Atherosclerotic Cardiovascular Disease
Conditions
Interventions
Arm 1:Naoxintong Capsule
Arm 2:Placebo
Sponsors
Buchang Pharmaceuticals
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion 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
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. LVEF3*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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Necrotic core;Fibrosis Composition;Fibrotic Lipid Composition;Calcification Composition;FCT; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total Atheroma Volume;Percent Atheroma Volume;Lipid Arc;Culprit in-Stent Intimal Thickness;LPAV;Plaque Burden;Calcification Volume;Fibrous Plaque Volume;Calcification Score;Total Cholesterol;LDL-C;HDL-C;Triglyceride;SdLDL;ApoA1;ApoB;ApoA1/ApoB;Lp-a;IL-6;IL-10;TNF-a;MMP-1;MMP-9;hsCRP;Platelet Functions;Platelet Counts;PT;APTT;TT;FIB;IMT;Largest Carotid Plaque Length;Largest carotid plaque thickness;Largest Carotid Plaque Nature;MACE; | — |
Countries
China
Contacts
Public ContactGao Runlin
FuWai Hospital Chinese Academy of Medical Sciences
Outcome results
None listed