Coronary heart disease
Conditions
Interventions
Control group:Western medicine conventional standard treatment + Xinshubao Tablet Mimic (po 2 tablets per bid)
Experimental group:Western medicine conventional standard treatment + Xinshubao Tablets (po 2 tablets per bid)
Sponsors
First Affiliated Hospital of Zhejiang Chinese Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Patients who meet all of the following conditions can enter this trial: (1) The subjects must be able to understand the procedures and methods of this study be able to communicate well with the researchers be willing to strictly follow the clinical trial protocol to complete this trial and voluntarily sign the written informed consent form; (2) Age: 18 to 80 years old (including the boundary value) gender not limited; (3) Referring to the "Guidelines for the Diagnosis and Treatment of Stable Coronary Heart Disease" in 2018 (Atherosclerosis and Coronary Heart Disease Group Cardiovascular Branch of the Chinese Medical Association) it is in line with the diagnosis of stable angina pectoris of coronary heart disease; (4) Canadian Cardiovascular Society (CCS) Angina pectoris classification grades I to III; (5) During the screening period and the introduction period the average number of angina pectoris attacks per week was 2 to 7 times (including the boundary value); (6) It conforms to the syndrome of qi deficiency and blood stasis in traditional Chinese medicine.
Exclusion criteria
Exclusion criteria: (1) Other diseases that cause chest pain in combination such as cardiac neurosis pleurisy intercostal neuralgia pericarditis etc. (2) It is planned to take long-acting nitrates trimetazine nicorandil ivabry and other drugs to relieve angina pectoris symptoms of coronary heart disease within 4 weeks before screening or during the trial period (except for the stable use of beta-blockers and calcium channel blockers within 3 months before screening). (3) Acute myocardial infarction or pre-infarction symptoms occurred within 3 months prior to screening; Or there is a history of vascular reconstruction within 3 months before screening or vascular reconstruction is planned during the trial such as CABG or PCI; (4) Combined with severe heart disease malignant hypertension severe heart failure severe arrhythmia and other cardiovascular diseases; Or it may be combined with other serious or uncontrollable important organ or unstable systemic diseases such as cerebrovascular accidents uncontrollable diabetes uncontrollable active infections severe gastrointestinal diseases etc. (5) Abnormal liver and kidney functions during the screening period: Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =2×ULN total bilirubin (TBIL) =2×ULN serum creatinine (Cr) =2×ULN; (6) Allergy to the components of the drug under study allergic constitution or previous allergy to multiple drugs; (7) Combined with moderate to severe mental disorders such as depression and anxiety that require treatment with two or more drugs; (8) Alcohol-dependent individuals or those with a history of drug abuse within the past year; (9) Pregnant and lactating women and those who are planning to have a baby during the medication period or within three months after stopping the medication; (10) Participated in other interventional clinical researchers within 4 weeks prior to the trial; Other circumstances where the researcher deems it inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Angina pectoris frequency; | — |
Secondary
| Measure | Time frame |
|---|---|
| CCS classification of stable angina pectoris;The incidence of clinical cerebral hemorrhage events that can be known within one year after treatment;;Blood lipids: Total cholesterol (TC) triglycerides (TG) high-density lipoprotein cholesterol (HDL-C) low-density lipoprotein cholesterol (LDL-C);Seattle Angina Scale score;The syndrome score of qi deficiency and blood stasis in Traditional Chinese medicine;The dosage of emergency medication for angina pectoris;Biomarkers of myocardial fibrosis: Type III collagen amino-terminal peptide (P?NP) laminin (LN) hyaluronic acid (HA);Blood glucose: Fasting blood glucose (FPG) glycated hemoglobin (HbA1c);The incidence of composite cardiovascular and cerebrovascular endpoint events within one year of treatment (non-fatal stroke non-fatal myocardial infarction transient ischemic attack death from vascular diseases etc.);Angina pectoris frequency;6-minute walking test; | — |
Countries
China
Contacts
Public ContactHuang Shuwei
The First Affiliated Hospital of Zhejiang Chinese Medical University Zhejiang Provincial Hospital of Chinese Medicine
Outcome results
None listed