unstable angina pectoris
Conditions
Interventions
Intervention group:Xueshuantong Injection 500mg, ivggt, qd + conventional therapy
Control Group:Xueshuantong Injection 25mg, ivggt, qd + conventional therapy
Sponsors
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed with coronary heart diseaseand meet at least one of the following diagnostic criteria: 1) Prior history of MI; 2) Have received coronary revascularization procedure(PCI or CABG); 3) Angiographic evidence of the presence of =50% stenosis of at least one coronary artery; 3) Imaging evidence(MR or Myocardial Perfusion Imaging) of myocardial ischemia; 2. Diagnosed with coronary heart diseaseand meet at least one of the following diagnostic criteria; 1) Transient or continuous ST elevation = 0.1 mV in one or more leads on ECG; 2) TIMI grade = 3; 3) Undergoing dual antiplatelet therapy ( aspirin plus clopidogrel or ticagrelor); 4) Aged between 40 and 75 years old male and female; 5) Diagnosed as TCM pattern of heart blood stasis; 6) Voluntary to participate and providing written informed consents, as required by GCP.
Exclusion criteria
Exclusion criteria: 1. Patients with heart failure of NYHA IV;or high-risk patients as results of the Rapid risk stratification of Unstable angina; 2. Uncontrolled blood pressure, with a systolic blood pressure =180 mmHg or a diastolic blood pressure=100 mmHg, combined with severe cardiopulmonary insufficiency,severe arrythmia,Severe primary hepatic, renal, hematologic, mental disorders or fatal disease like cancer; 3. High bleeding risk,such as history of hemorrage of vital organs (brain or upper gastrointestinal tract) within 6 months,low platelet counts,abnormal coagulation function,recent active hemorrhage,etc; 4. Serum level of ALT,AST or Scr >2 times upper limit of normal; GFR<60 ml/min/1.73m2; 5. Near-term plans for revascularization (PCI or CABG); 6. Allergic constitution,allergic to multiple food or drugs or allergic to the trial drug; 7. Pregnant, planning to pregnant or lactating women; 8. Participating another clinical trial within 1 month. 8. Not suitable in the study as the investigator determined.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, revascularization); | — |
Secondary
| Measure | Time frame |
|---|---|
| Therapeutic effect of unstable angina.;Syndrome features of Traditional Chinese Medicine.;All-cause mortality;Cardiovascular death;Non-fatal myocardial infarction; | — |
Countries
China
Contacts
Public ContactShao-xiang Xian, Zhong-qi Yang
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Outcome results
None listed