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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Yangxinshi tablet

    Drug

    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

    Other intervention

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

Treatment groups

1,200 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 1 intervention
Group B: Control groupOther 1 intervention

Trial outcomes

Primary outcomes

1

6MWD

The 6-min walking distance

Time frame
24 weeks after treatment

Secondary outcomes

1

Borg scale

score range: 0\~10,higher scores mean a worse outcome.

Time frame
24 weeks after treatment
2

MACCE

incidence of major adverse cardiovascular and cerebrovascular events (MACCE)

Time frame
after 4, 8, 12, 16, 20, and 24 weeks of treatment

Other outcomes

Sponsors and contacts

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