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

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: St. Paul's Hospital, Canada

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

A small pilot study comparing different blood thinners (non-vitamin K oral anticoagulants \[NOACs\] and warfarin) will be conducted in people at risk for blood clots after open-heart surgery. This study will help us design a much bigger study to test the effectiveness and safety of different blood thinners in people after open-heart surgery. The study will test the following hypotheses: (1) Our standardized use of different blood thinners is feasible in patients early after cardiac surgery. (2) NOACs are safe to use early after cardiac surgery.

Research Team

Eligibility Criteria

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.

Inclusion Criteria

I have had surgery to fix my mitral valve.

I have a history of atrial fibrillation.

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

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Treatment Details

Interventions

Non-vitamin K oral anticoagulants (NOACs) (Anticoagulant)
Warfarin (Anticoagulant)

Trial OverviewThe 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.

Participant Groups

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