Coronary Artery DiseaseNCT07920133
Hs-CRP-Guided Colchicine Treatment Targets in Very-High-Risk Patients With Coronary Artery Disease After PCI (TARGET-CHD)
A study testing Colchicine (Colcrys®) in people with Coronary Artery Disease and Atherosclerotic Cardiovascular Disease (ASCVD), run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
This multicenter, randomized, open-label, noninferiority trial will compare two high-sensitivity C-reactive protein (hs-CRP) target-guided colchicine strategies in 1,768 adults with very-high-risk coronary artery disease after percutaneous coronary intervention, LDL cholesterol ≤1.4 mmol/L, and residual inflammation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Atherosclerotic Cardiovascular Disease (ASCVD), Residual Inflammatory Risk
- What is being tested?
- Colchicine (Colcrys®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,768 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2026to 31 Dec 2032
- Phase
- Interventional
- 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
- Age ≥18 years.
- Diagnosed coronary artery disease and prior percutaneous coronary intervention.
- Very-high-risk atherosclerotic cardiovascular disease, defined as at least two major ASCVD events or one major ASCVD event plus at least two high-risk conditions according to the 2023 Chinese lipid management guideline.
- Fasting LDL cholesterol ≤1.4 mmol/L measured within 1 month before enrollment.
- Fasting hs-CRP 2.0-10.0 mg/L measured within 7 days before enrollment, without a recent infection, surgery, trauma, or other acute inflammatory condition.
- Voluntary written informed consent.
Who cannot join
- Contraindication or allergy to colchicine, or colchicine use within the prior 4 weeks.
- ALT or AST >3 times the upper limit of normal, or eGFR <30 mL/min/1.73 m².
- Acute gout flare, serious infection requiring intravenous antibiotics, major surgery, or major trauma within the preceding 3 months.
- Malignancy with expected survival <18 months, autoimmune disease, ongoing immunosuppressive treatment, or chronic active infection such as active tuberculosis or hepatitis.
- Critical illness, psychiatric illness or cognitive impairment affecting informed participation, or pregnancy, as specified among excluded vulnerable groups in the protocol.
- Strong CYP3A4/P-glycoprotein inhibitor (e.g., clarithromycin, itraconazole, cyclosporine, verapamil) or moderate inhibitor (e.g., erythromycin, fluconazole) within 1 month before enrollment.
- Concurrent participation in another interventional clinical study.
- Any other reason the investigator considers the participant unsuitable.
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
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang
Wenbin Zhang, Dr., 0571-86006241, wzhang_crf@126.com
Wenbin Zhang, Dr.
About this study
Official title: Colchicine Titration Guided by Hs-CRP Targets on Cardiovascular Events in Very-High-Risk Coronary Heart Disease Patients After PCI: A Multicenter, Randomized, Open-Label, Noninferiority Trial
This multicenter, randomized, open-label, noninferiority trial will compare two high-sensitivity C-reactive protein (hs-CRP) target-guided colchicine strategies in 1,768 adults with very-high-risk coronary artery disease after percutaneous coronary intervention, LDL cholesterol ≤1.4 mmol/L, and residual inflammation (hs-CRP 2.0-10.0 mg/L). Participants will be assigned 1:1 to a standard target of 1.0 to <2.0 mg/L or an intensive target of <1.0 mg/L. Both groups will start colchicine 0.25 mg orally once daily, with dose adjustments guided by hs-CRP and tolerability. The primary outcome is the 18-month composite of cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, or ischemia-driven revascularization. The noninferiority hypothesis compares the standard target strategy with the intensive target strategy, with a prespecified hazard-ratio margin of 1.30.
Read the detailed description
Adults with coronary artery disease after PCI who meet very-high-risk atherosclerotic cardiovascular disease criteria, have fasting LDL cholesterol ≤1.4 mmol/L within 1 month, and have fasting hs-CRP 2.0-10.0 mg/L within 7 days before enrollment will be randomized through a central system. Randomization is stratified by center, baseline hs-CRP (<5 vs ≥5 mg/L), and age (<65 vs ≥65 years). All participants continue standard coronary disease care and start colchicine 0.25 mg orally daily. At 1 month, the intensive group maintains the dose when hs-CRP is <1.0 mg/L or, if tolerated, increases to 0.5 mg daily otherwise. The standard group reduces to 0.25 mg every other day if hs-CRP is <1.0 mg/L, continues 0.25 mg daily if hs-CRP is 1.0 to <2.0 mg/L, or, if tolerated, increases to 0.5 mg daily if hs-CRP is ≥2.0 mg/L. Participants who increase to 0.5 mg daily undergo repeat assessment after another month. If the assigned target remains unmet after one month at 0.5 mg daily, protocol-directed colchicine is stopped while clinical and safety follow-up continues under the original randomized assignment. Doses may be reduced or treatment stopped for adverse reactions; interruptions may occur during acute infection or elective surgery. Follow-up assessments occur at 1, 3, 6, 12, and 18 months, with an additional 2-month assessment for participants whose dose was increased at 1 month. An independent blinded clinical events committee adjudicates events.
