CABGPhase 4CoCAB-PilotNCT06802926
Pilot Trial of Colchicine for Graft Failure in CABG
A Phase 4 study testing Colchicine in people with CABG and Graft Failure, run by Ruijin Hospital at 1 site in China.
Trial summary
This is a single-center, prospective, randomized, open-label, assessor-blinded, blank-controlled exploratory (pilot) trial evaluating the feasibility of oral colchicine after coronary artery bypass grafting (CABG). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CABG, Graft Failure, Colchicine
- What is being tested?
- Colchicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 29 Dec 2025to Dec 2028
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥18 years old，
- Any sex，
- Signed informed consent，
- Within 3 days after a successful isolated CABG
Who cannot join
- Allergy,
- Hematopoietic dysfunction,
- Moderate to severe hepatic dysfunction,
- Moderate to severe renal dysfunction.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai
Yunepng Zhu, MD, 02164370045, zyp12220@rjh.com.cn
About this study
Official title: A Single Center Pilot Trial of Preliminary Effect of Colchicine on Graft Failure in Patients Underwent CABG
This is a single-center, prospective, randomized, open-label, assessor-blinded, blank-controlled exploratory (pilot) trial evaluating the feasibility of oral colchicine after coronary artery bypass grafting (CABG). Graft failure and cardiovascular events remain common after CABG, and the anti-inflammatory drug colchicine has shown cardiovascular benefit in chronic coronary disease but has not been adequately studied after CABG.
Approximately 100 adults (aged 18 years and older, any sex) who have undergone first-time isolated CABG, are clinically stable within 3 days after surgery, and are able to take oral medications will be enrolled. Participants will be randomized 1:1 to receive oral colchicine 0.5 mg once daily, initiated within 3 days after surgery and continued for up to 1 year, or no colchicine (blank control).
Read more
The primary objective is to assess the feasibility of oral colchicine after CABG, including participant recruitment rate, informed consent rate, treatment adherence, 1-year follow-up completion rate (coronary CT angiography review rate), and safety acceptability, to provide feasibility evidence and sample size estimation parameters for a future multicenter confirmatory randomized controlled trial. Secondary and exploratory objectives include preliminary comparisons of 1-year graft failure (Fitzgibbon B/S/O grades), major adverse cardiovascular events (MACE-5), serious complications of interest, new-onset perioperative atrial fibrillation/flutter, changes in high-sensitivity C-reactive protein and neutrophil-to-lymphocyte ratio, and the incidence of diarrhea and serious infection.
Each participant will be followed for 1 year after surgery.
- Conditions
- CABG, Graft Failure, Colchicine
- Being tested
- Colchicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
Oral Colchicine 0.5mg qd for 1 year
| Study group | Role | What they receive |
|---|---|---|
| Colchicine | Experimental | Oral Colchicine 0.5mg qd for 1 year Receives: Drug: Colchicine |
| Blank control | No intervention | No Oral Colchicine therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant recruitment rate
Average number of participants randomized per month, from start of enrollment to completion of enrollment. Go/no-go (traffic-light) thresholds: Green ≥12 per month; Amber 7-11 per month; Red <7 per month.
Measured: From start of enrollment through completion of enrollment (approximately 1 year)
Informed consent success rate
Number of participants who signed informed consent divided by number screened. Go/no-go (traffic-light) thresholds: Green ≥60% and ≤85%; Amber ≥45%and<60%; Red <45% or >85%.
Measured: From screening through completion of enrollment (approximately 1 year)
Treatment adherence rate
Proportion of participants who are adherent to the assigned treatment (number of adherent participants divided by total number of participants). Go/no-go (traffic-light) thresholds: Green ≥95%; Amber ≥85%and<95%; Red <85%.
Measured: From randomization through 1 year post-CABG (end of study follow-up)
1-year CCTA follow-up completion rate
Proportion of participants who complete coronary CT angiography (CCTA) graft assessment at 1 year after CABG surgery. Go/no-go (traffic-light) thresholds: Green ≥90%; Amber ≥80% and <90%; Red <80%.
Measured: From randomization through 1 year post-CABG (end of study follow-up)
Safety acceptability
Incidence of colchicine-related serious adverse events (SAEs). Go/no-go (traffic-light) thresholds: Green ≤4%; Amber >4% and ≤8%; Red >8%.
Measured: From randomization through 1 year post-CABG (end of study follow-up)
Secondary outcomes (6)
1-year Graft failure rate
Incidence of graft failure at 1 year after CABG, assessed by coronary CT angiography (CCTA). Graft failure is defined as modified Fitzgibbon Grade B (stenosis ≥50%), Grade S (string sign), or Grade O (occlusion).
Measured: at 1 year post-CABG
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.
Measured: within 1 year post-CABG
30-days incidence of serious complications
Incidence of pre-specified serious complications within 30 days after surgery, including: cardiac arrest (requiring cardiopulmonary resuscitation); reoperation (bleeding-related or other causes); incision complications (superficial or deep); pulmonary infection (requiring prolonged or escalated antibiotic therapy); respiratory failure (requiring re-intubation or tracheostomy); permanent pacemaker implantation; major gastrointestinal bleeding; and new-onset renal failure (requiring dialysis).
Measured: Within 30 days after surgery
1-week new perioperative atrial fibrillationat (PAF) rate
PAF will be detected through continuous electrocardiographic monitoring.
Measured: within 7 days post-CABG
Change in high-sensitivity C-reactive protein (hs-CRP) and neutrophil-to-lymphocyte ratio (NLR)
Changes in hs-CRP and NLR from baseline at 7 days, 30 days, 6 months, and 12 months after surgery, reported as absolute change and percentage change from baseline.
Measured: Baseline through 1 year post-CABG
Incidence of diarrhea and serious infection
Incidence of diarrhea (drug-related change in bowel habits, such as increased frequency or loose stools) and serious infection (infection confirmed by microbiological, pathological, and/or imaging examination and requiring intravenous antibiotics) within 1 year after surgery.
Measured: Within 1 year post-CABG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start29 Dec 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CABGStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu yunpeng, Ruijin Hospital
- Investigators
- Qiang Zhao, MD, Study chair, Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, ChinaYunpeng Zhu, MD, Principal investigator, Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802926
- Sponsor's protocol ID
- KY-2025-777
- Acronym
- CoCAB-Pilot
- Status last verified
- Dec 2025
- First submitted
- 26 Jan 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes