coronary heart disease
Conditions
Interventions
SYD group:SYD
placebo group:placebo
Sponsors
Beijing Hospital of Traditional Chinese Medicine affiliated with Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: Aged 18 to 85 years, diagnosed with unstable angina confirmed with coronary angiography that required elective PCI,diagnosed with Qi deficiency and Blood stasis syndrome of Traditional Chinese Medicine.
Exclusion criteria
Exclusion criteria: acute myocardial infarction (ST-segment elevation or non ST-segment elevation); typical stable effort angina; patients warranting emergency coronary angiography; patients with other factors influencing measurement of cardiac troponin T (cTnT) levels (such as myocarditis or cardiomyopathy); left ventricular ejection fraction two times the upper limit of normal); renal failure (creatinine > 3 mg/dL); known malignant tumor; female patients who were pregnant, lactating, or planning a pregnancy during the course of the study; history of intolerance or hypersensitivity to SYD; previous or current treatment with SYD or another TCM prescription; use medications for which co-administration with clopidogrel, aspirin, nitrates, or statins was contraindicated; and participation in any other studies involving investigational or marketed products within 1 month prior to entry in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the incidence of Shen-yuan-dan(SYD) in reducing the occurrence of periprocedural myocardial injury(PMI);the safety of Shen-Yuan-Dan(SYD) in reducing the occurrence of PMI; | — |
Secondary
| Measure | Time frame |
|---|---|
| the incidence of major adverse cardiovascular events (MACEs) at 30 days after PCI;the protective effect of SYD against PMI among different subgroups based on GRACE risk score; | — |
Countries
China
Contacts
Public ContactHongxu Liu
Beijing Hospital of Traditional Chinese Medicine affiliated with Capital Medical University
Outcome results
None listed