Pilot Trial of Colchicine for Graft Failure in CABG
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age≥18 years old，
Any sex，
Signed informed consent，
Within 3 days after a successful isolated CABG
Disqualifiers
Allergy,
Hematopoietic dysfunction,
Moderate to severe hepatic dysfunction,
Moderate to severe renal dysfunction.
Trial design
Design model
Parallel
Treatments tested in this trial
Colchicine
DrugOral Colchicine 0.5mg qd for 1 year
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: ColchicineExperimental treatment 1 intervention
Group B: Blank controlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
The Graft Failure Rate at 1 year
A protocol-driven CCTA will be used to evaluate the graft outcome at 1 year after CABG. Fitzgibbon Grade B/S/O is definned as graft failure.
Time frame
at 1 year post-CABGSecondary outcomes
1
The time to first 5-point Major Adverse Cardiovascular Event (MACE-5)
MACE-5 is a composite of all-cause death, myocardial infarction, stroke, unplanned revascularization, and rehospitalization due to unstable angina.
Time frame
within 1 year post-CABG2
The rate of new perioperative atrial fibrillationat (PAF) within 1 week after CABG
PAF will be detected through continuous electrocardiographic monitoring.
Time frame
within 7 days post-CABGSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov