Using PCSK9 inhibitors to lower cholesterol in patients with high-risk coronary plaques

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 study evaluates the effectiveness of PCSK9 inhibitors in addition to standard lipid-modifying therapy compared to a placebo in patients with high-risk coronary plaques identified through CT angiography. The research focuses on patients who exhibit specific high-risk plaque features that are known to predict adverse cardiovascular events. By assessing clinical outcomes over a 24-month period, the study aims to determine if the addition of PCSK9 inhibitors can significantly reduce major adverse cardiac and cerebrovascular events. The study utilizes a randomized, controlled design to ensure robust results.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subject must be ≥ 18 years.
2. Patients with at least one target lesion meet CCTA-detected plaque features of the following:

   1. Degree of stenosis ≥ 50% or plaque burden ≥ 70%
   2. At least 2 of the following high-risk plaque features:

   i. Low-attenuation plaque ii. Positive remodeling iii. Napkin-ring sign iv. Spotty calcium
3. The target lesion is located at the proximal or mid segment of left anterior descending artery, left circumflex artery or right coronary artery.
4. Subject is able to confirm his/her understanding of the risks, benefits, and treatment alternatives of receiving study-related treatment. He/she or his/her legally authorized representative provides written informed consent prior to any study-related procedure.

Exclusion Criteria:

1. Target lesions underwent or planned to revascularization.
2. Patients with acute coronary syndrome.
3. New York Heart Association class III or IV, or last known left ventricular ejection fraction \< 30%.
4. Uncontrolled or recurrent ventricular tachycardia.
5. Homozygous familial hypercholesterolemia.
6. Active liver disease or hepatic dysfunction.
7. Failed CCTA plaque analysis.
8. Non-cardiac co-morbid conditions with life expectancy \< 2 years.
9. Pregnant and/or lactating women.
10. Known hypersensitivity or contraindication to statin or PCSK9 inhibitors.

Where it's running

• Zhejiang Provincial Hospital of Traditional Chinese Medicine
  Hangzhou, Zhejiang, China Recruiting
• Hangzhou Linping First People's Hospital
  Hangzhou, China Recruiting
• The Second Affiliated Hospital, School of Medicine, Zhejiang University
  Hangzhou, China Recruiting
• Zhejiang Hospital
  Hangzhou, China Recruiting
• Jinhua Central Hospital
  Jinhua, China Recruiting
• Seoul National University Hospital
  Seoul, South Korea Not yet recruiting

Study contacts

• Principal investigator: Xinyang Hu — Second Affiliated Hospital, Zhejiang University, School of Medicine
• Study coordinator: Xinyang Hu
• Email: hxy0507@126.com
• Phone: +86 0571 87784808

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• μFR-guided Drug-Coated Balloon Angioplasty vs Angiography-guided Angioplasty in Coronary Artery Disease

  This trial tests whether using computational μFR guidance during drug-coated balloon angioplasty is better than standard angiography guidance for people with de novo coronary artery lesions.

  Recruiting Centro Cardiologico Monzino · Cosenza, CS and 3 other locations · NCT07917234

• Gastric Ultrasound Before CABG to See if Heart Function Changes Stomach Contents

  This study checks whether people with weaker heart function before elective CABG have different stomach contents seen on ultrasound.

  Recruiting Adiyaman University · Adıyaman · NCT07898215

• Can preoperative photon-counting CT help predict heart recovery after bypass surgery?

  This observational study tests whether a preoperative photon-counting CT can help predict heart function 3 months after coronary bypass surgery in adults with coronary artery disease.

  Recruiting Chinese PLA General Hospital · Beijing · NCT07883499

• Real-World Drug-Coated Balloon Angioplasty in Coronary Artery Disease

  This registry tests how drug-coated balloons perform in everyday clinical practice for adults with coronary artery disease undergoing PCI.

  Recruiting at 5 sites Hospital Arnau de Vilanova · Mexico City, Mexico City and 4 other locations · NCT07875088

• Predicting vasopressor needs after anesthesia in elective on-pump CABG using dynamic arterial elastance

  This study tests whether EaDyn measured after induction can help predict which patients will need vasopressors during elective on-pump CABG.

  Recruiting University of Gaziantep · Gaziantep · NCT07871201

• Intraoperative Pulse Pressure Variation and Postoperative Lactate Clearance in CABG Patients

  This study tests whether the amount a patient’s pulse pressure varies during surgery relates to how quickly lactate levels drop after CABG.

  Recruiting University of Gaziantep · Gaziantep · NCT07871188

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.