A Study for Exploring the Efficacy of Naoxintong Capsules in the Treatment of Coronary Atherosclerotic Plaque on the Basis of Optimal Medical Therapy (Aspirin,Statins,Clopidogrel, Etc.): Stage One

• Status: Not yet recruiting
• Trial end date: 2025-06-30
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate and compare the change of plaque composition by VH-IVUS imaging in subjects who take NXT and placebo in post-PCI of AMI patients during 12 months follow-up.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Criteria

Inclusion Criteria:

1. Signing informed consent;

2. Male or female aged 18 to 75 years old;

3. AMI patients with selective PCI indication primary PCI patients are exclusive;

4. No history of CABG or PCI;

Image inclusion criteria:

1. CCTA at least one in-segment ≥20% and ≤70% diameter stenosis non-culprit vessel in the proximal-middle segments of RCA, LCX, LAD (the proximal and distal plaque within 5mm, same as below);

2. Radiography diameter of target vessel, 2.5-4.0mm;

3. Studied vessel can be evaluated with OCT and IVUS; OCT: the visual target study lesion is lipid-rich plaque with lipid arc≥100 degree and fiber cap thickness≤120µm.

Exclusion Criteria:

1. Life expectancy is less than 1 year;

2. Cannot implant drug stent;

3. Received ≥4weeks systematic treatment of statin and other lipid-lowering drug in the 3 months before admission;

4. Received ≥4 weeks systematic treatment of any traditional Chinese medicine;

5. Known to have adverse reaction to ingredients of NXT capsule;

6. Patients with severe heart disease that CABG or selective PCI, heart transplantationSAVR/TAVR are required during the study(12 months);

7. LVEF<40%;

8. Drug uncontrollable recurrent and highly symptomatic arrhythmia such as ventricular tachycaidia, atrial fibrillation with rapid ventricular rate and paroxysmal supraventricular tachycardia in the 3 months before ACS admission;

9. Known any stroke;

10. Other operations arranged during the study period (12 months);

11. Uncontrollable hypertension, defined as resting systolic BP≥180mmHg;

12. Clinical confirmed as statin intolerance;

13. Type I diabetes or type 2 diabetes that is not well controlled;

14. Moderate and severe renal dysfunction (defined as eGFR<30ml/min/1.73m2);

15. Clinical confirmed liver disease or liver dysfunction (AST or ALT >3*ULN);

16. Clinical confirmed infection and other hematological, metabolic gastrointestinal or endocrine dysfunction that researchers believe not suitable for enrollment;

17. Known factors that may not be compliant, such as alcoholism, drug addiction, mental illness, etc.;

18. Participated in other clinical research projects, or within 30 days of the last participating clinical project;

19. Pregnant,breast feeding women or those plan to conceive during the study;

20. History of malignant tumor.

Lesion related:

1. Target segment severe calcification;

2. Failed PCI in culprit vessel;

3. Failed OCT screening (lipid arc/ fiber cap thickness does not match filter criteria);

4. Complications during the evaluation of OCT and IVUS/VH-IVUSOCT and IVUS/VH-IVUS evaluation failed due to instruments.