- Conditions
- Coronary Artery Disease, Atherosclerotic Cardiovascular Disease (ASCVD), Residual Inflammatory Risk
- Being tested
- Colchicine (Colcrys®)
- Keywords
- colchicine; high-sensitivity C-reactive protein; hs-CRP; treat to target; secondary prevention; percutaneous coronary intervention; noninferiority; TARGET-CHD
- Medical subject headings
- Coronary Artery Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine (Colcrys®)Drug
Oral colchicine 0.25 mg daily initially, titrated or reduced according to hs-CRP target 1.0 to <2.0 mg/L and tolerability, with a maximum of 0.5 mg daily
Colchicine (Colcrys®)Drug
Oral colchicine 0.25 mg daily initially, titrated according to hs-CRP target <1.0 mg/L and tolerability, with a maximum of 0.5 mg daily
| Study group | Role | What they receive |
|---|---|---|
| Standard hs-CRP Target (1.0 to <2.0 mg/L) | Experimental | Colchicine 0.25 mg orally once daily at initiation, with hs-CRP-guided adjustments to target 1.0 to <2.0 mg/L. At 1 month, reduce to 0.25 mg every other day if hs-CRP <1.0 mg/L; maintain 0.25 mg daily if 1.0 to <2.0 mg/L; or, if tolerated, increase to 0.5 mg daily if ≥2.0 mg/L. If the target remains unmet after one month at 0.5 mg daily, stop protocol-directed colchicine and continue endpoint/safety follow-up. Dose reduction or discontinuation is permitted for adverse reactions. Receives: Drug: Colchicine (Colcrys®) |
| Intensive hs-CRP Target (<1.0 mg/L) | Active comparator | Colchicine 0.25 mg orally once daily at initiation, with hs-CRP-guided adjustments to target <1.0 mg/L. At 1 month, maintain 0.25 mg daily if hs-CRP <1.0 mg/L; otherwise, if tolerated, increase to 0.5 mg daily. If the target remains unmet after one month at 0.5 mg daily, stop protocol-directed colchicine and continue endpoint/safety follow-up. Dose reduction or discontinuation is permitted for adverse reactions. Receives: Drug: Colchicine (Colcrys®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events Through 18 Months
Time to first occurrence of cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, or ischemia-driven coronary revascularization. The primary noninferiority comparison is the hazard ratio for the standard hs-CRP target strategy versus the intensive hs-CRP target strategy, with a prespecified margin of 1.30; events are adjudicated by an independent blinded clinical events committee.
Measured: From randomization through 18 months
Secondary outcomes (12)
Key Safety Composite Event Through 18 Months
Time to first occurrence of CTCAE grade ≥3 gastrointestinal adverse reaction, symptomatic creatine kinase elevation or rhabdomyolysis, ≥30% decline in estimated glomerular filtration rate, or drug-related serious adverse event. A superiority comparison of the two randomized strategies is prespecified; the direction and multiplicity sequence must match the final protocol
Measured: From randomization through 18 months
Cardiovascular Death Through 18 Months
Time to cardiovascular death, as adjudicated by the blinded clinical events committee.
Time Frame: From randomization through 18 months
Measured: From randomization through 18 months
Nonfatal Myocardial Infarction Through 18 Months
Time to nonfatal myocardial infarction as defined in the protocol and adjudicated by the blinded clinical events committee.
Measured: From randomization through 18 months
Nonfatal Ischemic Stroke Through 18 Months
Time to nonfatal ischemic stroke as defined in the protocol and adjudicated by the blinded clinical events committee.
Measured: From randomization through 18 months
Ischemia-Driven Revascularization Through 18 Months
Time to PCI or coronary bypass surgery performed because of ischemic symptoms or objective evidence of myocardial ischemia
Measured: From randomization through 18 months
Change in hs-CRP From Baseline
Change in fasting hs-CRP concentration from baseline, expressed in mg/L, at each scheduled follow-up assessment.
