Phase 4 Heart Disease Trial, Recruiting NCT06338293 Sponsor: Nanjing First Hospital, Nanjing Medical University Condition: Heart Disease
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Phase 4 Heart Disease Trial, Recruiting

NCT06338293
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:

  • You are between 18 and 80 years old
  • A heart artery scan (coronary angiography) showed a partial blockage of 20–70% in a main heart artery, and further detailed imaging confirmed at least one unstable or "at-risk" fatty plaque in that artery, but the artery does not need a stenting procedure at this time (confirm with trial site)
  • You have been taking statin cholesterol-lowering medication for at least 4 weeks, but your LDL ("bad") cholesterol level is still 70 mg/dL or higher

Who may not be able to join:

  • You have had a heart attack in the last 30 days
  • The artery being studied has a very twisted or sharply angled blockage, a severe blockage in the main left heart artery, a completely blocked artery, or a blockage at a branching point
  • You have previously had open-heart bypass surgery (CABG)
  • Your blood triglyceride (fat) levels are very high — above 500 mg/dL
  • You have severe heart failure or serious breathing problems
  • You have severe kidney disease, active liver disease, or serious liver damage
  • You are allergic to statins or to the drug inclisiran, or you have previously used a type of cholesterol medication called a PCSK9 monoclonal antibody
  • You have a known active infection, or a serious blood, metabolism, or hormonal condition
  • You are planning to have non-heart-related surgery within the next 12 months
  • You are unable to attend follow-up appointments, or the researchers feel that your participation could put you at increased risk

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 2 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

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Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
Nanjing First Hospital, Nanjing Medical University
Registry
ClinicalTrials.gov
Start date
15 March 2024
Est. completion
30 June 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

The change rate of the thinnest fibrous cap of vulnerable plaque at the target vascular lesion from baseline to one-year follow-up(△ FCT%)

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: 2 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