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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
Approved for 20 Other Conditions
No Placebo-Only Group
All Individual Drugs Already Approved

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adherence rate to the anticoagulation protocol
Composite safety endpoint
Successful recruitment rate

Awards & Highlights

Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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

Find a Location

Who is running the clinical trial?

St. Paul's Hospital, CanadaLead Sponsor
46 Previous Clinical Trials
13,020 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
96 Patients Enrolled for Atrial Fibrillation
~32 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
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