Early Anti-Coagulation therapy in new onset atrial fibrillation after coronary artery bypass graft operation; Warfarin vs Rivaroxaban for stroke prevention

Early Anti-Coagulation therapy in new onset atrial fibrillation after coronary artery bypass graft operation; Warfarin vs Rivaroxaban for stroke prevention and risk of bleeding assessment: A randomized clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200304046696N1

Enrollment

1590

Registered

2020-03-18

Start date

2020-04-03

Completion date

Unknown

Last updated

2020-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Operative Atrial Fibrillation. Paroxysmal atrial fibrillation

Interventions

Intervention 1: Intervention group: Drug Warfarin administration. Intervention 2: Intervention group: Drug Rivaroxaban administration.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who undergone Isolated coronary artery bypass graft in Tehran Heart Center Two or more episodes of New Onset Atrial Fibrillation (each lasting > 20 minutes) or persistent atrial fibrillation lasting > 24 hours

Exclusion criteria

Exclusion criteria: History of allergy to study drugs History of recent stroke (within 1 month) before surgery or post-operation before initiation of study medications At least moderate Mitral or Aortic valve stenosis not repaired or replaced by surgery Recent (within 1 year) or ongoing pregnancy (Blood pregnancy test (b-HCG level) will be checked for young women at the beginning of the study) Any other indication for anticoagulation therapy (Including DVT, PTE, mechanical valve) Baseline INR > 1.7 History of atrial fibrillation before operation Postoperative bleeding before initiation of anticoagulation medications Glomerular filtration rate(GFR) < 30 ml/min

Design outcomes

Primary

Measure	Time frame
Stroke or Transient Ischemic Attack (TIA). Timepoint: Up to 30 days after discharge. Method of measurement: Clinical assessment, Imaging if needed (If neurological examination is favorable for stroke or TIA, the diagnosis will be confirmed by imaging (Brain CT_scan or MRI)).	—

Secondary

Measure	Time frame
Major Bleeding. Timepoint: Up to 30 days after discharge. Method of measurement: Physical Examination_ Bleeding which requires re-operation or other therapeutic intervention for bleeding assessment (e.g colonoscopy, endoscopy and urologic procedures for hematuria), development of any intracranial bleeding (Diagnosis will be confirmed by Brain CT_scan or Magnetic resonance Imaging), transfusion > 2 units of blood after drug initiation.	—

Measure

Time frame

Major Bleeding. Timepoint: Up to 30 days after discharge. Method of measurement: Physical Examination_ Bleeding which requires re-operation or other therapeutic intervention for bleeding assessment (e.g colonoscopy, endoscopy and urologic procedures for hematuria), development of any intracranial bleeding (Diagnosis will be confirmed by Brain CT_scan or Magnetic resonance Imaging), transfusion > 2 units of blood after drug initiation.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMojgan Ghavami

Tehran University of Medical Sciences

ghavami_mojgan69@yahoo.com+98 21 8802 9256

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 6, 2026