Measured: Baseline and 3, 6, 12, and 18 months
Proportion With hs-CRP <1.0 mg/L
Proportion of evaluated participants with fasting hs-CRP <1.0 mg/L at each scheduled assessment.
Measured: 3, 6, 12, and 18 months
Proportion With hs-CRP <2.0 mg/L
Proportion of evaluated participants with fasting hs-CRP <2.0 mg/L at each scheduled assessment.
Measured: 3, 6, 12, and 18 months
Average Daily Colchicine Dose
Average administered daily colchicine dose in milligrams over the treatment period; exact denominator and handling of interruptions to be specified in the statistical analysis plan.
Measured: From randomization through 18 months
Colchicine Dose Reduction
Proportion of participants with at least one protocol-directed reduction in colchicine dose.
Measured: From randomization through 18 months
Colchicine Discontinuation
Proportion of participants who permanently discontinue protocol-directed colchicine, with reasons recorded
Measured: From randomization through 18 months
Cumulative Colchicine Exposure Duration
Total number of days taking colchicine during study follow-up; interruptions and discontinuations are recorded.
Measured: From randomization through 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,768 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenbin Zhang, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07920133
- Sponsor's protocol ID
- TARGET-CHD
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 5 Nov 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 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colchicine Titration Guided by Hs-CRP Targets on Cardiovascular Events in Very-High-Risk Coronary Heart Disease Patients After PCI: A Multicenter, Randomized, Open-Label, Noninferiority Trial
- ClinicalTrials.gov ID
- NCT07920133
- Acronym / sponsor ID
- TARGET-CHD
- Conditions
- Coronary Artery Disease, Atherosclerotic Cardiovascular Disease (ASCVD), Residual Inflammatory Risk
- Keywords
- colchicine; high-sensitivity C-reactive protein; hs-CRP; treat to target; secondary prevention; percutaneous coronary intervention; noninferiority; TARGET-CHD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,768 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 5 Nov 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 multicenter, randomized, open-label, noninferiority trial will compare two high-sensitivity C-reactive protein (hs-CRP) target-guided colchicine strategies in 1,768 adults with very-high-risk coronary artery disease after percutaneous coronary intervention, LDL cholesterol ≤1.4 mmol/L, and residual inflammation (hs-CRP 2.0-10.0 mg/L). Participants will be assigned 1:1 to a standard target of 1.0 to <2.0 mg/L or an intensive target of <1.0 mg/L. Both groups will start colchicine 0.25 mg orally once daily, with dose adjustments guided by hs-CRP and tolerability. The primary outcome is the 18-month composite of cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, or ischemia-driven revascularization. The noninferiority hypothesis compares the standard target strategy with the intensive target strategy, with a prespecified hazard-ratio margin of 1.30.
Detailed description
Adults with coronary artery disease after PCI who meet very-high-risk atherosclerotic cardiovascular disease criteria, have fasting LDL cholesterol ≤1.4 mmol/L within 1 month, and have fasting hs-CRP 2.0-10.0 mg/L within 7 days before enrollment will be randomized through a central system. Randomization is stratified by center, baseline hs-CRP (<5 vs ≥5 mg/L), and age (<65 vs ≥65 years). All participants continue standard coronary disease care and start colchicine 0.25 mg orally daily. At 1 month, the intensive group maintains the dose when hs-CRP is <1.0 mg/L or, if tolerated, increases to 0.5 mg daily otherwise. The standard group reduces to 0.25 mg every other day if hs-CRP is <1.0 mg/L, continues 0.25 mg daily if hs-CRP is 1.0 to <2.0 mg/L, or, if tolerated, increases to 0.5 mg daily if hs-CRP is ≥2.0 mg/L. Participants who increase to 0.5 mg daily undergo repeat assessment after another month. If the assigned target remains unmet after one month at 0.5 mg daily, protocol-directed colchicine is stopped while clinical and safety follow-up continues under the original randomized assignment. Doses may be reduced or treatment stopped for adverse reactions; interruptions may occur during acute infection or elective surgery. Follow-up assessments occur at 1, 3, 6, 12, and 18 months, with an additional 2-month assessment for participants whose dose was increased at 1 month. An independent blinded clinical events committee adjudicates events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard hs-CRP Target (1.0 to <2.0 mg/L) | Experimental | Drug: Colchicine (Colcrys®)Colchicine 0.25 mg orally once daily at initiation, with hs-CRP-guided adjustments to target 1.0 to <2.0 mg/L. At 1 month, reduce to 0.25 mg every other day if hs-CRP <1.0 mg/L; maintain 0.25 mg daily if 1.0 to <2.0 mg/L; or, if tolerated, increase to 0.5 mg daily if ≥2.0 mg/L. If the target remains unmet after one month at 0.5 mg daily, stop protocol-directed colchicine and continue endpoint/safety follow-up. Dose reduction or discontinuation is permitted for adverse reactions. |
| Intensive hs-CRP Target (<1.0 mg/L) | Active comparator | Drug: Colchicine (Colcrys®)Colchicine 0.25 mg orally once daily at initiation, with hs-CRP-guided adjustments to target <1.0 mg/L. At 1 month, maintain 0.25 mg daily if hs-CRP <1.0 mg/L; otherwise, if tolerated, increase to 0.5 mg daily. If the target remains unmet after one month at 0.5 mg daily, stop protocol-directed colchicine and continue endpoint/safety follow-up. Dose reduction or discontinuation is permitted for adverse reactions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years.
