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

NCT ID: NCT05278182

Last Updated: 2022-05-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-31
• Study Completion Date: 2025-06-30

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 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

Conditions

Atherosclerotic Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Naoxintong Capsule

Naoxintong Capsule

Group Type: EXPERIMENTAL

Naoxintong Capsule

Intervention Type: DRUG

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

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Naoxintong Capsule

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility 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;

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Runlin Gao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chinese Academy of Medical Sciences, Fuwai Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Qian Jie

Role: CONTACT

qianjfw@163.com

+86 13601396650

Runlin Gao, Prof

Role: CONTACT

gaorunlin@citmd.com

+86 13901207581

Facility Contacts

Qian Jie

Role: primary

qianjfw@163.com

+86 13601396650

Other Identifiers

CRFH20180010

Identifier Type: -

Identifier Source: org_study_id