AzTrials
AzTrials

Atrial FibrillationPhase 3PACESNCT04045665

Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG

A Phase 3 study testing Antiplatelet-only strategy and Oral Anticoagulant plus background antiplatelet therapy in people with Atrial Fibrillation and Stroke, run by Icahn School of Medicine at Mount Sinai at 106 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation, Stroke, Bleeding
What is being tested?
Antiplatelet-only strategy and Oral Anticoagulant plus background antiplatelet therapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,200 participants
Where
106 sitesin 5 countries
Study dates
13 Dec 2019to 31 Aug 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
  • This includes, but is not limited to, patients with recent PCI with drug-eluting or bare-metal stent.
  • Cardiogenic shock
Show all 20Show fewer
  • Major perioperative complication* occurring between CABG and randomization
  • 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

Trial locations and contacts

106 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

Jonathan Hupf contact

(212) 659-6862

Jonathan.Hupf@mountsinai.org

106 sites in 5 countries

United States51 sites, 35 recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

    China Green, chjgreen@med.umich.edu

    Jonathan Haft, MD

    Recruiting

  • Emory University

    Atlanta, Georgia, 30308

    Mary McBride, mary.mcbride@emory.edu

    Michael Halkos

    Recruiting

  • Piedmont Healthcare Inc.

    Atlanta, Georgia, 30309

    Amy Autry-Bush, Amy.Autry-Bush@piedmont.org

    Vinod Thourani, MD

    Recruiting

  • Medical Center of Aurora

    Aurora, Colorado, 80012

    Active, not recruiting

  • University of Maryland

    Baltimore, Maryland, 21201

    Kaitlyn Masih, KMasih@som.umaryland.edu

    Howard Massey, MD

    Recruiting

  • Johns Hopkins

    Baltimore, Maryland, 21287

    Zyriah Robinson, zyriah.robinson@jhmi.edu

    Hamza Aziz

    Recruiting

  • Suburban Hospital

    Bethesda, Maryland, 20814

    Active, not recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Anna Demelo, amdemelo@mgh.harvard.edu

    David D'Alessandro

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

    Amarri Harrison, aharrison7@bwh.harvard.edu

    Sary Aranki

    Recruiting

  • Boston Medical Center

    Boston, Massachusetts, 02118

    Active, not recruiting

  • University of Vermont

    Burlington, Vermont, 05401

    Fuyuki Hirashima, Fuyuki.Hirashima@uvmhealth.org

    Amy Henderson, Amy.Henderson@uvmhealth.org

    Recruiting

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

    Robin Kelly, RLK5A@hscmail.mcc.virginia.edu)

