Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG (PACES)

May 19, 2023 updated by: Annetine Gelijns, Icahn School of Medicine at Mount Sinai

The primary objective of this study is to evaluate the effectiveness (prevention of thromboembolic events) and safety (major bleeding) of adding oral anticoagulation (OAC) to background antiplatelet therapy in patients who develop new-onset post-operative atrial fibrillation (POAF) after isolated coronary artery bypass graft (CABG) surgery.

All patients with a qualifying POAF event, who decline randomization, will be offered the option of enrollment in a parallel registry that captures their baseline risk profile and their treatment strategy in terms of anticoagulants or antiplatelets received. These patients will also be asked to fill out a brief decliner survey.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, multicenter, open-label, randomized trial comparing OAC with no OAC (1:1 ratio) in patients who develop new-onset POAF after CABG. The primary effectiveness endpoint is the composite of death, ischemic stroke, transient ischemic attack (TIA), myocardial infarction (MI), systemic arterial thromboembolism or venous thromboembolism (VTE) at 90 days after randomization. The primary safety endpoint is BARC (Bleeding Academic Research Consortium) grade 3 or 5 bleeding at 90 days after randomization. The overall intent is to evaluate the trade-off in prevention of thromboembolic events versus an increase in bleeding.

Patients will be randomly assigned to the following treatment strategies:

  • OAC-based strategy (experimental arm): OAC with vitamin K antagonist (VKA) with international normalized ratio (INR) target 2-3 or any approved direct oral anticoagulant (apixaban, rivaroxaban, edoxaban or dabigatran) in addition to background antiplatelet therapy with aspirin 75-325mg once-daily or a P2Y12-inhibitor (clopidogrel or ticagrelor)
  • Antiplatelet-only strategy (control arm): single antiplatelet therapy with aspirin 75-325mg once-daily or a P2Y12-inhibitor (clopidogrel or ticagrelor)

The protocol-specified duration of anticoagulation is 90 days. Patients, who are randomized to the control arm and develop recurrent AF after 30 days, may be crossed-over to an OAC. Accrual is expected to take 60 months. Study follow-up visits will be performed at 90 days and phone follow-up at days 30, 60, and 180 days.

Data for patients enrolled in the registry will be ascertained from the local clinical site via a review of medical records. The baseline risk profile of registry patients (i.e., patients eligible but unwilling to be randomized) will be analyzed and compared to that of patients randomized in the trial. The usage of anticoagulant and antiplatelet therapies in the registry population overall and baseline CHA2DS2-VASC ischemic stroke risk score will also be determined.

Up to 500 patients will also be offered the option to participate in a digital health substudy which includes a wearable heart rhythm monitor device for 30 days post discharge.

Study Type

Interventional

Enrollment (Anticipated)

