NCT04045665 Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG
| NCT ID | NCT04045665 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,200 participants |
| Start Date | 2019-12-13 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 3,200 participants in total. It began in 2019-12-13 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Patients of age ≥18 years who undergo isolated CABG for coronary artery disease * POAF that persists for \>60 minutes or is recurrent (more than one episode) within 7 days after the index CABG surgery Exclusion Criteria: * Clinical history of either permanent, persistent or paroxysmal atrial fibrillation * Any pre-existing clinical indication for long-term OAC * Any absolute contraindication to OAC * Planned use of post-operative dual antiplatelet therapy (DAPT) a. This includes, but is not limited to, patients with recent PCI with drug-eluting or bare-metal stent. * Cardiogenic shock * Major perioperative complication\* occurring between CABG and randomization a. including, but not limited to, stroke, TIA, MI, major bleeding (BARC type 4 bleeding), severe sepsis, renal failure requiring dialysis, or need for reoperation due to bleeding (e.g. pericardial tamponade). * Concomitant left atrial appendage closure during CABG * Concomitant valve surgery during CABG or
Frequently Asked Questions
Who can join the NCT04045665 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04045665 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 3,200 participants.
Is NCT04045665 currently recruiting?
Yes, NCT04045665 is actively recruiting participants. Visit ClinicalTrials.gov or contact Icahn School of Medicine at Mount Sinai to inquire about joining.
Where is the NCT04045665 trial being conducted?
This trial is being conducted at Little Rock, United States, Los Angeles, United States, Los Angeles, United States, Stanford, United States and 1 additional location.
Who is sponsoring the NCT04045665 clinical trial?
NCT04045665 is sponsored by Icahn School of Medicine at Mount Sinai. The trial plans to enroll 3,200 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.