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Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG
NCT04045665 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 3,200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 946 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04045665 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Indiana, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04045665?
The interventions under investigation include: Antiplatelet-only strategy (DRUG), Oral Anticoagulant plus background antiplatelet therapy (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04045665?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 946 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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