Phase 4 Heart Disease Trial, Recruiting NCT06543082 Sponsor: CHA University Condition: Heart Disease
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Phase 4 Heart Disease Trial, Recruiting

NCT06543082
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have had a heart attack or acute coronary syndrome with a positive troponin blood test result, and who have had a specific type of heart stent placed (called an Orsiro stent, made by Biotronik AG).
  • People who have signed a written consent form agreeing to take part in the trial.

Who may not be able to join:

  • People who are under 19 years of age.
  • People whose previous stent has already failed due to re-narrowing or blockage inside the stent.
  • People who have experienced cardiac arrest or a state of severe heart failure called cardiogenic shock.
  • People who are currently taking or need to take certain medications that interact with a specific liver enzyme or drug transport system — including drugs such as ketoconazole, itraconazole, clarithromycin, ritonavir, cyclosporine, or ranolazine, among others (confirm with trial site for the full list).
  • People who have certain blood or digestive conditions, including low white blood cell or platelet counts, severe bowel disease, or rare genetic conditions such as galactose intolerance.
  • People who have had an allergic reaction to colchicine (a specific anti-inflammatory medication).
  • People who are already taking colchicine for another health condition.
  • People who need to take blood-thinning (anticoagulant) medication.
  • People with moderate or severe liver disease (classified by doctors as Child-Pugh class B or C).
  • People with significant kidney disease where the kidneys are filtering at a low rate (below 30 mL/min).
  • People who are pregnant, breastfeeding, or women who are of childbearing age.
  • People who currently have cancer or have been diagnosed with cancer within the past 5 years.
  • People whose life expectancy is less than 5 years.
  • People who cannot take a blood-thinning medication called ticagrelor — for example, due to a history of bleeding in the brain, active serious bleeding, or significant liver disease.
  • People who regularly take steroids, immunosuppressant medications, or biological therapies such as TNF-alpha inhibitors.
  • People who currently have an active infection.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 6 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Seung-Yul Lee, MD, CHA Bundang Medical Center

Phone: 82-31-780-5858

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
CHA University
Registry
ClinicalTrials.gov
Start date
5 August 2024
Est. completion
1 December 2028

Where this trial is recruiting

🇰🇷 South Korea

Primary endpoints

Efficacy Outcome: Net adverse clinical event; Safety Outcome: Stent thrombosis

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 6 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov