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Direct Oral Anticoagulant

Group VKA for Bleeding (DOAC/VKA Trial)

Phase 2

Waitlist Available

Led By Pierre Voisine, M.D.

Research Sponsored by Laval University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up evaluation at month 3 after hospital discharge for the last month

Awards & highlights

DOAC/VKA Trial Summary

This trial looks at whether direct oral anticoagulants are safe and effective to use in the postoperative period for people who have had cardiac surgery.

DOAC/VKA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ evaluation at month 3 after hospital discharge for the last month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~evaluation at month 3 after hospital discharge for the last month

This trial's timeline: 3 weeks for screening, Varies for treatment, and evaluation at month 3 after hospital discharge for the last month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Death with anticoagulant treatment

Hemorrhagic events with anticoagulant treatment

Ischemic events with anticoagulant treatment

+2 more

DOAC/VKA Trial Design

2Treatment groups

Active Control

Group I: Group VKAActive Control1 Intervention

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

Group II: Group DOACActive Control4 Interventions

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

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Who is running the clinical trial?

Laval UniversityLead Sponsor

417 Previous Clinical Trials

172,272 Total Patients Enrolled

Pierre Voisine, M.D.Principal InvestigatorInstitut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what medical scenarios is Group VKA typically administered?

"Group VKA has been found to be a beneficial remedy for cerebrovascular accident as well as systemic embolism, myocardial infarction, and atrial fibrillation."

Answered by AI

Has Group VKA received federal sanction from the FDA?

"Group VKA's safety, which is supported by preliminary studies, was rated 2 based on our internal evaluation. This score reflects the lack of any data indicating efficacy."

Answered by AI

How many test subjects are permitted to take part in the current trial?

"Currently, the recruitment process for this trial has been suspended. It was first published on December 1st 2022 and had its last update in August 18th 2022. For those looking to participate in other clinical trials, there are 6 studies recruiting patients with anticoagulant-induced bleeding and 113 trials actively accepting participants for Group VKA therapy."

Answered by AI

Is this experiment actively seeking volunteers?

"This clinical trial is not enrolling participants at the moment. Its initial listing was on December 1st 2022 and its latest update occurred on August 18th of the same year. However, if you're seeking alternatives, 6 trials related to anticoagulant-induced bleeding are recruiting as well as 113 studies concerning Group VKA that need volunteers."

Answered by AI

Have any other experiments been conducted using Group VKA?

"Presently, there are 113 ongoing clinical trials exploring the efficacy of Group VKA with 42 in Phase 3. Montreal, Quebec is leading these studies but 2005 other sites around the globe have also contributed to this research effort."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

DOAC Versus VKA After Cardiac Surgery

Pierre Voisine 2022. "DOAC Versus VKA After Cardiac Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04002011.