    Adanna Akujuo

    Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

    Anna Marie Simmons, SIMMONA8@ccf.org

    A Marc Gillinov

    Recruiting

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

    Active, not recruiting

  • Western Connecticut Hospital Systems

    Danbury, Connecticut, 06810

    Active, not recruiting

  • Duke University

    Durham, North Carolina, 27710

    Shelly Fincannon, shelly.fincannon@duke.edu

    Brittany Zwischenberger, MD

    Recruiting

  • Inova Health

    Falls Church, Virginia, 22042

    Active, not recruiting

  • Lutheran Medical Center

    Fort Wayne, Indiana, 46825

    Active, not recruiting

  • Northwell Health System

    Great Neck, New York, 11023

    Effe Mihelis, emihelis@northwell.edu

    Nirav Patel

    Recruiting

  • East Carolina University

    Greenville, North Carolina, 27858

    Eddie Hill, hille19@ecu.edu

    Shahab A. Akhter

    Recruiting

  • University of Pittsburgh Medical Center

    Hermitage, Pennsylvania, 16148

    Withdrawn

  • Baylor College of Medicine

    Houston, Texas, 77030

    Ricardo A Garnica, Ricardo.AvendanoGarnica@bcm.edu

    Todd Rosengart

    Recruiting

  • Michael E. DeBakey VA Medical Center

    Houston, Texas, 77030

    Pawel Kolodziejski, Pawel.Kolodziejski@va.gov

    Lorraine Cornwell

    Recruiting

  • Indiana University

    Indianapolis, Indiana, 46202

    Active, not recruiting

  • Ascension St. Vincent

    Indianapolis, Indiana, 46260

    Active, not recruiting

  • Mid America Health Institute

    Kansas City, Missouri, 64111

    Rosann M Gans, rgans@saint-lukes.org

    Keith Allen

    Recruiting

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03766

    Pauline Sirrell, Pauline.Sirrell@hitchcock.org

    Henry Tannous

    Recruiting

  • CHI St. Vincent, Arkansas

    Little Rock, Arkansas, 72205

    Lynn Bass, lynn.bass@commonspirit.org

    Thurston Bauer

    Recruiting

  • University of Southern California

    Los Angeles, California, 90033

    Ed Lozano, edwardlo@med.usc.edu

    Vaughn Starnes, MD

    Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

    Vanessa Wilson, Vanessa.Wilson@cshs.org

    Joanna Chikwe, MD

    Recruiting

  • University of Wisconsin

    Madison, Wisconsin, 53792

    Active, not recruiting

  • West Virginia University

    Morgantown, West Virginia, 26506

    Kimberly Quedado, kq10006@wvumedicine.org

    Vinay Badhwar

    Recruiting

  • Intermountain CV Research

    Murray, Utah, 84107

    Erika Hummel, erika.hummel@imail.org

    Stephen McKellar, MD

    Recruiting

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

    Annemarie Detoro, annemarie.detoro@hmhn.org

    Kourosh Asgarian, DO

    Recruiting

  • Yale Medicine

    New Haven, Connecticut, 06520-8039

    Fadi Al-Daoud, fadi.aldaoud@yale.edu

    Margaret Leiss, Margaret.leiss@yale.edu

    Recruiting

  • Ochsner Clinic

    New Orleans, Louisiana, 70121

    Nicolle Scholl, nicolle.scholl@ochsner.org

    P. Eugene Parrino

    Recruiting

  • The Mount Sinai Hospital

    New York, New York, 10029

    Withdrawn

  • Columbia University Medical Center

    New York, New York, 10032

    Amanda Alonso, aa2974@cumc.columbia.edu

    Michael Argenziano

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Mary Lou Mayer, MaryLou.Mayer@uphs.upenn.edu

    Michael Acker

    Recruiting

  • Allegheny Health Network

    Pittsburgh, Pennsylvania, 15212

    Active, not recruiting

  • Baylor Research Institute

    Plano, Texas, 75093

    Kristen Chionh, Kristen.Chionh@BSWHealth.org

    Michael DiMaio, MD

    Recruiting

  • Maine Medical Center

    Portland, Maine, 04102

    Monica Palmeri, Monica.Palmeri@mainehealth.org)

    Ansar Hassan

    Recruiting

  • WakeMed

    Raleigh, North Carolina, 27610

    Withdrawn

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Jennifer Martin, Martin.Jennifer2@mayo.edu

    Paul Tang

    Recruiting

  • University of Utah

    Salt Lake City, Utah, 84112

    Ashley Elmer, Ashley.Elmer@hsc.utah.edu

    Craig Selzman

    Recruiting

  • Baystate Health

    Springfield, Massachusetts, 01199

    Active, not recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    James Hermeyer, hermeyer.j@wustl.edu

