Chronic Coronary Syndrome
Conditions
Keywords
Yangxinshi, Chronic Coronary Syndrome
Brief summary
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
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.
OTHERBasic medication
The control group will be given basic medication only. The treatment period is 24 weeks.
Sponsors
Shandong First Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6MWD | 24 weeks after treatment | The 6-min walking distance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Borg scale | 24 weeks after treatment | score range: 0\ 10,higher scores mean a worse outcome. |
| MACCE | after 4, 8, 12, 16, 20, and 24 weeks of treatment | incidence of major adverse cardiovascular and cerebrovascular events (MACCE) |
Countries
China
Contacts
Primary ContactYuan Haitao
Outcome results
None listed