- Diagnosed coronary artery disease and prior percutaneous coronary intervention.
- Very-high-risk atherosclerotic cardiovascular disease, defined as at least two major ASCVD events or one major ASCVD event plus at least two high-risk conditions according to the 2023 Chinese lipid management guideline.
- Fasting LDL cholesterol ≤1.4 mmol/L measured within 1 month before enrollment.
- Fasting hs-CRP 2.0-10.0 mg/L measured within 7 days before enrollment, without a recent infection, surgery, trauma, or other acute inflammatory condition.
Key exclusion criteria (8 listed)
- Contraindication or allergy to colchicine, or colchicine use within the prior 4 weeks.
- ALT or AST >3 times the upper limit of normal, or eGFR <30 mL/min/1.73 m².
- Acute gout flare, serious infection requiring intravenous antibiotics, major surgery, or major trauma within the preceding 3 months.
- Malignancy with expected survival <18 months, autoimmune disease, ongoing immunosuppressive treatment, or chronic active infection such as active tuberculosis or hepatitis.
- Critical illness, psychiatric illness or cognitive impairment affecting informed participation, or pregnancy, as specified among excluded vulnerable groups in the protocol.
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 (Colcrys®)Oral colchicine 0.25 mg daily initially, titrated or reduced according to hs-CRP target 1.0 to <2.0 mg/L and tolerability, with a maximum of 0.5 mg daily | Drug | Standard hs-CRP Target (1.0 to <2.0 mg/L) |
| Colchicine (Colcrys®)Oral colchicine 0.25 mg daily initially, titrated according to hs-CRP target <1.0 mg/L and tolerability, with a maximum of 0.5 mg daily | Drug | Intensive hs-CRP Target (<1.0 mg/L) |
Primary outcome
Major Adverse Cardiovascular Events Through 18 Months
Time frame: From randomization through 18 months
Time to first occurrence of cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, or ischemia-driven coronary revascularization. The primary noninferiority comparison is the hazard ratio for the standard hs-CRP target strategy versus the intensive hs-CRP target strategy, with a prespecified margin of 1.30; events are adjudicated by an independent blinded clinical events committee.
12 secondary outcomes
Key Safety Composite Event Through 18 Months
Time frame: From randomization through 18 months
Cardiovascular Death Through 18 Months
Time frame: From randomization through 18 months
Nonfatal Myocardial Infarction Through 18 Months
Time frame: From randomization through 18 months
Nonfatal Ischemic Stroke Through 18 Months
Time frame: From randomization through 18 months
Ischemia-Driven Revascularization Through 18 Months
Time frame: From randomization through 18 months
Change in hs-CRP From Baseline
Time frame: Baseline and 3, 6, 12, and 18 months
Proportion With hs-CRP <1.0 mg/L
Time frame: 3, 6, 12, and 18 months
Proportion With hs-CRP <2.0 mg/L
Time frame: 3, 6, 12, and 18 months
Average Daily Colchicine Dose
Time frame: From randomization through 18 months
Colchicine Dose Reduction
Time frame: From randomization through 18 months
Colchicine Discontinuation
Time frame: From randomization through 18 months
Cumulative Colchicine Exposure Duration
Time frame: From randomization through 18 months
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 5 Nov 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 study testing Colchicine (Colcrys®) in people with Coronary Artery Disease and Atherosclerotic Cardiovascular Disease (ASCVD), run by Sir Run Run Shaw Hospital 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 6 inclusion and 8 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: opening soon, as of the sponsor's last update on 5 Nov 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.
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 Wenbin Zhang, Dr. (0571-86006241, wzhang_crf@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular Events Through 18 Months (time frame: From randomization through 18 months). 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 5 Nov 2026.