Status:
UNKNOWN
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
Lead Sponsor:
Chinese Academy of Medical Sciences, Fuwai Hospital
Conditions:
Atherosclerotic Cardiovascular Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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.
Detailed Description
NXT-ASSESS is a placebo controlled,double-blind,randomised trial for assessment of the efficacy of Naoxingtong capsules in the treatment of coronary atherosclerotic plaque in patients with acute myoca...
Eligibility Criteria
Inclusion
- Signing informed consent;
- Male or female aged 18 to 75 years old;
- AMI patients with selective PCI indication primary PCI patients are exclusive;
- No history of CABG or PCI;
- Image inclusion criteria:
- 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);
- Radiography diameter of target vessel, 2.5-4.0mm;
- 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
- Life expectancy is less than 1 year;
- Cannot implant drug stent;
- Received ≥4weeks systematic treatment of statin and other lipid-lowering drug in the 3 months before admission;
- Received ≥4 weeks systematic treatment of any traditional Chinese medicine;
- Known to have adverse reaction to ingredients of NXT capsule;
- Patients with severe heart disease that CABG or selective PCI, heart transplantationSAVR/TAVR are required during the study(12 months);
- LVEF\<40%;
- 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;
- Known any stroke;
- Other operations arranged during the study period (12 months);
- Uncontrollable hypertension, defined as resting systolic BP≥180mmHg;
- Clinical confirmed as statin intolerance;
- Type I diabetes or type 2 diabetes that is not well controlled;
- Moderate and severe renal dysfunction (defined as eGFR\<30ml/min/1.73m2);
- Clinical confirmed liver disease or liver dysfunction (AST or ALT \>3\*ULN);
- Clinical confirmed infection and other hematological, metabolic gastrointestinal or endocrine dysfunction that researchers believe not suitable for enrollment;
- Known factors that may not be compliant, such as alcoholism, drug addiction, mental illness, etc.;
- Participated in other clinical research projects, or within 30 days of the last participating clinical project;
- Pregnant,breast feeding women or those plan to conceive during the study;
- History of malignant tumor.
- Lesion related:
- Target segment severe calcification;
- Failed PCI in culprit vessel;
- Failed OCT screening (lipid arc/ fiber cap thickness does not match filter criteria);
- Complications during the evaluation of OCT and IVUS/VH-IVUSOCT and IVUS/VH-IVUS evaluation failed due to instruments.
Key Trial Info
Start Date :
December 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05278182
Start Date
December 1 2022
End Date
June 30 2025
Last Update
May 20 2022
Active Locations (1)
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1
Chinese Academy of Medical Sciences, Fuwai Hospital
Beijing, Beijing Municipality, China, 100010