Stable Coronary Artery Disease
Conditions
Interventions
Study group:Gelanxinning capsules +conventional treatment
Control group:Conventional treatment
Sponsors
the First Affiliated Hospital of Henan University of Chinese Medicine and Shanghai Changzheng Hospital
Eligibility
Sex/Gender
All
Age
35 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. 35 = age = 80 years. 2. meet the diagnostic criteria for SCAD/CCS according to the 2018 Chinese Guidelines for the Diagnosis and Treatment on the Stable Coronary Artery Disease or 2019 ESC guidelines for CCS [1] and have typical angina or angina equivalent symptoms including shortness of breath and fatigue. 3. Canadian Cardiovascular Society (CCS) class I to III and have =1 episode of angina or angina-equivalent symptom per week averagely within the previous 4 weeks. 4. have coronary artery imaging (coronary angiography or coronary CTA) within 1 year. 5. have objective evidence of myocardial ischaemia: (1) Dynamic ST-T changes demonstrated by electrocardiography/ambulatory electrocardiography monitoring at the onset of symptoms; (2) A previous history of definite myocardial infarction; (3) Previous coronary revascularization including percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG); (4) Myocardial iscaemia demonstrated by myocardial perfusion scintigraphy within 1 year; (5) Myocardial iscaemia demonstrated by stress electrocardiography or echocardiogram within 1 year. 6. currently using or need to use at least one kind of oral anti-anginal/ anti-iscaemic medication. 7. not used anti-anginal Traditional Chinese Medication in the previous 2 weeks. 8. understood the study and voluntarily signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) a history of myocardial infarction or revascularization within the previous 3 months or patients requiring revascularization after the current coronary angiography; (2) elevated troponin; (3) New York Heart Association (NYHA) class IV heart failure myocarditis hypertrophic obstructive cardiomyopathy or moderate-to-severe aortic valve disease; (4) patients with malignant tumours receiving or planning to receive treatment or requiring treatment; (5) history of severe hepatic or renal disease; (6) pregnant or lactating women; (7) suspected allergy to the study drug. (8) the investigator judges the individual unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| summary score of Seattle Angina Questionnaire (SAQ) at Week 12; | — |
Secondary
| Measure | Time frame |
|---|---|
| EQ-5D-5L score;number of ER visits due to chest pain;the frequency of angina attack in the prior 4 weeks at week 12;the proportion of patients with an improvement of at least one CCS class at Week 4 and Week 12;SAQ summary score at Week 4;score of each domain of SAQ at week 4 and week 12;nitroglycerin consumption;incidence of MACE;adverse events and serious adverse events; | — |
Countries
China
Contacts
Public Contactzhumingjun
The First Affiliated Hospital of Henan University of Chinese Medicine
Outcome results
None listed