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New treatment option for Coronary Artery Disease (CAD)
Official title Colchicine Treatment for Non-Flow-Limiting Coronary Plaque by Coronary CTA: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT07349875
What this study is testing
What is Colchicine combined with Guideline-Directed Medical Therapy?
Colchicine combined with Guideline-Directed Medical Therapy is an investigational medicine, given as an once-daily, being studied as a potential treatment for coronary artery disease (cad).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Time commitment: about 36 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The subject (or legal guardian) understands the trial requirements and treatment procedure, and signs the written informed consent before undergoing...
- 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.
You likely can't join if
- 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);
See the full eligibility criteria
- 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.
- 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);
- 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 \ 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.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 36 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.