    Tsuyoshi Kaneko, MD

    Recruiting

  • Stanford University

    Stanford, California, 94305

    Tiffany Flores, tflores2@stanford.edu

    Jack Boyd

    Recruiting

  • Montefiore Medical Center

    The Bronx, New York, 10467

    Magdalena Mamczur-Madry, RN, BSN, MS, ACRP-CP, mmamczur@montefiore.org

    Daniel Goldstein, MD

    Recruiting

  • Ascension St. John

    Tulsa, Oklahoma, 74103

    Active, not recruiting

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

    Katharine Mahoney, Katharine.E.Mahoney@medstar.net

    Christian Shults, MD

    Recruiting

Other trials in United States

Germany25 sites, 25 recruiting

  • Kerckhoff Klinik, Bad Nauheim

    Bad Nauheim

    Kathrin Knorz, k.knorz@kerckhoff-klinik.de

    Yeong-Hoon Choi

    Recruiting

  • Clinic Bad Neustadt - Medical Center for Heart and Vascular Diseases

    Bad Neustadt an der Saale

    Katharina Schoenrath, kschoenrath@dhzb.de

    Anno Diegeler

    Not yet recruiting

  • HDZ-NRW Bad Oeynhausen

    Bad Oeynhausen

    Heike Windhagen, ch-studien@dhz-nrw.de

    Kavous Hakim-Meibodi, MD

    Not yet recruiting

  • University Heart Center Hamburg

    Berlin, Brandenburg, 11353

    Jutta Nogal, j.nogal@uke.de

    Lennard Conradi, MD

    Not yet recruiting

  • Heart Center Leipzig

    Berlin, Brandenburg, 13347

    Michael Borger, MD, Michael.Borger@helios-gesundheit.de

    Maren Zieger, Maren.Zieger@leipzig-heart.de

    Recruiting

  • Charité Berlin - Benjamin Franklin Campus

    Berlin

    Ulf Landmesser, MD, ulf.landmesser@charite.de

    Ulf Landmesser, MD

    Not yet recruiting

  • Charité Berlin - Rudolf Virchow Campus

    Berlin

    Burkert Pieske, MD, burkert.pieske@charite.de

    Burkert Pieske, MD

    Not yet recruiting

  • German Heart Center Berlin

    Berlin

    Mirjam Gördes, mirjam.goerdes@dhzc-charite.de

    Stephan Jacobs, MD

    Recruiting

  • University Hospital Bonn

    Bonn

    Ben Kraushaar, ben.kraushaar@ukbonn.de

    Farhad Bakhtiary

    Recruiting

  • Medical Center Braunschweig

    Braunschweig

    Yessica Peglau, j.peglau@klinikum-braunschweig.de

    Wolfgang Harringer, MD

    Not yet recruiting

  • Heinrich Heine University Düsseldorf

    Düsseldorf

    Sinje Reimers, sinje.reimers@med.uni-duesseldorf.de

    Alexander Assman, MD

    Recruiting

  • Frankfurt University Hospital

    Frankfurt

    Linda Kretzschmar, linda.kretzschmar@kgu.de

    Thomas Walther, MD

    Recruiting

  • University Medical Center Frankfurt

    Frankfurt

    Heike Strohschnitter, Heike.Strohschnitter@kgu.de

    Thomas Walther, MD

    Not yet recruiting

  • Heart Center, University of Freiburg

    Freiburg im Breisgau

    Gabriele Lechner, gabriele.lechner@uniklinik-freiburg.de

    Yasir Al-Hamami

    Recruiting

  • University Medical Center Göttingen

    Göttingen, Lower Saxony

    Jessika Jordan, jessika.jordan@med.uni-goettingen.de

    Bernd Danner, MD

    Not yet recruiting

  • University Medical Center Halle

    Halle

    Andrea Lehmann, andrea.lehmann@uk-halle.de

    Gábor Szabó

    Recruiting

  • University Medical Center Heidelberg

    Heidelberg

    Christiane Miesel-Groeschel

    Gábor Szabó, MD

    Not yet recruiting

  • University Medical Center Jena

    Jena, Thuringia

    Sabine Krauspe, sabine.krauspe@med.uni-jena.de

    Torsten Doenst, MD

    Recruiting

  • University Medical Center Schleswig-Holstein Kiel

    Kiel

    Beke Sarrahs, beke.sarrahs@uksh.de

    Assad Haneya, MD

    Not yet recruiting

  • University Medical Center Schleswig-Holstein Lübeck

    Lübeck

    Jessika Schmidt, jessika.schmidt@uksh.de

    Stefan Klotz, MD

    Not yet recruiting

  • University Hospital Magdeburg

    Magdeburg

    Esther Meyer, esther.meyer@med.ovgu.de

    George Awad

    Recruiting

  • German Heart Center Munich

    Munich

    Stephani Simon, simons@dhm.mhn.de

    Markus Krane, MD

    Not yet recruiting

  • Medical Center of the Ludwig-Maximilians-University Munich

    Munich

    Christian Hagl, MD, christian.hagl@med.uni-muenchen.de

    Christian Hagl, MD

    Not yet recruiting

  • University of Oldenburg

    Oldenburg

    Melanie Kreitlow, kreitlow.melanie@klinikum-oldenburg.de

