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NCT06802926 | NOT YET RECRUITING | CABG

Pilot Trial of Colchicine for Graft Failure in CABG
Sponsor:

Ruisin Hospital

Information provided by (Responsible Party):

Zhu Yunpeng

Brief Summary:

The goal of this pilot trial is to to evaluate the preliminary effect of oral colchicine therapy on graft outcomes in patients underwent primary isolated CABG. The main questions it aims to answer is: 1. Whether the oral colchicine therapy may reduce the failure outcome of grafts after CABG. 2. Whether it is feasible to construct a muticenter powered trial to test the superiority hypothesis. Researchers will compare colchicine to none to see if colchicine works. Participants will 1. Take oral colchicine (0.5mg daily) therapy for 12 months after CABG. 2. Clinical follow-up at Month 1, 6, and 12 after CABG. 3. Protocol-driven CCTA at Week 1 and Month 12 after CABG.

Condition or disease

CABG

Graft Failure

Colchicine

Intervention/treatment

Colchicine

Phase

PHASE4

Study Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : A Single Center Pilot Trial of Preliminary Effect of Colchicine on Graft Failure in Patients Underwent CABG
Actual Study Start Date : 2025-07
Estimated Primary Completion Date : 2027-06
Estimated Study Completion Date : 2027-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Age≥18 years old，
  • * Any sex，
  • * Signed informed consent，
  • * Within 3 days after a successful isolated CABG
Exclusion Criteria
  • * Allergy,
  • * Hematopoietic dysfunction,
  • * Moderate to severe hepatic dysfunction,
  • * Moderate to severe renal dysfunction.
Pilot Trial of Colchicine for Graft Failure in CABG

Location Details

NCT06802926

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

China,

Ru I entered hospital Shanghai J i AO tong university school of medicine

Shanghai, China,