Yangxinshi tablets for improving exercise capacity in chronic coronary syndrome patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of Yangxinshi tablets in patients with chronic coronary syndrome (CCS). It is a multicenter, randomized, open-label trial involving 1200 participants, where patients will be assigned to either an experimental group receiving Yangxinshi tablets alongside basic medication or a control group receiving only basic medication. The treatment duration is 24 weeks, and the primary outcome measure is the 6-minute walking distance (6MWD). The study aims to determine if the addition of Yangxinshi tablets can enhance exercise capacity in CCS patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• Feicheng People's Hospital
  Feicheng, Shandong, China Recruiting
• Shandong Health Group Feicheng Hospital
  Feicheng, Shandong, China Recruiting
• Affiliated Hospital of Shandong University of Traditional Chinese Medicine
  Jinan, Shandong, China Recruiting
• Shandong Provincial Hospital Affiliated to Shandong First Medical University
  Jinan, Shandong, China Recruiting
• Affiliated Hospital of Qingdao University
  Qingdao, Shandong, China Recruiting
• Hospital of Cardiovascular Diseases Affiliated to Qingdao University
  Qingdao, Shandong, China Recruiting

Study contacts

• Principal investigator: Yuan Haitao — Shandong Provincial Hospital
• Study coordinator: Yuan Haitao
• Email: doctoryuanht@126.com
• Phone: 0531-68776356

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.