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 (NXT-ASSESS)

A Placebo Controlled, Double-blind, Randomised Trial for Assessment of the Efficacy of Naoxintong Capsules in the Treatment of Coronary Atherosclerotic Plaque in Patients With Acute Myocardial Infarct on the Basis of Optimal Medical Therapy (Aspirin,Statins, Clopidogrel, Etc.)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atherosclerotic Cardiovascular Disease
• Intervention / Treatment: Drug: Naoxintong Capsule; Drug: Placebo

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 myocardial infarct on the basis of optimal medical therapy.A total of approximately 80 AMI patients with selective PCI indication who take NXT and placebo in post-PCI 12 months

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qian Jie; Phone Number: +86 13601396650; Email: qianjfw@163.com
• Study Contact Backup: Name: Runlin Gao, Prof; Phone Number: +86 13901207581; Email: gaorunlin@citmd.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100010
      • Chinese Academy of Medical Sciences, Fuwai Hospital
      • Contact: Qian Jie; Phone Number: +86 13601396650; Email: qianjfw@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Patients with acute myocardial infarct on the basis of optimal medical therapy will take placebo following directions for 12 months
Experimental: Naoxintong Capsule	Drug: Naoxintong Capsule; Patients with acute myocardial infarct on the basis of optimal medical therapy will take Naoxintong capsules following directions for 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lipid arc	The change of lipid arc measured by optical coherence tomography in subjects who take Naoxintong capsules and placebo in post-percutaneous coronary intervention follow-up	12 months
Percent atheroma volume	The change of percent atheroma volume measured by intravascular ultrasound imaging in subjects who take Naoxintong capsules and placebo capsules during post-percutaneous coronary intervention follow-up	12 months
Total atheroma volume and low attenuation plaque volume	Total atheroma volume and low attenuation plaque volume measured by Coronary-CTA in subjects who take Naoxintong and placebo capsules during post-percutaneous coronary intervention follow-up	12 months
Lipid	The change of lipid measured by optical coherence tomography in subjects who take Naoxintong capsules	12 months
Platelet function	The change of platelet function measured by optical coherence tomography in subjects who take Naoxintong capsules	12 months
Clinical incidents	The number of clinical incidents in subjects who take Naoxintong capsules	12 months
Culprit vessel	The change of subjects culprit vessel with optical coherence tomography;	12 months

Collaborators and Investigators

• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): June 30, 2025
• Study Completion (Anticipated): June 30, 2025

Study Registration Dates

• First Submitted: February 6, 2022
• First Submitted That Met QC Criteria: March 3, 2022
• First Posted (Actual): March 14, 2022

Study Record Updates

• Last Update Posted (Actual): May 20, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: on the Basis of Optimal Medical Therapy
• Additional Relevant MeSH Terms: Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Cardiovascular Diseases; Atherosclerosis; Plaque, Atherosclerotic
• Other Study ID Numbers: CRFH20180010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No