    Andreas Martens

    Recruiting

  • Hospital of the Brothers of Mercy Trier

    Trier

    Daniela Donovan, D.Donovan@bbtgruppe.de

    Terence J Donovan

    Recruiting

Other trials in Germany

United Kingdom17 sites, 10 recruiting

  • Belfast Health and Social Care Trust

    Belfast, Northern Ireland

    Active, not recruiting

  • Blackpool Teaching Hospitals NHS Foundation Trust

    Blackpool

    Ronald Manuel, ronald.manuel@nhs.net

    Mohamad Bittar, MD

    Recruiting

  • University Hospitals Bristol NHS Foundation Trust

    Bristol, BS1 3NU

    Emma Hopkins, emma.hopkins@uhbristol.nhs.uk

    Hunaid Vohra

    Recruiting

  • Royal Papworth Hospital NHS Foundation Trust

    Cambridge

    Active, not recruiting

  • Hull University Teaching Hospitals NHS Trust

    Cottingham, HU16 5JQ

    Active, not recruiting

  • University Hospitals of Leicester NHS Trust

    Leicester

    Active, not recruiting

  • Liverpool Heart and Chest Hospital NHS Foundation Trust

    Liverpool, England

    Andrew Muir

    Bilal Kirmani

    Recruiting

  • Barts Health NHS Trust

    London, England

    Martin Yates

    Recruiting

  • Imperial College Healthcare NHS Trust

    London, England

    Dimple Dixit, dimple.dixit@nhs.net

    Prakash P Punjabi

    Recruiting

  • South Tees Hospitals NHS Foundation Trust

    Middlesbrough

    Lynn Whitehouse, lynn.whitehouse@nhs.net

    Ralph White

    Recruiting

  • Nottingham University Hospitals NHS Trust

    Nottingham

    Pamela Anderson, pamela.anderson@nuh.nhs.uk

    Anas Boulemden

    Recruiting

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 9DU

    Active, not recruiting

  • University Hospitals Plymouth NHS Trust

    Plymouth

    Active, not recruiting

  • Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield

    Active, not recruiting

  • University Hospital Southampton NHS Foundation Trust

    Southampton

    Dimitrios Pousios

    Recruiting

  • Royal Wolverhampton NHS Trust

    Wolverhampton, England

    John S Billing

    Recruiting

  • University Hospitals Sussex NHS Foundation Trust

    Worthing, BN11 2DH

    Dawn Martinez, dawn.diokno@nhs.net

    Istiaq M Ahmed

    Recruiting

Other trials in United Kingdom

Canada9 sites, 8 recruiting

  • University of Alberta Hospital

    Edmonton, Alberta, T6G2B7

    Tracy Jordan, Tracy.Jordan@albertahealthservices.ca

    Celine Balay, cbalay@ualberta.ca

    Recruiting

  • London Health Sciences Centre

    London, Ontario, N6A 5A5

    Stephanie Fox, Stephanie.Fox@lhsc.on.ca

    Michael Chu

    Recruiting

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

    Alexandre Bergeron, alexandre.bergeron.Icm@icm-mhi.org

    Denis Bouchard, MD

    Recruiting

  • Centre Hospitalier de l'Université de Montréal

    Montreal, Quebec, H2W 1T8

    Joannie Dionne, joannie.dionne.chum@ssss.gouv.qc.ca

    Nicolas Noiseux

    Recruiting

  • Hôpital du Sacré-Cœur de Montréal

    Montreal, Quebec, H4J 1C5

    Withdrawn

  • University of Ottawa Heart Institute

    Ottawa

    Alice Black, AlBlack@ottawaheart.ca

    Pierre Voisine, MD

    Not yet recruiting

  • Hôpital Laval

    Québec, G1V 4G5

    François Dagenais, francois.dagenais@fmed.ulaval.ca

    Nathalie Gagne, Nathalie.Gagne@criucpq.ulaval.ca

    Recruiting

  • Sunnybrook Hospital

    Toronto, Ontario, M4N 3M5

    Reena Karkhanis, Reena.Karkhanis@sunnybrook.ca

    Stephen Fremes

    Recruiting

  • Toronto General Hospital

    Toronto

    Shakira Christie, Shakira.Christie@uhn.ca

    Terrance Yau

    Not yet recruiting

Other trials in Canada

Brazil4 sites

  • Hospital Samaritano Paulista

    São Paulo

    Active, not recruiting

  • Hospital Universitário São Francisco na Providência de Deus

    São Paulo

    Active, not recruiting

  • Instituto de Pesquisa Clínica de Campinas

    São Paulo

    Active, not recruiting

  • Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP-InCor-HCFMUSP

    São Paulo

    Active, not recruiting

Other trials in Brazil

About this study

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.

Read the 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.

