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Clinical Trials in China / NCT06171061
Recruiting Phase 4

Yangxinshi Tablet Intervention for Exercise Capacity in Patients With Chronic Coronary Syndrome

NCT06171061 · tracked via the Priya Life Science China tracker
Sponsor
Shandong First Medical University
Phase
Phase 4
Started
2023-12-18
Last updated
2024-04-17

Condition(s) studied

Chronic Coronary Syndrome

Investigational drug(s) / intervention(s)

Yangxinshi tabletBasic medication

Yangxinshi tablet: In addition to basic medication, the experimental group will be given Yangxinshi (three tablets each time, three times a day);The treatment period is 24 weeks.

Basic medication: The control group will be given basic medication only. The treatment period is 24 weeks.

Study summary

This study is a prospective, multicentre, randomized, open-label, blinded-endpoint clinical trial to evaluate the efficacy and safety of Yangxinshi tablets in the treatment of patients with chronic coronary syndrome (CCS).

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. age 18-75 years; 2. CCS patients in stable condition and clearly diagnosed by coronary artery imaging (at least one vessel stenosis ≥ 50%): stable angina, ischaemic cardiomyopathy, asymptomatic or stable symptoms, occult coronary heart disease, acute coronary syndrome (ACS), or \>3 months after coronary revascularization; 3. moderately to severely limited exercise tolerance: the maximum 6MWD is \< 450 m, or the metabolic equivalent (MET) as measured by treadmill cardiopulmonary exercise testing is \< 5 METs; 4. voluntary participation and signing of informed consent. Exclusion Criteria: 1. absolute or relative contraindications for the treadmill cardiopulmonary exercise test or 6-minute walk test (6MWT); 2. serious primary diseases, mental diseases, or malignant tumours that affect lifespan; 3. pregnancy, intended or suspected pregnancy, miscarriage, breastfeeding, or delivery in the last 6 months; 4. subjects not suitable for this study in the opinion of the researchers, such as subjects who are participating in other drug clinical trials or intervention studies.

Primary outcome measure(s)

Trial sites (32)

FacilityCityRegionStatus
Shapingba District People's Hospital of Chongqing Chongqing Chongqing Municipality Not Yet Recruiting
Zhengzhou Seventh People's Hospital Zhengzhou Henan Not Yet Recruiting
Binzhou Medical University Hospital Binzhou Shandong Not Yet Recruiting
Binzhou People's Hospital Binzhou Shandong Not Yet Recruiting
Dezhou Municiple Hospital Dezhou Shandong Not Yet Recruiting
Pingyuan County first People's Hospital Dezhou Shandong Not Yet Recruiting
Feicheng People's Hospital Feicheng Shandong Recruiting
Shandong Health Group Feicheng Hospital Feicheng Shandong Recruiting
Affiliated Hospital of Shandong University of Traditional Chinese Medicine Jinan Shandong Recruiting
Jinan Central Hospital Jinan Shandong Not Yet Recruiting
Jinan Zhangqiu District People's Hospital Jinan Shandong Not Yet Recruiting
Shandong Provincial Hospital Affiliated to Shandong First Medical University Jinan Shandong Recruiting
The Fourth People's Hospital of Jinan Jinan Shandong Not Yet Recruiting
Gaotang County People's Hospital Liaocheng Shandong Not Yet Recruiting
Liaocheng Hospital of Traditional Chinese Medicine Liaocheng Shandong Not Yet Recruiting
Liaocheng People's Hospital Liaocheng Shandong Not Yet Recruiting
The Second People's Hospital of Liaocheng Liaocheng Shandong Not Yet Recruiting
Linqing City People's Hospital Linqing Shandong Not Yet Recruiting
Linyi People's Hospital Linyi Shandong Not Yet Recruiting
Longkou People Hosptial Longkou Shandong Not Yet Recruiting
Affiliated Hospital of Qingdao University Qingdao Shandong Recruiting
Hospital of Cardiovascular Diseases Affiliated to Qingdao University Qingdao Shandong Recruiting
Qingdao Central Hospital Qingdao Shandong Not Yet Recruiting
Qingdao Fuwai Hospital Qingdao Shandong Not Yet Recruiting
Qingdao Municipal Hospital Qingdao Shandong Not Yet Recruiting
Shandong University Qilu Hospital Qingdao District Qingdao Shandong Not Yet Recruiting
The Second Affiliated Hospital of Shandong First Medical University Taian Shandong Not Yet Recruiting
Xintai People's Hospital Taian Shandong Not Yet Recruiting
Tengzhou Central People's Hospital Tengzhou Shandong Not Yet Recruiting
Weifang City People's Hospital Weifang Shandong Not Yet Recruiting
Weifang City Yidu Central Hospital Weifang Shandong Not Yet Recruiting
Yantai Hospital of Traditional Chinese Medicine Yantai Shandong Not Yet Recruiting

More Shandong First Medical University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06171061 on ClinicalTrials.gov ↗ ← All trials in China