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Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG

NCT04045665 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3200

Last updated 2026-01-20

No results posted yet for this 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

Interventions

DRUG

Antiplatelet-only strategy

Aspirin 75-325 mg once-daily or a P2Y12-inhibitor (clopidogrel or ticagrelor)

DRUG

Oral Anticoagulant plus background antiplatelet therapy

OAC with vitamin K antagonist (VKA) with international normalized ratio (INR) target 2-3 or any approved direct oral anticoagulant OR apixaban, rivaroxaban, edoxaban or dabigatran) in addition to background antiplatelet therapy with aspirin 75-325mg once-daily or a P2Y12-inhibitor (clopidogrel or ticagrelor)

Sponsors & Collaborators

Principal Investigators

  • Annetine C Gelijns, PhD · Icahn School of Medicine at Mount Sinai

  • Marc Gillinov, MD · The Cleveland Clinic

  • John Alexander, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-13
Primary Completion
2026-08-31
Completion
2026-08-31
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Germany
  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04045665 on ClinicalTrials.gov