← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days after randomization

Awards & highlights

PACES 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.Check my eligibility

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.See study design

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.

PACES Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 or older and had bypass surgery for heart disease.

PACES Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days after randomization

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

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

Primary outcome measures

Any BARC type 3 or 5

Composite of death, ischemic stroke, TIA, MI, systemic arterial thromboembolism or venous thromboembolism (DVT and/or PE)

Secondary outcome measures

Net clinical benefit (NCB)

Number of cardiac arrhythmias

Number of cardiovascular mortalities

+8 more

PACES Trial Design

2Treatment groups

Active Control

Group I: Antiplatelet TherapyActive Control1 Intervention

Antiplatelet-only strategy

Group II: Oral AnticoagulantActive Control1 Intervention

OAC-based strategy

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

860 Previous Clinical Trials

521,276 Total Patients Enrolled

2 Trials studying Atrial Fibrillation

1,037 Patients Enrolled for Atrial Fibrillation

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,836 Previous Clinical Trials

47,847,657 Total Patients Enrolled

45 Trials studying Atrial Fibrillation

536,393 Patients Enrolled for Atrial Fibrillation

Vanderbilt University Medical CenterOTHER

857 Previous Clinical Trials

668,997 Total Patients Enrolled

10 Trials studying Atrial Fibrillation

2,002 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

Frequently Asked Questions

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

What potential risks can patients face when undergoing Antiplatelet Therapy?

"There is now an official endorsement for Antiplatelet Therapy, thus garnering a score of 3."

Answered by AI

Are there any Canadian hospitals that are currently conducting this clinical trial?

"Presently, this research endeavour is taking place at 57 medical sites across the US and Canada. Locations range from Boston to Baltimore to Toronto and many other cities in between; thus, prospective participants should select the closest centre for their convenience."

Answered by AI

Are there still openings for participants in this research initiative?

"According to clinicaltrials.gov, this research endeavour is open for recruitment, with the initial posting on December 13th 2019 and latest update occurring November 3rd 2022."

Answered by AI

How many participants are enrolling in this research study?

"To meet the demands of this study, 3200 participants fitting the inclusion criteria are necessary. These patients can access this clinical trial from Massachusetts General Hospital in Boston and Johns Hopkins in Baltimore respectively."

Answered by AI