chronic coronary syndrome
Conditions
Interventions
control group:Standardized treatment in Western medicine
test group:Standardized treatment of Fuchan granules in combination with Western medicine
Sponsors
Affiliated Hospital to Changchun University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Patients with a diagnosis of chronic coronary syndrome and coronary CTA or coronary angiography results suggesting 50-80% coronary lumen stenosis within one year; (2) Patients with a CCS angina classification of I to III who have received fixed-dose optimal drug therapy for at least 2 weeks and who are intolerant hyporesponsive or resistant to nitrates; (3) Patients with prior ACS with or without PCI requiring dual-antibody medication for more than 36 months and patients at low/moderate risk of bleeding and ischemia after PCI requiring dual-antibody therapy for more than 6 months with only single-agent antiplate therapy currently applied; (4) Those who meet the Chinese medicine identification criteria of qi and yang deficiency and qi stagnation; (5) Patients aged 18 to 75 years old gender is not limited; (6) Voluntarily participate in the trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Excluding patients with heart failure heart valve disease chronic kidney disease or other severe combined heart lung liver and vital organ dysfunction; (2) Patients with combined malignant tumors and hematologic diseases; (3) Patients with suspected vasospasm or microvascular disease excluding angina pectoris; (4) Patients with high bleeding risk and/or high ischemic risk assessed according to the 2024 Chinese Guidelines for the Diagnosis and Management of Patients with Chronic Coronary Syndrome; (5) Patients with poor control of lipids blood glucose and blood pressure; (6) Patients with recent active bleeding; (7) Patients involved in other clinical drug trials; (8) Allergic or allergic to multiple drugs and foods or known allergy to the components of the drug severe psychiatric and psychological disorders pregnant and lactating women; (9) Persons who in the judgment of the investigator are not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with improvement in total Seattle Angina Questionnaire score of 20 points or more; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in TCM evidence scores ;Change from baseline in Seattle Scale scores for each domain at 30 60 and 90 days;Incidence of major adverse cardiovascular events;Change from baseline in angina points ;Discontinuation rate of Suxiao jiuxin pills pills;ECG efficacy; | — |
Countries
China
Contacts
Public ContactJiajuan Guo
Affiliated Hospital to Changchun University of Chinese Medicine
Outcome results
None listed