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

NCT05278182 | Unknown

• 1 other identifier: CRFH20180010
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerotic Cardiovascular Disease

Keywords

on the Basis of Optimal Medical Therapy

Outcome Measures

Primary Outcomes (2)

• Plaque composition

  The change of plaque composition by virtual histology intravascular ultrasound imaging in subjects who take Naoxintong capsules and placebo in post-percutaneous coronary intervention follow-up

  12 months

• Plaque fibrous cap thickness

  The change of plaque fibrous cap thickness measured by optical coherence tomography in subjects who take Naoxintong capsules and placebo during post-percutaneous coronary intervention follow-up

  12 months

Secondary Outcomes (7)

• Lipid arc

  12 months

• Percent atheroma volume

  12 months

• Total atheroma volume and low attenuation plaque volume

  12 months

• Lipid

  12 months

• Platelet function

  12 months

Study Arms (2)

Naoxintong Capsule

EXPERIMENTAL

Naoxintong Capsule

Drug: Naoxintong Capsule

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Naoxintong Capsule DRUG

Patients with acute myocardial infarct on the basis of optimal medical therapy will take Naoxintong capsules following directions for 12 months

Naoxintong Capsule

Placebo DRUG

Patients with acute myocardial infarct on the basis of optimal medical therapy will take placebo following directions for 12 months

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead

Study Sites (1)

Chinese Academy of Medical Sciences, Fuwai Hospital

Beijing, Beijing Municipality, 100010, China

Location

MeSH Terms

Conditions

Atherosclerosis

Interventions

naoxintong

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Qian Jie

CONTACT

+86 13601396650; qianjfw@163.com

Runlin Gao, Prof

CONTACT

+86 13901207581; gaorunlin@citmd.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 6, 2022
• First Posted: March 14, 2022
• Study Start: December 1, 2022
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: May 20, 2022

Record last verified: 2022-05

Locations

CN (1)