Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2022-03-09
2023-03-09
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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.
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
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Laval University
OTHER
Responsible Party
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Pierre Voisine
Principal Investigator
Principal Investigators
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Pierre Voisine, M.D.
Role: PRINCIPAL_INVESTIGATOR
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
Other Identifiers
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21755
Identifier Type: -
Identifier Source: org_study_id
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