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DOAC Versus VKA After Cardiac Surgery

NCT04002011 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-03-13

No results posted yet for this study

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

Interventions

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.

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.

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.

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.

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.

Sponsors & Collaborators

  • Laval University

    lead OTHER

Principal Investigators

  • Pierre Voisine, M.D. · Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-09
Primary Completion
2023-01-01
Completion
2023-03-09

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04002011 on ClinicalTrials.gov