Coronary Artery Disease (CAD)Phase 4COLORNCT07349875
Colchicine Treatment for Non-Flow-Limiting Coronary Plaque by Coronary CTA: A Randomized Controlled Trial
A Phase 4 study testing Colchicine combined with Guideline-Directed Medical Therapy in people with Coronary Artery Disease (CAD), run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
This study is a prospective, multicenter, randomized controlled clinical trial designed to evaluate whether an anti-inflammatory medication can help improve heart health in patients with stable coronary artery disease. 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease (CAD)
- What is being tested?
- Colchicine combined with Guideline-Directed Medical Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,826 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 30 Jun 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- The subject (or legal guardian) understands the trial requirements and treatment procedure, and signs the written informed consent before undergoing any protocol-specified examinations or procedures;
- Aged ≥18 years;
- Clinically diagnosed with chronic coronary syndrome (CCS);
- CCTA confirms ≥50% stenosis in at least one epicardial coronary artery, and CT fractional flow reserve (CT-FFR) >0.80.
Who cannot join
- Unable or unwilling to provide informed consent;
- Unable to complete scheduled follow-up;
- Underwent PCI within the past 3 months;
- History of coronary artery bypass grafting (CABG);
- Diagnosis of acute coronary syndromes (ACS);
- No coronary plaque or plaque stenosis <50% (confirmed by CCTA);
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- Lesion-specific CT-FFR ≤0.80 in at least one major epicardial coronary artery;
- Inflammatory bowel disease (Crohn's disease/ulcerative colitis) or chronic diarrhea;
- History of gastric ulcer or gastric bleeding;
- Pregnant/lactating women or women of childbearing age without effective contraception;
- Neuromuscular disease or non-transient creatine kinase (CK) >3×upper limit of normal (ULN) (confirmed by ≥2 lab tests);
- Clinically significant non-transient hematological abnormalities (hemoglobin <100 g/L, hematocrit <30%/ >52%, white blood cell count <3×10⁹/L, platelet count <100×10⁹/L; confirmed by ≥2 lab tests);
- Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m² (CKD-EPI formula);
- Liver dysfunction (alanine aminotransferase >3×ULN and/or total bilirubin >2×ULN);
- Current/planned immunosuppressive therapy;
- Long-term colchicine use for other indications;
- Definite/suspected colchicine allergy;
- Active malignant tumor (expected survival <1 year);
- Use of potent CYP3A4/P-glycoprotein inhibitors (e.g., cyclosporine, antiretrovirals, antifungals, erythromycin, clarithromycin) without alternative drugs.
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
Nanjing First Hospital
Nanjing
Nanjing First Hospital, +86-25-52271350, jameszll@163.com
About this study
This study is a prospective, multicenter, randomized controlled clinical trial designed to evaluate whether an anti-inflammatory medication can help improve heart health in patients with stable coronary artery disease.
- Research Question \& Hypothesis We aim to determine whether adding low-dose colchicine (0.5 mg once daily) to standard medical treatment can further reduce the risk of major cardiovascular events in patients with chronic coronary syndromes (CCS), especially those with non-flow-limiting coronary plaques detected by coronary CT angiography (CCTA). We hypothesize that colchicine, by reducing vascular inflammation, may help prevent future heart attacks, strokes, and the need for coronary revascularization.
- Study Population \& Design Design: A rigorously designed, prospective, multicenter, randomized (1:1), controlled superiority trial. Population: Adults (>18 years) diagnosed with CCS, identified by CCTA as having at least one coronary artery with ≥50% narrowing but without significant impact on blood flow (CT-FFR > 0.80). Intervention: Intervention Group: Standard guideline-directed medical therapy (GDMT) + colchicine 0.5 mg once daily Control Group: GDMT alone Sample Size: Approximately 3,826 participants, accounting for a 5% dropout rate.
- Study Endpoints Primary Endpoint: The occurrence of major adverse cardiovascular or cerebrovascular events (MACCE), including:Cardiovascular death; Ischemic stroke; Non-fatal myocardial infarction; Any coronary revascularization. Assessed for 12 months after the last patient is enrolled.
