Yinxingmihuan Oral Solution in Treatment of Chest Pain After PCI

Prior treatment

• patients who are currently taking anti-anxiety drug;
• within the three months before start of the study, patients with myocardial infarction or CCS 4 angina;
• patients with previous hematopoietic diseases;
• patients who participate in any other clinical study or take any other investigational drug within 90 days;

Other illness

• participants with stable angina classified into Canadian Cardiovascular Society (CCS) Grade 4;
• uncontrolled hypertension (systolic \> 180 mmHg or diastolic \> 100 mmHg) despite using ongoing antihypertensive treatment;
• heart failure assessed by New York Heart Association (NYHA);
• patients with coronary heart disease and atrial fibrillation;
• within 7 days of introduction period, patients who no longer have angina-related symptoms;
• patients with acute coronary syndrome confirmed by examinations and other chest pain caused by rheumatic heart disease, dilated cardiomyopathy, severe neurosis, menopausal syndrome, hyperthyroidism, cervical spondylosis, bilio-cardiac syndrome, gastroesophageal reflux, hiatal hernia, aortic dissection, pulmonary embolism, mediastinal hematoma, etc;
• history of specific bleeding or bleeding caused by warfarin;
• patients who have undergone surgery (not including PCI) within the last 4 weeks and are prone to bleeding;
• patients who are known or suspected to be allergic to the drug in this study or are allergic constitution;
• drug abusers who have a history of alcohol abuse or drug dependence in the past 2 years;

Lab values

• clinically significant complications, including liver dysfunction (ALT or AST level more than 2 times higher than normal), renal dysfunction (serum creatinine level 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;

Age

• women of child-bearing age who do not agree to use contraception during the medication phase;

Other

• women who are pregnant or preparing to be pregnant or nursing, menstruating women;
• patients with severe anxiety (Hamilton Anxiety Scale score more than 21);
• patients with severe depression (Hamilton Depression Scale score not less than 24);
• psychopath;
• patients who have been judged by their doctors to be ineligible for the study;
• patient who is a family member or relative of the staff working in the centers.

• male or female aged 18-85 years;
• patients with a history of percutaneous coronary intervention for coronary heart disease for more than 30 days and less than 180 days, without need of further elective coronary revascularization (PCI, CABG) judged by cardiovascular specialists;
• patients with symptoms such as chest distress, chest pain, palpitation, pain in shoulder and back, shortness of breath, weakness, activity intolerance, etc. Angina frequency (AF) score in Seattle Angina Questionnaire (SAQ) no more than 80;
• Hamilton Anxiety Scale score between 7 and 21 (mild to moderate anxiety);
• written informed consent.