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Anticoagulant

Anticoagulation + Antiplatelet Therapy for Post-Operative Atrial Fibrillation (PACES Trial)

Phase 3
Recruiting
Led By Annetine C Gelijns, PhD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients of age ≥18 years who undergo isolated CABG for coronary artery disease
Be older than 18 years old
Must not have
Existence of underlying disease that limits life expectancy to less than one year
Concomitant mitral valve annuloplasty during CABG
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days after randomization
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is looking at whether adding oral anticoagulation to background antiplatelet therapy is effective and safe in preventing thromboembolic events in patients who develop new-onset atrial fibrillation after isolated coronary artery bypass graft surgery.

Who is the study for?
This trial is for adults (≥18 years) who develop new, persistent or recurrent atrial fibrillation within 7 days after having a coronary artery bypass graft surgery. It's not for those with valve surgeries, major complications like stroke or bleeding post-surgery, pregnant women, people unable to consent or follow the study plan, those with less than one year life expectancy due to other diseases, prior history of atrial fibrillation, indications for long-term anticoagulation therapy outside of this condition, severe liver disease or recent participation in another drug/device trial.
What is being tested?
The study tests if adding oral anticoagulants to standard antiplatelet therapy is more effective and safe in preventing blood clots and reducing major bleeding risks in patients who have developed atrial fibrillation after coronary artery bypass surgery. Participants are either given just antiplatelets or a combination of antiplatelets and oral anticoagulants.
What are the potential side effects?
Potential side effects include increased risk of bleeding from the use of oral anticoagulants on top of antiplatelet drugs. The severity can range from minor bruising to serious bleeds that may require medical attention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 or older and had bypass surgery for heart disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My doctor expects I have less than a year to live due to my condition.
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I am having a procedure to repair my heart valve at the same time as my bypass surgery.
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I haven't used any experimental drugs or devices in the last 30 days.
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I have a history of atrial fibrillation.
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I cannot take blood thinners due to health reasons.
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I have had a severe heart condition called cardiogenic shock.
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I have had or will have heart valve surgery along with my bypass surgery.
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I need long-term blood thinners for a health condition.
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I am having my aortic root replaced at the same time as my bypass surgery.
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I have not had serious complications like stroke, severe bleeding, or kidney failure needing dialysis after my heart bypass surgery.
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I am willing and able to follow the study's treatment and check-up schedule.
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I will be taking two blood-thinning medications after surgery.
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I have severe liver disease.
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I am having a procedure to close the left atrial appendage during my heart bypass surgery.
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I am having a procedure to clear my carotid artery at the same time as my heart bypass surgery.
Select...
I am having surgery for atrial fibrillation during my bypass surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days after randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days after randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Any BARC type 3 or 5
Composite of death, ischemic stroke, TIA, MI, systemic arterial thromboembolism or venous thromboembolism (DVT and/or PE)
Secondary study objectives
Net clinical benefit (NCB)
Number of cardiac arrhythmias
The incidence of BARC 2 bleeding at 180 days after randomization
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Group I: Antiplatelet TherapyActive Control1 Intervention
Antiplatelet-only strategy
Group II: Oral AnticoagulantActive Control1 Intervention
OAC-based strategy

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
904 Previous Clinical Trials
538,605 Total Patients Enrolled
3 Trials studying Atrial Fibrillation
1,837 Patients Enrolled for Atrial Fibrillation
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,935 Previous Clinical Trials
47,789,131 Total Patients Enrolled
46 Trials studying Atrial Fibrillation
536,593 Patients Enrolled for Atrial Fibrillation
Vanderbilt University Medical CenterOTHER
902 Previous Clinical Trials
935,301 Total Patients Enrolled
12 Trials studying Atrial Fibrillation
2,402 Patients Enrolled for Atrial Fibrillation

Media Library

Oral Anticoagulant (Anticoagulant) Clinical Trial Eligibility Overview. Trial Name: NCT04045665 — Phase 3
Atrial Fibrillation Research Study Groups: Antiplatelet Therapy, Oral Anticoagulant
Atrial Fibrillation Clinical Trial 2023: Oral Anticoagulant Highlights & Side Effects. Trial Name: NCT04045665 — Phase 3
Oral Anticoagulant (Anticoagulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04045665 — Phase 3
~339 spots leftby Jun 2025
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