Preventing formation of blood clots due to atrial fibrillation, a cardiac arrhythmia that first occurred after coronary bypass surgery, with the help of anticoagulant medications.

Phase 1

• Conditions: ew-Onset Post-Operative Atrial Fibrillation afterCABG; MedDRA version: 20.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2021-005022-18-DE
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-14
• Last Update Posted: 5 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 3200

Inclusion Criteria

1. Patients of age =18 years who undergo isolated CABG for coronary
artery disease
2. POAF that persists for >60 minutes or is recurrent (more than one
episode) within 7 days after the index CABG
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2000

Exclusion Criteria

1. Clinical history of either permanent, persistent or paroxysmal atrial
fibrillation
2. Any pre-existing clinical indication for long-term OAC
3. Any absolute contraindication to OAC
4. Planned use of post-operative dual antiplatelet therapy (DAPT)
5. Cardiogenic shock
6. Major perioperative complication occurring between CABG and
randomization
7. Concomitant left atrial appendage closure during CABG
8. Concomitant valve surgery during CABG or prior valve surgery (including aortic,
mitral, tricuspid or pulmonary)
9. Concomitant mitral valve annuloplasty during CABG
10. Concomitant carotid artery endarterectomy during CABG
11. Concomitant aortic root replacement during CABG
12. Concomitant surgery for AF during CABG
13. Liver cirrhosis or Child-Pugh Class C chronic liver disease
14. Pharmacologic therapy with an investigational drug or device
within 30-days prior to randomization or plan to enroll patient in an
investigational drug or device trial during participation in this trial
15. Pregnancy at the time of randomization
16. Unable or unwilling to provide informed consent
17. Unable or unwilling to comply wit the study treatment and followup
18. Existence of underlying disease that limits life expectancy to less
than one year

Added for European Trial sites:
19. women of childbearing potential (within two years after the last
spontaneous menstruation) without effective contraceptive measures
(Implanon, injections, oral contraceptives, intrauterine devices,
vasectomized partner) during study participation.
(Participants using hormone-based preparations must be informed about possible
informed about possible interactions with the study medication).
be informed).
20. participation in other interventional studies
21. patients under legal supervision or guardianship.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified