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Anticoagulant

Non-Vitamin K Oral Anticoagulant (NOAC) Group for Atrial Fibrillation

Phase 2

Waitlist Available

Research Sponsored by St. Paul's Hospital, Canada

Eligibility Criteria Checklist

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

Must have

Mitral valve repair

Pre-existing AF

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Study Summary

This trial will conduct a small study to compare different blood thinners in people at risk for blood clots after open-heart surgery. The aim is to gather data to design a larger study to test the

Who is the study for?

This trial is for adults over 18 who've had open-heart surgery like bypass grafting, valve repairs or replacements, and aorta procedures. They should need blood thinners due to pre-existing atrial fibrillation—a heart rhythm problem.Check my eligibility

What is being tested?

The study compares new blood thinners (NOACs) with the traditional one, Warfarin, in patients just after cardiac surgery. It's a small pilot study aimed at setting up for a larger future trial to assess safety and effectiveness.See study design

What are the potential side effects?

Possible side effects of NOACs and Warfarin include bleeding complications, allergic reactions, liver enzyme changes, and potential interactions with other drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had surgery to fix my mitral valve.

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I have a history of atrial fibrillation.

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I have had surgery on the large artery coming from my heart.

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I have had surgery to fix my tricuspid valve.

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I have undergone heart surgery.

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I have had heart bypass surgery.

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I need blood thinners for my condition.

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I have a bioprosthetic aortic valve replacement.

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I have had a procedure on my pulmonic valve.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Adherence rate to the anticoagulation protocol

Composite safety endpoint

Successful recruitment rate

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Non-Vitamin K Oral Anticoagulant (NOAC) GroupExperimental Treatment1 Intervention

Anticoagulation with a NOAC (Apixaban, Dabigatran, Edoxaban, Rivaroxaban)

Group II: Warfarin GroupActive Control1 Intervention

Anticoagulation with warfarin to target INR 2.5

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

St. Paul's Hospital, CanadaLead Sponsor

44 Previous Clinical Trials

12,620 Total Patients Enrolled

1 Trials studying Atrial Fibrillation

96 Patients Enrolled for Atrial Fibrillation

Frequently Asked Questions

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

Are there any available slots for patients to participate in this clinical trial?

"As per clinicaltrials.gov, the trial is presently not in search of participants. Initial posting was on October 12th, 2022 with the latest update noted on April 15th, 2024. Despite this specific study being inactive for recruitment, there are currently 524 other trials actively enrolling patients."

Answered by AI

What is the upper limit on the number of individuals involved in this clinical study?

"As of now, recruitment for this trial has concluded. It was initially listed on October 12th, 2022, with the latest update made on April 15th, 2024. For those seeking other research opportunities in atrial fibrillation and Non-Vitamin K Oral Anticoagulant (NOAC) Group studies, there are currently 485 and 39 active trials respectively looking to enroll participants."

Answered by AI

For what medical purposes are Non-Vitamin K Oral Anticoagulants (NOACs) commonly prescribed?

"Typically, Vitamin K deficiency is managed with medications from the Non-Vitamin K Oral Anticoagulant (NOAC) class. This group of drugs is beneficial not only for addressing vitamin K-related issues but also proves effective in managing ailments such as stroke, systemic embolism, and ulcerative colitis."

Answered by AI

Has the FDA authorized the use of Non-Vitamin K Oral Anticoagulant (NOAC) Group?

"Based on our evaluation at Power, the safety rating for the Non-Vitamin K Oral Anticoagulant (NOAC) Group falls at a level 2. This assessment is made in consideration of it being a Phase 2 trial where existing data supports its safety profile without substantial evidence backing its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Safety of Non-vitamin K Oral Anticoagulants Compared to Warfarin Early After Cardiac Surgery

Jian Ye, MD 2022. "The Safety of Non-vitamin K Oral Anticoagulants Compared to Warfarin Early After Cardiac Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05006287.

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