Being tested
Antiplatelet-only strategy, Oral Anticoagulant plus background antiplatelet therapy
Keywords
Anticoagulation, Antiplatelet Therapy, Post Operative Atrial Fibrillation
Medical subject headings
Atrial Fibrillation, Stroke, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Antiplatelet-only strategyDrug

    Aspirin 75-325 mg once-daily or a P2Y12-inhibitor (clopidogrel or ticagrelor)

  • Oral Anticoagulant plus background antiplatelet therapyDrug

    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)

Study groups in NCT04045665
Study groupRoleWhat they receive
Antiplatelet TherapyActive comparatorAntiplatelet-only strategy
Receives: Drug: Antiplatelet-only strategy
Oral AnticoagulantActive comparatorOAC-based strategy
Receives: Drug: Oral Anticoagulant plus background antiplatelet therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: up to 180 days after randomization

  2. Any BARC type 3 or 5

    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

    1. 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
    2. Intracranial hemorrhage confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision. type 5: a. Probable fatal bleeding
    3. Definite fatal bleeding (overt or autopsy or imaging confirmation)

    Measured: 90 days after randomization

Secondary outcomes (11)

  1. Net clinical benefit (NCB)

    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.

    Measured: 90 days after randomization

  2. Number of participants with Ischemic Stroke event

    Measured: 180 days after randomization

  3. Number of participants with TIA event

    Measured: 180 days after randomization

  4. Number of participants with MI event

    Measured: 180 days after randomization

  5. Number of participants with systematic arterial thromboembolism event

    Measured: 180 days after randomization

  6. Number of participants with venous thromboembolism event

    Measured: 180 days after randomization

  7. Number of cardiovascular mortalities

    Measured: up to 180 days after randomization

  8. Number of non-cardiovascular mortalities

    Measured: up to 180 days after randomization

  9. The incidence of BARC 2 bleeding at 90 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

    Measured: 90 days after randomization

  10. The incidence of BARC 2 bleeding at 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

    Measured: 180 days after randomization

  11. Number of cardiac arrhythmias

    Number of cardiac arrhythmias including recurrent symptomatic or asymptomatic AF requiring medical attention

    Measured: 180 days after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2019
  2. Study start13 Dec 2019
  3. Primary completion31 Aug 2026 (estimated)
  4. Study completion31 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a multicenter randomized clinical trial comparing OAC to no-OAC in addition to concomitant antiplatelet therapy in 3,200 eligible patients who develop POAF after isolated CABG. The trial will be conducted by the Cardiothoracic Surgical Trials Network (CTSN), the German Society for Thoracic and Cardiovascular Surgery (DGTHG) and other European sites, the United Kingdom and Brazil..
Masking
None (open label)
Enrolment
3,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04045665
Sponsor's protocol ID
GCO 08-1078
Other IDs
2U01HL088942-12
Acronym
PACES
Status last verified
Jun 2026
First submitted
2 Aug 2019
Last updated
26 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Publications

  • Budd AN, Kertai MD, Wyler von Ballmoos MC, Raphael J, Ghadimi K, Levy JH, Shore-Lesserson LJ, Mazzeffi MA, Sniecinski RM, Tanaka KA, Bolliger D, Abdalla M, Ural KG, Upchurch PA, Rozental O, Hunter CB, Seibert AR, Klick JC, Carroll D, Lobner K, Hensley NB. Management of Direct Oral Anticoagulants in Adult Patients Undergoing Cardiac Surgery: A Joint Consensus Statement by the Society of Cardiovascular Anesthesiologists and the Society of Thoracic Surgeons. Anesth Analg. 2026 Apr 1;142(4):668-681. doi: 10.1213/ANE.0000000000007868. Epub 2026 Jan 29.

    PubMed 41609362

  • Boriani G, Imberti JF, McIntyre WF, Mei DA, Healey JS, Schnabel RB, Svennberg E, Camm AJ, Freedman B. Detection and management of postoperative atrial fibrillation after coronary artery bypass grafting or non-cardiac surgery: a survey by the AF-SCREEN International Collaboration. Intern Emerg Med. 2025 Apr;20(3):739-749. doi: 10.1007/s11739-025-03861-2. Epub 2025 Feb 8.

    PubMed 39921772

  • Taha A, Nielsen SJ, Bergfeldt L, Ahlsson A, Friberg L, Bjorck S, Franzen S, Jeppsson A. New-Onset Atrial Fibrillation After Coronary Artery Bypass Grafting and Long-Term Outcome: A Population-Based Nationwide Study From the SWEDEHEART Registry. J Am Heart Assoc. 2021 Jan 5;10(1):e017966. doi: 10.1161/JAHA.120.017966. Epub 2020 Nov 30.

    PubMed 33251914

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Antiplatelet-only strategy and Oral Anticoagulant plus background antiplatelet therapy in people with Atrial Fibrillation and Stroke, run by Icahn School of Medicine at Mount Sinai at 106 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 106 sites in United States, Germany, United Kingdom, Canada, Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jonathan Hupf ((212) 659-6862, Jonathan.Hupf@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04045665, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.

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