3200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G2B7
        • Recruiting
        • University of Alberta Hospital
        • Contact:
        • Principal Investigator:
          • Steven Meyer, MD
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • Recruiting
        • London Health Sciences Centre
        • Contact:
        • Principal Investigator:
          • Michael Chu
      • Ottawa, Ontario, Canada, K1Y 4W7
        • Not yet recruiting
        • University of Ottawa Heart Institute
        • Contact:
        • Principal Investigator:
          • Marc Ruel
      • Toronto, Ontario, Canada, M4N 3M5
      • Toronto, Ontario, Canada, M5B 1W8
        • Not yet recruiting
        • Toronto General Hospital
        • Contact:
        • Principal Investigator:
          • Terrance Yau
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
      • Montreal, Quebec, Canada, H2W 1T8
      • Montreal, Quebec, Canada, H4J 1C5
        • Not yet recruiting
        • Hôpital du Sacré-Coeur de Montreal
        • Contact:
        • Principal Investigator:
          • Hugues Jeanmart
  • Germany
      • Bad Neustadt An Der Saale, Germany
        • Not yet recruiting
        • Clinic Bad Neustadt - Medical Center for Heart and Vascular Diseases
        • Contact:
        • Principal Investigator:
          • Anno Diegeler
      • Bad Oeynhausen, Germany
        • Not yet recruiting
        • HDZ-NRW Bad Oeynhausen
        • Contact:
        • Principal Investigator:
          • Kavous Hakim-Meibodi, MD
      • Berlin, Germany
        • Recruiting
        • German Heart Center Berlin
        • Contact:
        • Principal Investigator:
          • Volkmar Falk, MD
      • Berlin, Germany
        • Not yet recruiting
        • Charité Berlin - Benjamin Franklin Campus
        • Contact:
        • Principal Investigator:
          • Ulf Landmesser, MD
      • Berlin, Germany
        • Not yet recruiting
        • Charité Berlin - Rudolf Virchow Campus
        • Contact:
        • Principal Investigator:
          • Burkert Pieske, MD
      • Bonn, Germany
        • Recruiting
        • University Hospital Bonn
        • Principal Investigator:
          • Farhad Bakhtiary
        • Contact:
      • Braunschweig, Germany
      • Frankfurt, Germany
        • Not yet recruiting
        • University Medical Center Frankfurt
        • Contact:
        • Principal Investigator:
          • Thomas Walther, MD
      • Freiburg, Germany
      • Heidelberg, Germany
        • Not yet recruiting
        • University Medical Center Heidelberg
        • Contact:
          • Christiane Miesel-Groeschel
        • Principal Investigator:
          • Gábor Szabó, MD
      • Kiel, Germany
        • Not yet recruiting
        • University Medical Center Schleswig-Holstein Kiel
        • Contact:
        • Principal Investigator:
          • Assad Haneya, MD
      • Lübeck, Germany
        • Not yet recruiting
        • University Medical Center Schleswig-Holstein Lübeck
        • Contact:
        • Principal Investigator:
          • Stefan Klotz, MD
      • Munich, Germany
        • Not yet recruiting
        • German Heart Center Munich
        • Contact:
        • Principal Investigator:
          • Markus Krane, MD
      • Munich, Germany
        • Not yet recruiting
        • Medical Center of the Ludwig-Maximilians-University Munich
        • Contact:
        • Principal Investigator:
          • Christian Hagl, MD
    • Brandenburg
      • Berlin, Brandenburg, Germany, 11353
        • Not yet recruiting
        • University Heart Center Hamburg
        • Contact:
        • Principal Investigator:
          • Lennard Conradi, MD
      • Berlin, Brandenburg, Germany, 13347
    • Lower Saxony
      • Göttingen, Lower Saxony, Germany
    • Thuringia
      • Jena, Thuringia, Germany
  • United Kingdom
      • Bristol, United Kingdom, BS1 3NU
        • Recruiting
        • University Hospitals Bristol NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Hunaid Vohra
      • Cottingham, United Kingdom, HU16 5JQ
        • Recruiting
        • Hull University Teaching Hospitals NHS Trust
        • Contact:
      • Middlesbrough, United Kingdom
        • Recruiting
        • South Tees Hospitals NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Ralph White
      • Nottingham, United Kingdom
        • Recruiting
        • Nottingham University Hospitals NHS Trust
        • Contact:
        • Principal Investigator:
          • Anas Boulemden
      • Oxford, United Kingdom, OX3 9DU
      • Sheffield, United Kingdom
        • Recruiting
        • Sheffield Teaching Hospitals NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Steven Hunter
      • Worthing, United Kingdom, BN11 2DH
        • Recruiting
        • University Hospitals Sussex NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Istiaq M Ahmed
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • CHI St. Vincent, Arkansas
        • Contact:
        • Principal Investigator:
          • Thurston Bauer
    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
        • Contact:
        • Principal Investigator:
          • Joanna Chikwe, MD
      • Los Angeles, California, United States, 90033
        • Recruiting
        • University of Southern California
        • Principal Investigator:
          • Vaughn Starnes, MD
        • Contact:
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford University
        • Contact:
        • Principal Investigator:
          • Jack Boyd
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Active, not recruiting
        • Medical Center of Aurora
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Active, not recruiting
        • Western Connecticut Hospital Systems
      • New Haven, Connecticut, United States, 06520-8039
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • Medstar Washington Hospital Center
        • Principal Investigator:
          • Christian Shults, MD
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University
        • Contact:
        • Principal Investigator:
          • Michael Halkos
