor:
Information provided by (Responsible Party):
Pierre Voisine, Laval University

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.

Condition or disease Intervention/treatment Phase
Anticoagulant-induced Bleeding Drug: Warfarin Drug: Dabigatran Drug: Rivaroxaban Drug: Apixaban Drug: Edoxaban Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Oral Anticoagulation After Cardiac Surgery in the Era of Direct Oral Anticoagulants: is Large Use of Vitamin K Antagonists Still Justified?
Estimated Study Start Date : October 30, 2019
Estimated Primary Completion Date : January 30, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: 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 Name: 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 Name: Lixiana




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04002011


Contacts
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Contact: Alexandre Sebestyen, Fellowship +1 (581) 982-3746 sebestyen.alexandre@gmail.com
Contact: Pierre Voisine, M.D. pierre.voisine@criucpq.ulaval.ca

Locations
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Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval
Quebec, Canada, G1V4G5
Sponsors and Collaborators
Laval University
Investigators
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Principal Investigator: Pierre Voisine, M.D. Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

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Responsible Party: Pierre Voisine, Principal Investigator, Laval University
ClinicalTrials.gov Identifier: NCT04002011     History of Changes
Other Study ID Numbers: 21755
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: September 2019

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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
Keywords provided by Pierre Voisine, Laval University:
direct oral anticoagulant
vitamin K antagonist
cardiac surgery
perioperative care
Additional relevant MeSH terms:
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Vitamin K
Warfarin
Vitamins
Hemorrhage
Pathologic Processes
Rivaroxaban
Dabigatran
Apixaban
Edoxaban
Anticoagulants
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifibrinolytic Agents
Fibrin Modulating Agents
Hemostatics
Coagulants