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NCT04045665 · ClinicalTrials.gov registry record · Phase 3
Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG
A Phase 3 study of Stroke and Atrial Fibrillation, sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 3,200
- Enrollment target
- 20
- Study locations
NCT04045665: Recruiting Phase 3 study of Stroke and Atrial Fibrillation, sponsored by Icahn School of Medicine at Mount Sinai.
NCT04045665 is a Phase 3 study of Stroke and Atrial Fibrillation that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 3,200 participants, below the 12,009-participant average among 454 other Stroke trials with a reported enrollment target (73% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04045665, a Phase 3 study of Stroke and Atrial Fibrillation, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 3,200 participants
- Enrollment target
- 20
- Study locations
Study 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 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Antiplatelet-only strategy
- DRUG Oral Anticoagulant plus background antiplatelet therapy
Study Locations (20)
California
- University of Southern California - Los Angeles
- Cedars-Sinai Medical Center - Los Angeles
- Stanford University - Stanford
Indiana
- Lutheran Medical Center - Fort Wayne
- Indiana University - Indianapolis
- Ascension St. Vincent - Indianapolis
Maryland
- University of Maryland - Baltimore
- Johns Hopkins - Baltimore
- Suburban Hospital - Bethesda
Connecticut
- Western Connecticut Hospital Systems - Danbury
- Yale Medicine - New Haven
Georgia
- Emory University - Atlanta
- Piedmont Healthcare Inc. - Atlanta
Massachusetts
- Massachusetts General Hospital - Boston
- Brigham and Women's Hospital - Boston
Arkansas
- CHI St. Vincent, Arkansas - Little Rock
Colorado
- Medical Center of Aurora - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,200 participants |
| Start Date | 2019-12-13 |
| Est. Completion | 2026-08-31 |
| Phase | Phase 3 |
What NCT04045665 shows while recruiting
NCT04045665 is an interventional study that assigns participants to a tested intervention. Its 3,200 participants enrollment target places it among the larger protocols in the corpus, below the 12,009-participant average among 454 other Stroke trials with a reported enrollment target (73% lower).
The record links to 3 conditions, with Stroke appearing as the primary indexed condition, and to 2 interventions - of which Antiplatelet-only strategy is the first listed.
NCT04045665 names 20 study sites across 11 states, led by California, Indiana, Maryland.
Frequently Asked Questions
What is clinical trial NCT04045665 about?
NCT04045665 is a clinical study titled "Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG". 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 co...
What is the current status of trial NCT04045665?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 3,200 participants. The study started on 2019-12-13. Estimated completion is 2026-08-31.
What conditions does trial NCT04045665 study?
This clinical trial studies the following conditions: Stroke, Atrial Fibrillation, Bleeding.
What interventions are being tested in trial NCT04045665?
The interventions under investigation include: Antiplatelet-only strategy (DRUG), Oral Anticoagulant plus background antiplatelet therapy (DRUG).
Who is sponsoring clinical trial NCT04045665?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04045665 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stroke
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04045665's enrollment target sits among peer trials
3,200 20th of 454 higher than 435 of 454 other Stroke trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stroke trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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