      • Atlanta, Georgia, United States, 30309
        • Recruiting
        • Piedmont Healthcare Inc.
        • Contact:
        • Principal Investigator:
          • Vinod Thourani, MD
    • Indiana
      • Fort Wayne, Indiana, United States, 46825
        • Recruiting
        • Lutheran Medical Center
        • Contact:
        • Principal Investigator:
          • Vincent Scavo
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University
        • Contact:
        • Principal Investigator:
          • Joel Corvera, MD
      • Indianapolis, Indiana, United States, 46260
        • Recruiting
        • Ascension St. Vincent
        • Contact:
        • Principal Investigator:
          • David Heimansohn
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
    • Maine
      • Portland, Maine, United States, 04102
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland
        • Contact:
        • Principal Investigator:
          • Mehrdad Ghoreishi, MD
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins
        • Contact:
        • Sub-Investigator:
          • James Gammie, MD
        • Principal Investigator:
          • Thomas Matthew, MD
      • Bethesda, Maryland, United States, 20814
        • Recruiting
        • Suburban Hospital
        • Contact:
        • Principal Investigator:
          • Thomas Matthew
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
        • Contact:
        • Principal Investigator:
          • Sary Aranki
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
        • Principal Investigator:
          • David D'Alessandro
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston Medical Center
        • Contact:
        • Principal Investigator:
          • Darae Ko, MD
      • Springfield, Massachusetts, United States, 01199
        • Active, not recruiting
        • Baystate Health
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Contact:
        • Principal Investigator:
          • Jonathan Haft, MD
        • Sub-Investigator:
          • Gorav Ailawadi, MD
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Not yet recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Juan Crestanello
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • Mid America Health Institute
        • Contact:
        • Principal Investigator:
          • Keith Allen
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Principal Investigator:
          • Tsuyoshi Kaneko, MD
        • Contact:
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766
    • New Jersey
      • Neptune, New Jersey, United States, 07753
    • New York
      • Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center
        • Contact:
        • Principal Investigator:
          • Daniel Goldstein, MD
      • Great Neck, New York, United States, 11023
        • Recruiting
        • Northwell Health System
        • Principal Investigator:
          • Nirav Patel
        • Contact:
        • Sub-Investigator:
          • Alexander Iribarne
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center
        • Contact:
        • Principal Investigator:
          • Michael Argenziano
      • New York, New York, United States, 10029
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University
        • Contact:
        • Principal Investigator:
          • Brittany Zwischenberger, MD
      • Greenville, North Carolina, United States, 27858
        • Recruiting
        • East Carolina University
        • Contact:
        • Principal Investigator:
          • Shahab A. Akhter
      • Raleigh, North Carolina, United States, 27610
        • Not yet recruiting
        • WakeMed
        • Contact:
        • Principal Investigator:
          • Judson Williams
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation
        • Contact:
        • Principal Investigator:
          • A Marc Gillinov
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Medical Center
        • Contact:
        • Principal Investigator:
          • Bryan Whitson
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74103
        • Recruiting
        • Ascension St. John
        • Contact:
        • Principal Investigator:
          • James Neel, MD
    • Pennsylvania
      • Hermitage, Pennsylvania, United States, 16148
        • Not yet recruiting
        • University of Pittsburgh Medical Center
        • Contact:
        • Principal Investigator:
          • Robert Kormos
      • Philadelphia, Pennsylvania, United States, 19104
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny Health Network
        • Contact:
        • Principal Investigator:
          • M. Scott Halbreiner, MD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
        • Contact:
        • Principal Investigator:
          • Todd Rosengart
      • Plano, Texas, United States, 75093
        • Recruiting
        • Baylor Research Institute
        • Contact:
        • Principal Investigator:
          • Michael DiMaio, MD
    • Utah
      • Murray, Utah, United States, 84107
        • Recruiting
        • Intermountain CV Research
        • Contact:
        • Principal Investigator:
          • Stephen McKellar, MD
      • Salt Lake City, Utah, United States, 84112
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Recruiting
        • University of Vermont
        • Contact:
        • Principal Investigator:
          • Marek Polomsky, MD
    • Virginia
      • Charlottesville, Virginia, United States, 22908
      • Falls Church, Virginia, United States, 22042
        • Active, not recruiting
        • INOVA Health
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • West Virginia University
        • Contact:
        • Principal Investigator:
          • Vinay Badhwar
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin
        • Contact:
        • Principal Investigator:
          • Satoru Osaki, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients of age ≥18 years who undergo isolated CABG for coronary artery disease
  • POAF that persists for >60 minutes or is recurrent (more than one episode) within 7 days after the index CABG surgery

