Hs-CRP-Guided Colchicine Treatment Targets in Very-High-Risk Patients With Coronary Artery Disease After PCI (TARGET-CHD)

NCT07920133 · tracked via the Priya Life Science China tracker

Sponsor

Sir Run Run Shaw Hospital

Phase

Not applicable

Started

2026-12-01

Last updated

2026-11-05

Condition(s) studied

Coronary Artery DiseaseAtherosclerotic Cardiovascular Disease (ASCVD)Residual Inflammatory Risk

Investigational drug(s) / intervention(s)

Colchicine (Colcrys®) →Colchicine (Colcrys®) →

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

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

Study 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 (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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Age ≥18 years. 2. Diagnosed coronary artery disease and prior percutaneous coronary intervention. 3. 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. 4. Fasting LDL cholesterol ≤1.4 mmol/L measured within 1 month before enrollment. 5. 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. 6. Voluntary written informed consent. Exclusion Criteria: 1. Contraindication or allergy to colchicine, or colchicine use within the prior 4 weeks. 2. ALT or AST \>3 times the upper limit of normal, or eGFR \<30 mL/min/1.73 m². 3. Acute gout flare, serious infection requiring intravenous antibiotics, major surgery, or major trauma within the preceding 3 months. 4. Malignancy with expected survival \<18 months, autoimmune disease, ongoing immunosuppressive treatment, or chronic active infection such as active tuberculosis or hepatitis. 5. Critical illness, psychiatric illness or cognitive impairment affecting informed participation, or pregnancy, as specified among excluded vulnerable groups in the protocol. 6. Strong CYP3A4/P-glycoprotein inhibitor (e.g., clarithromycin, itraconazole, cyclosporine, verapamil) or moderate inhibitor (e.g., erythromycin, fluconazole) within 1 month before enrollment. 7. Concurrent participation in another interventional clinical study. 8. Any other reason the investigator considers the participant unsuitable.

Primary outcome measure(s)

Major Adverse Cardiovascular Events Through 18 Months — 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.

Trial sites (1)

Facility	City	Region	Status
Sir Run Run Shaw Hospital	Hangzhou	Zhejiang

More Sir Run Run Shaw Hospital trials in China

Comparison of the Safety and Aesthetic Outcomes of a Novel Endoscopic-Assisted Breast-Conserving Surgery (SRRSHzb-EABCS) With Those of Conventional Breast-Conserving Surgery Recruiting

Modified Short-Course Radiotherapy Combined With Immunochemotherapy and Targeted Therapy as First-Line Treatment for MSS Metastatic Colorectal Cancer Active, not recruiting

Smoking Cessation Program With CBT and Mindfulness Audio Support: A Randomized Controlled Trial Recruiting

Sirolimus-Coated Versus Paclitaxel-Coated Balloon for Recurrent Coronary In-Stent Restenosis After Prior Paclitaxel-Coated Balloon Treatment (SPRIT) Starting soon

The Treatment of Bioartificial Liver With hiHep Cells After Extensive Hepatectomy Recruiting

Other trials for the same condition

IVUS-guided DK Crush Stenting Technique for Patients With Complex Bifurcation Lesions Active, not recruiting

SGLT2 Inhibitors on Coronary Atherosclerosis Progression Via Perivascular Adipose Tissue in Diabetes Recruiting

Prospective Study Protocol for Multiparametric PCCT Assessment of Early Ventricular Outcomes After CABG Recruiting

Prognosis and Antiplatelet Strategies for Patients With PCI and High Bleeding Risk:A Study Protocol Recruiting

Sedentary Behavior Intervention for Older Adults With Coronary Heart Disease and Frailty Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07920133 on ClinicalTrials.gov ↗ ← All trials in China