Anticoagulant-induced BleedingPhase 2DOAC/VKANCT04002011
DOAC Versus VKA After Cardiac Surgery
A Phase 2 study testing Warfarin, Dabigatran and Rivaroxaban in people with Anticoagulant-induced Bleeding, run by Laval University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anticoagulant-induced Bleeding
- What is being tested?
- Warfarin, Dabigatran and Rivaroxaban
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 9 Mar 2022to 9 Mar 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Anticoagulant-induced Bleeding
- Being tested
- Warfarin, Dabigatran, Rivaroxaban, Apixaban, Edoxaban
- Keywords
- direct oral anticoagulant, vitamin K antagonist, cardiac surgery, perioperative care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WarfarinDrug
Also called Coumadin
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.
DabigatranDrug
Also called Pradaxa
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.
RivaroxabanDrug
Also called Xarelto
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.
ApixabanDrug
Also called Eliquis
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.
EdoxabanDrug
Also called Lixiana
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.
| Study group | Role | What they receive |
|---|---|---|
| Group VKA | Active comparator | 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 Receives: Drug: Warfarin |
| Group DOAC | Active comparator | 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 Receives: Drug: Dabigatran; Drug: Rivaroxaban; Drug: Apixaban; Drug: Edoxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Evaluation at month 3 after hospital discharge for all the postoperative period
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.
Measured: Evaluation at month 3 after hospital discharge for all the postoperative period
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.
Measured: Evaluation at month 3 after hospital discharge for all the postoperative period
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).
Measured: Evaluation at month 3 after hospital discharge for the last month
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
Measured: Evaluation at month 3 after hospital discharge for the last month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start9 Mar 2022 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion9 Mar 2023
Why it stopped: Submission process abandoned. No patient enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anticoagulant-induced BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierre Voisine, Laval University
- Investigators
- Pierre Voisine, M.D., Principal investigator, Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04002011
- Sponsor's protocol ID
- 21755
- Acronym
- DOAC/VKA
- Status last verified
- Mar 2023
- First submitted
- 10 Jun 2019
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Anticoagulation After Cardiac Surgery in the Era of Direct Oral Anticoagulants: is Large Use of Vitamin K Antagonists Still Justified?
- ClinicalTrials.gov ID
- NCT04002011
- Acronym / sponsor ID
- DOAC/VKA / 21755
- Conditions
- Anticoagulant-induced Bleeding
- Keywords
- direct oral anticoagulant, vitamin K antagonist, cardiac surgery, perioperative care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Submission process abandoned. No patient enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 9 Mar 2022 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 9 Mar 2023 (actual)
- First posted
- 28 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group VKA | Active comparator | Drug: Warfarin103 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 |
| Group DOAC | Active comparator | Drug: Dabigatran, Drug: Rivaroxaban, Drug: Apixaban, Drug: Edoxaban103 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WarfarinAlso: CoumadinIt 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. | Drug | Group VKA |
| DabigatranAlso: PradaxaIt 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. | Drug | Group DOAC |
| RivaroxabanAlso: XareltoIt 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. | Drug | Group DOAC |
| ApixabanAlso: EliquisIt 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. | Drug | Group DOAC |
| EdoxabanAlso: LixianaIt 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. | Drug | Group DOAC |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Voisine, M.D. principal investigator
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Warfarin, Dabigatran and Rivaroxaban in people with Anticoagulant-induced Bleeding, run by Laval University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemorrhagic events with anticoagulant treatment (time frame: Evaluation at month 3 after hospital discharge for all the postoperative period). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.