Exclusion Criteria:

  • Clinical history of either permanent, persistent or paroxysmal atrial fibrillation
  • Any pre-existing clinical indication for long-term OAC
  • Any absolute contraindication to OAC

  • Planned use of post-operative dual antiplatelet therapy (DAPT)

    a. This includes, but is not limited to, patients with recent PCI with drug-eluting or bare-metal stent.

  • Cardiogenic shock

  • Major perioperative complication* occurring between CABG and randomization

    a. including, but not limited to, stroke, TIA, MI, major bleeding (BARC type 4 bleeding), severe sepsis, renal failure requiring dialysis, or need for reoperation due to bleeding (e.g. pericardial tamponade).

  • Concomitant left atrial appendage closure during CABG
  • Concomitant valve surgery during CABG or prior valve surgery (including aortic, mitral, tricuspid or pulmonary)
  • Concomitant mitral valve annuloplasty during CABG
  • Concomitant carotid artery endarterectomy during CABG
  • Concomitant aortic root replacement during CABG
  • Concomitant surgery for AF during CABG
  • Liver cirrhosis or Child-Pugh Class C chronic liver disease
  • Pharmacologic therapy with an investigational drug or device within 30-days prior to randomization or plan to enroll patient in an investigational drug or device trial during participation in this trial
  • Pregnancy at the time of randomization
  • Unable or unwilling to provide inform consent
  • Unable or unwilling to comply with the study treatment and follow-up
  • Existence of underlying disease that limits life expectancy to less than one year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Antiplatelet Therapy
Antiplatelet-only strategy
Drug: Antiplatelet-only strategy
Aspirin 75-325 mg once-daily or a P2Y12-inhibitor (clopidogrel or ticagrelor)
Active Comparator: Oral Anticoagulant
OAC-based strategy
Drug: Oral Anticoagulant plus background antiplatelet therapy
OAC with vitamin K antagonist (VKA) with international normalized ratio (INR) target 2-3 or any approved direct oral anticoagulant OR apixaban, rivaroxaban, edoxaban or dabigatran) in addition to background antiplatelet therapy with aspirin 75-325mg once-daily or a P2Y12-inhibitor (clopidogrel or ticagrelor)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Any BARC type 3 or 5
Time Frame: 90 days after randomization

The Bleeding Academic Research Consortium (BARC) - any type 3 or 5 bleeding thrombosis and/or pulmonary.

Type 3: a. Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL (provided hemoglobin drop is related to bleed); transfusion with overt bleeding

b. Overt bleeding plus hemoglobin drop < 5 g/dL (provided hemoglobin drop is related to bleed); cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring IV vasoactive agents

c. Intracranial hemorrhage confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision.

type 5: a. Probable fatal bleeding

b. Definite fatal bleeding (overt or autopsy or imaging confirmation)
90 days after randomization
Composite of death, ischemic stroke, TIA, MI, systemic arterial thromboembolism or venous thromboembolism (DVT and/or PE)
Time Frame: up to 180 days after randomization
Composite score of death, ischemic stroke, transient ischemic attack (TIA), myocardial infarction (MI), systemic arterial thromboembolism or venous thromboembolism (deep venous thrombosis and/or pulmonary embolism). Composite score calculated by number of events.
up to 180 days after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Net clinical benefit (NCB)
Time Frame: 90 days after randomization
Defined as the integration of the trial's primary effectiveness and safety endpoint to capture overall risk and benefit of anticoagulation. NCB will be assessed as a two-dimensional outcome with the observed NCB plotted versus effectiveness and safety, and a curve drawn. the confidence intervals will be compared to this curve.
90 days after randomization
Number of participants with TIA event
Time Frame: 180 days after randomization
180 days after randomization
Number of participants with MI event
Time Frame: 180 days after randomization
180 days after randomization
Number of participants with systematic arterial thromboembolism event
Time Frame: 180 days after randomization
180 days after randomization
Number of participants with venous thromboembolism event
Time Frame: 180 days after randomization
180 days after randomization
Number of cardiovascular mortalities
Time Frame: up to 180 days after randomization
up to 180 days after randomization
Number of non-cardiovascular mortalities
Time Frame: up to 180 days after randomization
up to 180 days after randomization
Number of participants with Ischemic Stroke event
Time Frame: 180 days after randomization
180 days after randomization
The incidence of BARC 2 bleeding at 90 after randomization
Time Frame: 90 days after randomization
BARC Type 2: Any clinically overt sign of hemorrhage that "is actionable" and requires diagnostic studies, hospitalization, or treatment by a health care professional
90 days after randomization
The incidence of BARC 2 bleeding at 180 days after randomization
Time Frame: 180 days after randomization
BARC Type 2: Any clinically overt sign of hemorrhage that "is actionable" and requires diagnostic studies, hospitalization, or treatment by a health care professional
180 days after randomization
Number of cardiac arrhythmias
Time Frame: 180 days after randomization
Number of cardiac arrhythmias including recurrent symptomatic or asymptomatic AF requiring medical attention
180 days after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
Vanderbilt University Medical Center

Investigators

  • Principal Investigator: Annetine C Gelijns, PhD, Icahn School of Medicine at Mount Sinai
  • Study Director: Marc Gillinov, MD, The Cleveland Clinic
  • Study Director: John Alexander, MD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2019

Primary Completion (Anticipated)

June 30, 2025

Study Completion (Anticipated)

June 30, 2025

Study Registration Dates

First Submitted

August 2, 2019

First Submitted That Met QC Criteria

August 2, 2019

First Posted (Actual)

August 5, 2019

Study Record Updates

Last Update Posted (Actual)

May 23, 2023

Last Update Submitted That Met QC Criteria

May 19, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 08-1078
  • 2U01HL088942-12 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

IPD Sharing Time Frame

OtherDe-identified study data sets must be submitted to the designated NHLBI Program Official no later than 3 years after the end of the clinical activity (final patient follow-up, etc.) or 2 years after the main paper of the trial has been published, whichever comes first. Data are prepared by the study coordinating center and sent to the designated PO for review prior to release.

IPD Sharing Access Criteria

Anyone who wishes to access the data.Any purpose.Data are available indefinitely at (Link to be included).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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