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

Study acronym: PACES
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 26, 2026 (before its estimated August 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Trial sites expanded: 101 → 106 locationsv41
  2. Minor Study sites: 96 to 101v40
  3. Notable Primary and study completion dates: Jun 30, 2025 to Aug 31, 2026
    • Site details revised at 1 of 96 sites
    v39
  4. Minor Study sites: 90 to 96v38
  5. Minor Study sites: 84 to 90v37
Show 35 earlier versionsHide 35 earlier versions
  1. Notable Primary endpoints revised (2)v36 Show 5 more changesShow less
    • Study sites: 79 to 84
    • Primary completion date: Jan 31, 2025 to Jun 30, 2025
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: 10 to 11
    • Study description shortened, about 7 words
  2. Minor Study sites: 76 to 79v35
  3. Notable Phase: Phase 4 to Phase 3
    • Primary completion date: Jan 31, 2024 to Jan 31, 2025
    • Study sites: 74 to 76
    • Study completion date: Apr 30, 2024 to Jun 30, 2025
    v34
  4. Minor Primary completion date: Dec 2024 to Jan 31, 2024
    • Study completion date: Dec 1, 2025 to Apr 30, 2024
    v33
  5. Minor Study sites: 73 to 74v32
  6. Minor Site details revised at 1 of 73 sitesv31
  7. Minor Study sites: 72 to 73v30
  8. Minor Study sites: 70 to 72v29
  9. Minor Study sites: 69 to 70v28
  10. Minor Study sites: 67 to 69v27
  11. Notable Primary completion date: Dec 2022 to Dec 2024
    • Study completion date: Dec 1, 2023 to Dec 1, 2025
    • Eligibility criteria shortened, about 13 words
    • Study description expanded, about 33 words
    v26
  12. Minor Study sites: 66 to 67v25
  13. Minor Site details revised at 1 of 66 sitesv24
  14. Minor Site details revised at 1 of 66 sitesv23
  15. Minor Study sites: 65 to 66v22
  16. Minor Site details revised at 3 of 65 sitesv21
  17. Minor Site details revised at 1 of 65 sitesv20
  18. Minor Study sites: 64 to 65v19
  19. Minor Study sites: 63 to 64v18
  20. Minor Study sites: 62 to 63v17
  21. Minor Site details revised at 1 of 62 sitesv16
  22. Minor Study sites: 61 to 62v15
  23. Minor Study sites: 60 to 61v14
  24. Notable Phase: Phase 3 to Phase 4v13
  25. Minor Site details revised at 2 of 60 sitesv12
  26. Minor Site details revised at 2 of 60 sitesv11
  27. Minor Study description expanded, about 11 words
    • Site details revised at 4 of 60 sites
    • Eligibility criteria expanded, about 2 words
    v10
  28. Minor Study sites: 63 to 60v9
  29. Minor Site details revised at 2 of 63 sitesv8
  30. Minor Site details revised at 2 of 63 sitesv7
  31. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 2019 to Dec 13, 2019
    • Site details revised at 63 of 63 sites
    v6
  32. Minor Start date: Nov 2019 to Dec 2019
    • Site contacts updated at 1 of 63 sites
    v5
  33. Minor Start date: Oct 2019 to Nov 2019v4
  34. Minor Start date: Sep 30, 2019 to Oct 2019v3
  35. Minor Study sites: 62 to 63
    • Start date: Sep 1, 2019 to Sep 30, 2019
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04045665
Lead Sponsor Icahn School of Medicine at Mount Sinai
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), Vanderbilt University Medical Center
Conditions
(from sponsor)
Atrial Fibrillation, Stroke, Bleeding
Related terms Atrial Fibrillation, Hemorrhage, Stroke
Enrollment 3,200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov