Evaluating colchicine therapy after heart procedures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness and safety of combining low-dose colchicine with ticagrelor P2Y12 inhibitor monotherapy in patients with acute coronary syndrome who have undergone percutaneous coronary intervention. The study aims to assess the frequency of serious cardiovascular events and stent thrombosis within 12 months post-intervention. Participants will be monitored for outcomes such as cardiovascular death, nonfatal myocardial infarction, and major bleeding. The trial builds on previous findings that suggested the feasibility of this treatment approach.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participants with positive troponin acute coronary syndrome who have undergone implantation of ultrathin bioresorbable polymer sirolimus-eluting stents (Orsiro; Biotronik AG).
* Participants who have provided written informed consent.

Exclusion Criteria:

* Under 19 years of age.
* Stent treatment failure lesions (stent restenosis or thrombosis).
* Cardiac arrest or cardiogenic shock.
* Currently taking or requiring strong CYP3A4 inhibitors (atazanavir, clarithromycin, darunavir/ritonavir, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, tipranavir/ritonavir) or P-glycoprotein inhibitors (cyclosporine, ranolazine).
* Presence of any of the following concomitant conditions: myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, aplastic anemia, severe gastrointestinal diseases, or genetic disorders such as galactose intolerance.
* Hypersensitivity to colchicine treatment.
* Currently taking colchicine for another condition.
* Requiring anticoagulant therapy.
* Liver disease classified as Child-Pugh class B or C.
* Renal disease with creatinine clearance \<30 mL/min.
* Pregnant, breastfeeding, or women of childbearing age.
* Currently has a malignancy or has a history of malignancy within the past 5 years.
* Life expectancy of less than 5 years.
* Contraindication for ticagrelor use (history of intracranial hemorrhage, active pathological bleeding, or liver disease classified as Child-Pugh class B or C).
* Patients receiving regular administration of systemic steroids, immunosuppressants, or biological agents (e.g., TNF-alpha inhibitors)
* Patients with active infectious diseases

Where it's running

• CHA Bundang Medical Center
  Seongnam-si, Gyeonggi-do, South Korea Recruiting
• Keimyung University Dongsan Hospital
  Daegu, South Korea Recruiting
• Wonkwang University Hospital
  Iksan, South Korea Recruiting
• Myongji Hospital
  Ilsan, South Korea Recruiting
• National Health Insurance Service Ilsan Hospital
  Ilsan, South Korea Recruiting
• Seoul National University Bundang Hospital
  Seongnam, South Korea Recruiting

Study contacts

• Principal investigator: Seung-Yul Lee, MD — CHA Bundang Medical Center
• Study coordinator: Hwa-In Kim
• Email: niawhz23@gmail.com
• Phone: 82-31-780-5858

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.