Read more
Secondary Endpoints:Occurrence of MACCE over 36 months. Incidence and time to first occurrence of each event category at 12, 24, and 36 months.
Safety Endpoint: Side effects related to colchicine (e.g., gastrointestinal upset, liver or kidney abnormalities, blood disorders, muscle-related reactions).
- Conditions
- Coronary Artery Disease (CAD)
- Being tested
- Colchicine combined with Guideline-Directed Medical Therapy
- Keywords
- Chronic coronary syndromes, Coronary Artery Disease (CAD), Coronary Artery Disease, COLCHICINE, Vulnerable Plaque
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine combined with Guideline-Directed Medical TherapyDrug
colchicine combined with guideline-directed medical therapy group
| Study group | Role | What they receive |
|---|---|---|
| Guideline-Directed Medical Therapy Group | No intervention | Guideline-directed medical therapy (GDMT) alone Guideline-directed medical therapy is based on the Guidelines for the Diagnosis and Management of Patients with Chronic Coronary Syndromes in China and includes the following types of drug therapies: antiplatelet drugs (aspirin, indobufen, or clopidogrel); anticoagulant drugs (warfarin or new oral anticoagulants); lipid-lowering drugs (control target: LDL-C < 1.8 mmol/L with a reduction of ≥50% from baseline; for ultra-high-risk patients, LDL-C < 1.4 mmol/L with a reduction of ≥50% from baseline); drugs for relieving symptoms such as β-blockers, nitrates, and calcium channel blockers. The specific drug selection and treatment plan will be adjusted according to the clinician's judgment and the actual situation of the patient. |
| Colchicine plus Guideline-Directed Medical Therapy Group | Experimental | Guideline-directed medical therapy (GDMT) plus colchicine (0.5 mg once daily) Guideline-directed medical therapy is based on the Guidelines for the Diagnosis and Management of Patients with Chronic Coronary Syndromes in China and includes the following types of drug therapies: antiplatelet drugs (aspirin, indobufen, or clopidogrel); anticoagulant drugs (warfarin or new oral anticoagulants); lipid-lowering drugs (control target: LDL-C < 1.8 mmol/L with a reduction of ≥50% from baseline; for ultra-high-risk patients, LDL-C < 1.4 mmol/L with a reduction of ≥50% from baseline); drugs for relieving symptoms such as β-blockers, nitrates, and calcium channel blockers. The specific drug selection and treatment plan will be adjusted according to the clinician's judgment and the actual situation of the patient. Receives: Drug: Colchicine combined with Guideline-Directed Medical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular and cerebrovascular events (MACCE)
Composite of cardiovascular death, ischemic stroke, non-fatal myocardial infarction, and any coronary revascularization (follow-up ends when the last enrolled patient completes 12 months of follow-up).
Measured: 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Jan 2026
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease (CAD)Studies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe 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
- 3,826 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349875
- Sponsor's protocol ID
- KY20241217-10-KS-02
- Acronym
- COLOR
- Status last verified
- Jan 2026
- First submitted
- 29 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colchicine Treatment for Non-Flow-Limiting Coronary Plaque by Coronary CTA: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07349875
- Acronym / sponsor ID
- COLOR / KY20241217-10-KS-02
- Conditions
- Coronary Artery Disease (CAD)
- Keywords
- Chronic coronary syndromes, Coronary Artery Disease (CAD), Coronary Artery Disease, COLCHICINE, Vulnerable Plaque
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,826 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective, multicenter, randomized controlled clinical trial designed to evaluate whether an anti-inflammatory medication can help improve heart health in patients with stable coronary artery disease.
- Research Question \& Hypothesis We aim to determine whether adding low-dose colchicine (0.5 mg once daily) to standard medical treatment can further reduce the risk of major cardiovascular events in patients with chronic coronary syndromes (CCS), especially those with non-flow-limiting coronary plaques detected by coronary CT angiography (CCTA). We hypothesize that colchicine, by reducing vascular inflammation, may help prevent future heart attacks, strokes, and the need for coronary revascularization.
