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Clinical trial

The Effect of Silymarin on the Prevention of Atrial Fibrillation After Coronary Artery Bypass Graft Surgery

ID
Name
661-1/1
Description
The study is a prospective, randomized, controlled trial to assess the effects of silymarin on the occurrence of postoperative atrial fibrillation after coronary artery bypass graft surgery.
Trial arms
Trial start
2023-01-01
Estimated PCD
2025-01-01
Trial end
2025-07-01
Status
Recruiting
Phase
Early phase I
Treatment
Silymarin
Subjects of the experimental group will receive silymarin (capsules containing 100 mg silymarin, expressed as silibinin) three days preoperatively. The dose they receive will be the recommended dose for the registered indications (400 mg daily, orally, divided into two doses).
Arms:
Experimental group
Size
160
Primary endpoint
Number of participants with postoperative atrial fibrillation
4 days
Eligibility criteria
Inclusion Criteria: * scheduled for elective CABG surgery using cardiopulmonary bypass * first cardiac surgery * left ventricular ejection fraction \> 35% * less than moderate mitral regurgitation Exclusion Criteria: * preoperative atrial fibrillation * previous history of interventionally treated arrhythmias * end-stage renal disease requiring hemodialysis * chronic inflammatory and neoplastic diseases
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 160, 'type': 'ESTIMATED'}}
Updated at
2023-11-07

1 organization

1 product

1 indication

Organization
University of Novi Sad
Product
Silymarin
Indication
Atrial Fibrillation New Onset