NCT06114719

Brief Summary

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 2, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

December 4, 2024

Status Verified

December 1, 2024

Enrollment Period

1.7 years

First QC Date

October 29, 2023

Last Update Submit

December 3, 2024

Conditions

Atrial Fibrillation New Onset

Keywords

cardiac surgerypostoperative atrial fibrillationsilymarin

Outcome Measures

Primary Outcomes (1)

  • Number of participants with postoperative atrial fibrillation

    Occurrence of postoperative atrial fibrillation lasting at least 30 s on a rhythm strip or 12-lead ECG

    4 days

Secondary Outcomes (5)

  • ICU length of stay

    30 days

  • Hospital length of stay

    30 days

  • Postoperative complications

    30 days

  • Blood concentration of white blood cells

    4 days

  • Blood concentration of C-reactive protein

    4 days

Study Arms (2)

Experimental group

EXPERIMENTAL

Silymarin 400 mg daily, orally, divided into two doses, for three days preoperatively

Drug: Silymarin

Control group

NO INTERVENTION

Optimal standard therapy

Interventions

SilymarinDRUG

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).

Experimental group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • scheduled for elective CABG surgery using cardiopulmonary bypass
  • first cardiac surgery
  • left ventricular ejection fraction \> 35%
  • less than moderate mitral regurgitation

You may not qualify if:

  • preoperative atrial fibrillation
  • previous history of interventionally treated arrhythmias
  • end-stage renal disease requiring hemodialysis
  • chronic inflammatory and neoplastic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Cardiovascular Diseases of Vojvodina

Kamenitz, 21204, Serbia

Location

MeSH Terms

Interventions

Silymarin

Intervention Hierarchy (Ancestors)

FlavonolignansFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 29, 2023

First Posted

November 2, 2023

Study Start

January 1, 2023

Primary Completion

September 1, 2024

Study Completion

September 30, 2024

Last Updated

December 4, 2024

Record last verified: 2024-12

Locations

SE(1)