- Study Population \& Design Design: A rigorously designed, prospective, multicenter, randomized (1:1), controlled superiority trial. Population: Adults (>18 years) diagnosed with CCS, identified by CCTA as having at least one coronary artery with ≥50% narrowing but without significant impact on blood flow (CT-FFR > 0.80). Intervention: Intervention Group: Standard guideline-directed medical therapy (GDMT) + colchicine 0.5 mg once daily Control Group: GDMT alone Sample Size: Approximately 3,826 participants, accounting for a 5% dropout rate.
- Study Endpoints Primary Endpoint: The occurrence of major adverse cardiovascular or cerebrovascular events (MACCE), including:Cardiovascular death; Ischemic stroke; Non-fatal myocardial infarction; Any coronary revascularization. Assessed for 12 months after the last patient is enrolled.
Secondary Endpoints:Occurrence of MACCE over 36 months. Incidence and time to first occurrence of each event category at 12, 24, and 36 months.
Safety Endpoint: Side effects related to colchicine (e.g., gastrointestinal upset, liver or kidney abnormalities, blood disorders, muscle-related reactions).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guideline-Directed Medical Therapy Group | No intervention | –Guideline-directed medical therapy (GDMT) alone Guideline-directed medical therapy is based on the Guidelines for the Diagnosis and Management of Patients with Chronic Coronary Syndromes in China and includes the following types of drug therapies: antiplatelet drugs (aspirin, indobufen, or clopidogrel); anticoagulant drugs (warfarin or new oral anticoagulants); lipid-lowering drugs (control target: LDL-C < 1.8 mmol/L with a reduction of ≥50% from baseline; for ultra-high-risk patients, LDL-C < 1.4 mmol/L with a reduction of ≥50% from baseline); drugs for relieving symptoms such as β-blockers, nitrates, and calcium channel blockers. The specific drug selection and treatment plan will be adjusted according to the clinician's judgment and the actual situation of the patient. |
| Colchicine plus Guideline-Directed Medical Therapy Group | Experimental | Drug: Colchicine combined with Guideline-Directed Medical TherapyGuideline-directed medical therapy (GDMT) plus colchicine (0.5 mg once daily) Guideline-directed medical therapy is based on the Guidelines for the Diagnosis and Management of Patients with Chronic Coronary Syndromes in China and includes the following types of drug therapies: antiplatelet drugs (aspirin, indobufen, or clopidogrel); anticoagulant drugs (warfarin or new oral anticoagulants); lipid-lowering drugs (control target: LDL-C < 1.8 mmol/L with a reduction of ≥50% from baseline; for ultra-high-risk patients, LDL-C < 1.4 mmol/L with a reduction of ≥50% from baseline); drugs for relieving symptoms such as β-blockers, nitrates, and calcium channel blockers. The specific drug selection and treatment plan will be adjusted according to the clinician's judgment and the actual situation of the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The subject (or legal guardian) understands the trial requirements and treatment procedure, and signs the written informed consent before undergoing any protocol-specified examinations or procedures;
- Aged ≥18 years;
- Clinically diagnosed with chronic coronary syndrome (CCS);
- CCTA confirms ≥50% stenosis in at least one epicardial coronary artery, and CT fractional flow reserve (CT-FFR) >0.80.
Key exclusion criteria (19 listed)
- Unable or unwilling to provide informed consent;
- Unable to complete scheduled follow-up;
- Underwent PCI within the past 3 months;
- History of coronary artery bypass grafting (CABG);
- Diagnosis of acute coronary syndromes (ACS);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colchicine combined with Guideline-Directed Medical Therapycolchicine combined with guideline-directed medical therapy group | Drug | Colchicine plus Guideline-Directed Medical Therapy Group |
Primary outcome
Major adverse cardiovascular and cerebrovascular events (MACCE)
Time frame: 12 months after enrollment
Composite of cardiovascular death, ischemic stroke, non-fatal myocardial infarction, and any coronary revascularization (follow-up ends when the last enrolled patient completes 12 months of follow-up).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Colchicine combined with Guideline-Directed Medical Therapy in people with Coronary Artery Disease (CAD), run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun-Jie Zhang (+86-25-52271350, jameszll@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular and cerebrovascular events (MACCE) (time frame: 12 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.