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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04045665
The ClinicalTrials.gov registry entry for NCT04045665 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 3,200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,009-participant average among 454 other Stroke trials with a reported enrollment target (73% lower). The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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.
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Related
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