Yangxinshi Tablet Intervention for Exercise Capacity in Patients With Chronic Coronary Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Yangxinshi tablet, Basic medication.
- Who it may be relevant to
- Registry conditions: Chronic Coronary Syndrome. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Yangxinshi Tablet Intervention for Exercise Capacity in Patients With Chronic Coronary Syndrome: Prospective, Multicentre, Randomized, Open-label, Blinded-endpoint Clinical Trial
Overview
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
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).
Interventions
- Drug 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. - Other Basic medication
The control group will be given basic medication only. The treatment period is 24 weeks.
Primary outcome measures
- 6MWD [Time frame: 24 weeks after treatment]
Secondary outcome measures (2)
- Borg scale [Time frame: 24 weeks after treatment]
- MACCE [Time frame: after 4, 8, 12, 16, 20, and 24 weeks of treatment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 32 centers
- Shapingba District People's Hospital of Chongqing — Chongqing
- Zhengzhou Seventh People's Hospital — Zhengzhou
- Binzhou Medical University Hospital — Binzhou
- Binzhou People's Hospital — Binzhou
- Dezhou Municiple Hospital — Dezhou
- Pingyuan County first People's Hospital — Dezhou
- Feicheng People's Hospital — Feicheng
- Shandong Health Group Feicheng Hospital — Feicheng
- … and 24 more centers
Identifiers
NCT: NCT06171061 · GrowfulPower-008