This is a randomized, double-blind, placebo-controlled, adaptive clinical trial, which will assess the effect of DanshenDuofensuanyan\[Danshen (a kind of Chinese herbal drug) extract\] treatment on Lipoprotein associated phospholipase A2 level in patients with stable angina pectoris.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
156
A kind of injection made from a kind of Chinese herb: salvia miltiorrhiza
200mg glugose added into 250ml 0.9% saline injection by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, using brown infusion tube for infusion.
Standard medical care is in accordance with China Guideline for the diagnosis and treatment of Chronic Stable Angina (2007).
Taizhou Fourth People's Hospital
Taizhou, Jiangsu, China
RECRUITINGSerum level of Lp-PLA2
Time frame: up to Day 60 after discharge
The proportion of patients in each treatment group who had clinically significant change as defined by the angina-frequency score on the Seattle Angina Questionnaire
Time frame: Day 0 and Day 60 after discharge
carotid arterial intima-media wall thickness
Time frame: Day0 and Day 60 after discharge
Canadian Cardiovascular Society (CCS) grading of angina pectoris
Time frame: Day 0 and Day 60 after discharge
Change in the electrocardiogram (EKG)
Time frame: Day 0 and Day 60 after discharge
Changes in the Serum Lipid, the high-sensitivity C-Reactive Protein(hs-CRP) and the Platelet Aggregation Rate
Time frame: Day 0 and Day 60 after discharge
Incidence of new-onset major vascular events
Major adverse vascular events include ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction and vascular-related death.
Time frame: up to 60 days after discharge
Incidence of severe hemorrhages
The definition of "Severe hemorrhages" is in accordance with the GUSTO bleeding criteria, including fatal intracranial hemorrhage (ICH), symptomatic intracerebral hemorrhage (sICH) or which could result in substantial hemodynamic compromise requiring treatment.
Time frame: up to 60 days after discharge
Incidence of moderate hemorrhages
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The definition of "moderate hemorrhages" is in accordance with the GUSTO bleeding criteria, which requires blood transfusion but not results in hemodynamic compromise.
Time frame: up to 60 days after discharge