Recurrent angina pectoris after stent implantation in patients with multi-vessel coronary artery disease
Conditions
Interventions
control group:Guidelines recommend Western medicine drug therapy and placebo.
Experimental Group:The guidelines recommend Western medicine drug therapy and GuanXinSuHeWan
Sponsors
Second Hospital Affiliated to Harbin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 to 75 years old (inclusive), regardless of gender; 2. Patients diagnosed with coronary artery atherosclerotic heart disease - multi-vessel coronary artery disease by coronary angiography; 3. Patients meeting the diagnostic criteria for stable angina pectoris severity classification I to III in Western medicine; 4. Patients who have undergone PCI with DES implantation 1 to 3 years ago; 5. Patients with TCM syndrome differentiation belonging to cold coagulation in heart meridian; 6. Patients with angina pectoris attacks occurring at least 2 times per week and no more than 5 times per day; 7. Volunteers willing to participate in the trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients who require concurrent cardiovascular surgery, such as those with congenital heart disease (e.g., atrial septal defect, ventricular septal defect, endocardial cushion defect, Ebstein anomaly, tetralogy of Fallot, patent ductus arteriosus, aortopulmonary septal defect, ruptured sinus of Valsalva aneurysm), rheumatic heart valve disease, infective endocarditis, constrictive pericarditis or pericardial effusion, severe myocarditis or cardiomyopathy, or aortic dissection; 2. Patients with severe heart disease, such as: NYHA class III or IV heart function; left ventricular ejection fraction (LVEF) < 40%; severe arrhythmias (e.g., rapid atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, second-degree Mobitz type II or third-degree atrioventricular block); other severe heart diseases; or those who have had a pacemaker implanted within the past 3 months; 3. Cases of angina pectoris caused by other reasons, such as chest pain due to lesions other than coronary artery disease; severe neurosis, hyperthyroidism, biliary-cardiac syndrome, gastroesophageal reflux, etc.; 4. Patients with severe primary diseases of the liver, kidneys, hematopoietic system, etc. (e.g., ALT or AST more than 1.5 times the upper limit of normal; or estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m² (calculated according to the modified MDRD formula)); or patients with serious diseases affecting survival (e.g., tumors or AIDS); or patients with mental illness; 5. Patients with allergic constitution, or those known to be allergic to any drug components in the trial protocol; 6. Pregnant or lactating women, or those who cannot use effective contraception during the trial; 7. Patients who have participated in other clinical trials within the past 3 months; 8. Patients who have taken traditional Chinese medicine for angina pectoris (including decoctions, granules, and patent medicines) within 2 weeks before enrollment; 9. Patients currently using anticoagulants; 10. Patients who have undergone coronary artery bypass grafting; 11. Any other situations deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seattle Angina Questionnaire (SAQ) after 12 weeks of randomization; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of angina pectoris attacks per week;Duration of Angina Pectoris Pain;Classification of Angina Pectoris Severity;Evaluation of Efficacy in Symptoms of Angina Pectoris (Angina Pectoris Symptom Score: Number of Attacks, Duration, Degree of Pain);Incidence of major cardiovascular and cerebrovascular events (including any death, myocardial infarction, stroke, repeat revascularization, and hospitalization for angina);Efficacy Evaluation of TCM Syndrome (TCM Syndrome Efficacy Scoring);Echocardiogram;inflammatory markers (IL-6, CRP) ;NT-proBNP;cTnT/TnI ;Cardiopulmonary Exercise Test;Change in total distance of six-minute walk;Discontinuation and Reduction Rate of Nitrate Drugs; | — |
Countries
China
Contacts
Public ContactYu Bo
Second Affiliated Hospital of Harbin Medical University
Outcome results
None listed