Coronary heart disease (CHD) patients with chest pain after PCI
Conditions
Interventions
Experimental group:Standardized medical treatment + oral solution of Yinxing Mihuan
Control group:Standardized medical treatment + Placebo oral solution of Yinxing Mihuan
Sponsors
Fuwai Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Male or female aged 18-85 years; 2. Patients with a confirmed history of PCI of CHD more than 7 days and less than 365 days, and without need of selective coronary revascularization (PCI, CABG) plan judged by cardiovascular specialists; 3. Patients with symptoms related to heart, such as chest distress, chest pain, palpitation, shoulder and back pain, shortness of breath, weakness, activity intolerance. Angina attack frequency (AF) dimension score in the Seattle Angina Questionnaire (SAQ) is less than 80; 4. Hamilton Anxiety Scale score is 7-21 (mild to moderate anxiety); 5. Subjects are informed, and voluntarily sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant or preparing to be pregnant or nursing; menstruating woman; 2. Women of child-bearing age do not agree to use contraception on medication; 3. Patients with severe anxiety (Hamilton Anxiety Scale score greater than 21); 4. Patients with major depression (Hamilton depression scale score greater than or equal to 24); 5. Patients who are currently taking anti-anxiety medicines; 6. Stable angina of Grade 4 in Canadian cardiovascular association (CCS); 7. Uncontrolled hypertension (systolic > 180 mmhg or diastolic > 100 mmhg) despite ongoing antihypertensive treatment; 8. Grade III or IV heart failure in New York heart association (NYHA); 9. CHD patients with atrial fibrillation; 10. Clinically significant complications, including liver dysfunction (ALT or AST level is more than 2 times higher than normal), renal dysfunction (serum creatinine level is more than 2 times higher than normal), severe cardiopulmonary dysfunction, pulmonary hypertension, chronic obstructive pulmonary disease, history of cerebral hemorrhage or epilepsy, with need of anticonvulsant drugs; 11. Within 7 days of introduction period, patients who did not take medicine but with disappearance of related symptoms of CHD; 12. Three months before the start of the study, patients with myocardial infarction or grade IV angina; 13. Patients with acute coronary syndrome confirmed by examination and chest pain caused by rheumatic heart disease, cardiomegaly, severe neurosis, climacteric syndrome, hyperthyroidism, cervical spondylosis, choledochocardial syndrome, gastroesophageal reflux, hiatal hernia, aortic dissection, and so on; 14. History of specific bleeding or bleeding from warfarin; 15. Patients with previous hematopoietic diseases; 16. Patients who have undergone surgery within the last 4 weeks and are prone to bleeding (without PCI); 17. Patients who participate in any other clinical study or take any of its investigational medicine within 90 days; 18. Patients with known or suspected to be allergic to the medicine in this study or allergic constitution; 19. Drug abuser. Patient has a recent history (in the past 2 years) of alcohol abuse or a known history of drug dependence; 20. Psychopath; 21. Patients who have been judged by their doctors to be ineligible for the study; 22. Patients who are family members or relatives of the staff working in center.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SAQ Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| HAMA;HAMA score reduction rate;CCS and NYHA;VAS;HAMD;Frequency of angina - related symptoms per week;Nitroglycerin discontinuation and reduction rate;SF-12;Blood routine tests;Urine routine test;Stool routine test;Hepatic and renal function examination;Fasting blood glucose;blood lipids;Coagulation test;Troponin TnI;Thyroid function examination; | — |
Countries
China
Contacts
Public ContactYongjian Wu
Guangdong Hospital of Traditional Chinese Medicine
Outcome results
None listed