DOAC Versus VKA After Cardiac Surgery

NCT04002011 | Withdrawn Phase 2

• 1 other identifier: 21755
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anticoagulant-induced Bleeding

Keywords

direct oral anticoagulant; vitamin K antagonist; cardiac surgery; perioperative care

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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).

  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

  Evaluation at month 3 after hospital discharge for the last month

Study Arms (2)

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

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

Drug: Dabigatran; Drug: Rivaroxaban; Drug: Apixaban; Drug: Edoxaban

Interventions

Warfarin DRUG

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.

Also known as: Coumadin

Group VKA

Dabigatran DRUG

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.

Also known as: Pradaxa

Group DOAC

Rivaroxaban DRUG

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.

Also known as: Xarelto

Group DOAC

Apixaban DRUG

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.

Also known as: Eliquis

Group DOAC

Edoxaban DRUG

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.

Also known as: Lixiana

Group DOAC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead

MeSH Terms

Interventions

Warfarin; Dabigatran; Rivaroxaban; apixaban; edoxaban

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyridines; Benzimidazoles; Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines

Study Officials

• Pierre Voisine, M.D.

  Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: June 28, 2019
• Study Start: March 9, 2022
• Primary Completion: January 1, 2023
• Study Completion: March 9, 2023
• Last Updated: March 13, 2023

Record last verified: 2023-03