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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShandong First Medical University

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Yangxinshi tablet
  • Basic medication

Treatment groups

1,200 Participants
are divided into 2 treatment groups