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NotablePrimary and study completion dates: Jun 30, 2025 to Aug 31, 2026
Site details revised at 1 of 96 sites
v39
MinorStudy sites: 90 to 96v38
MinorStudy sites: 84 to 90v37
Show 35 earlier versionsHide 35 earlier versions
NotablePrimary endpoints revised (2)v36Show 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
MinorStudy sites: 76 to 79v35
NotablePhase: 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
MinorPrimary completion date: Dec 2024 to Jan 31, 2024
Study completion date: Dec 1, 2025 to Apr 30, 2024
v33
MinorStudy sites: 73 to 74v32
MinorSite details revised at 1 of 73 sitesv31
MinorStudy sites: 72 to 73v30
MinorStudy sites: 70 to 72v29
MinorStudy sites: 69 to 70v28
MinorStudy sites: 67 to 69v27
NotablePrimary 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
MinorStudy sites: 66 to 67v25
MinorSite details revised at 1 of 66 sitesv24
MinorSite details revised at 1 of 66 sitesv23
MinorStudy sites: 65 to 66v22
MinorSite details revised at 3 of 65 sitesv21
MinorSite details revised at 1 of 65 sitesv20
MinorStudy sites: 64 to 65v19
MinorStudy sites: 63 to 64v18
MinorStudy sites: 62 to 63v17
MinorSite details revised at 1 of 62 sitesv16
MinorStudy sites: 61 to 62v15
MinorStudy sites: 60 to 61v14
NotablePhase: Phase 3 to Phase 4v13
MinorSite details revised at 2 of 60 sitesv12
MinorSite details revised at 2 of 60 sitesv11
MinorStudy description expanded, about 11 words
Site details revised at 4 of 60 sites
Eligibility criteria expanded, about 2 words
v10
MinorStudy sites: 63 to 60v9
MinorSite details revised at 2 of 63 sitesv8
MinorSite details revised at 2 of 63 sitesv7
NotableTrial 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
MinorStart date: Nov 2019 to Dec 2019
Site contacts updated at 1 of 63 sites
v5
MinorStart date: Oct 2019 to Nov 2019v4
MinorStart date: Sep 30, 2019 to Oct 2019v3
MinorStudy sites: 62 to 63
Start date: Sep 1, 2019 to Sep 30, 2019
v2
MinorStudy 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.