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

Study Overview
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Brief Summary
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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).

Detailed Description
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This study plans to enrol 1200 CCS patients. A central randomized control group will be set up. The experimental and control groups will be populated at a 3:1 ratio. In addition to basic medication, the experimental group will be given Yangxinshi tablets (three tablets each time, three times a day); the control group will be given basic medication only. The treatment period is 24 weeks. The primary efficacy indicator is the 6-minute walking distance (6MWD).

Official Title
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Yangxinshi Tablet Intervention for Exercise Capacity in Patients With Chronic Coronary Syndrome: Prospective, Multicentre, Randomized, Open-label, Blinded-endpoint Clinical Trial

Conditions
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Chronic Coronary Syndrome

Intervention / Treatment
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* Drug: Yangxinshi tablet
* Other: Basic medication


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18-75 years; 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; 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; voluntary participation and signing of informed consent. Exclusion Criteria: absolute or relative contraindications for the treadmill cardiopulmonary exercise test or 6-minute walk test (6MWT); serious primary diseases, mental diseases, or malignant tumours that affect lifespan; pregnancy, intended or suspected pregnancy, miscarriage, breastfeeding, or delivery in the last 6 months; 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>basic medication + Yangxinshi tablet | Drug: Yangxinshi tablet<br>* 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.<br>* Other names: Yangxinshi;|
| Other: Control group<br>basic medication. | Other: Basic medication<br>* The control group will be given basic medication only. The treatment period is 24 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6MWD | The 6-min walking distance | 24 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Borg scale | score range: 0 10,higher scores mean a worse outcome. | 24 weeks after treatment | 
| MACCE | incidence of major adverse cardiovascular and cerebrovascular events (MACCE) | after 4, 8, 12, 16, 20, and 24 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Yangxinshi, Chronic Coronary Syndrome