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出境医 / 临床实验 / DOAC Versus VKA After Cardiac Surgery (DOAC/VKA)
DOAC Versus VKA After Cardiac Surgery (DOAC/VKA)
Study Description
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.
Study Design
| 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 : | September 1, 2022 |
| Estimated Primary Completion Date : | January 30, 2024 |
| Estimated Study Completion Date : | June 1, 2024 |
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures :
- 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.
- 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.
- 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.
- 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).
- 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
Eligibility Criteria
| 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
Contacts and Locations
Contacts
| Contact: Hugo Tremblay, RN | 418-656-8711 ext 3797 | hugo.tremblay@criucpq.ulaval.ca | |
| Contact: Pierre Voisine, M.D. | 418-656-8711 | pierre.voisine@criucpq.ulaval.ca |
Locations
| Canada | |
| Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval | |
| Quebec, Canada, G1V4G5 | |
| Contact: Hugo Tremblay, Bachelor 418-656-8711 ext 3797 hugo.tremblay@criucpq.ulaval.ca | |
Sponsors and Collaborators
Laval University
Investigators
| Principal Investigator: | Pierre Voisine, M.D. | Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ) |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 10, 2019 | ||||||||
| First Posted Date ICMJE | June 28, 2019 | ||||||||
| Last Update Posted Date | February 18, 2021 | ||||||||
| Estimated Study Start Date ICMJE | September 1, 2022 | ||||||||
| Estimated Primary Completion Date | January 30, 2024 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
|
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | DOAC Versus VKA After Cardiac Surgery | ||||||||
| Official Title ICMJE | Oral Anticoagulation After Cardiac Surgery in the Era of Direct Oral Anticoagulants: is Large Use of Vitamin K Antagonists Still Justified? | ||||||||
| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Anticoagulant-induced Bleeding | ||||||||
| Intervention ICMJE |
|
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE |
206 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | June 1, 2024 | ||||||||
| Estimated Primary Completion Date | January 30, 2024 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Canada | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04002011 | ||||||||
| Other Study ID Numbers ICMJE | 21755 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | Pierre Voisine, Laval University | ||||||||
| Study Sponsor ICMJE | Laval University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | Laval University | ||||||||
| Verification Date | February 2021 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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