This study is a prospective, randomized, placebo-double-blind, multicenter clinical trial. The purpose of this study is to investigate whether "butylphthalide +PCI" combined treatment mode on the basis of traditional drug therapy could reduce myocardial infarct size, improve cardiac function and long-term prognosis of patients with acute myocardial infarction, and verify the drug safety of butylphthalide in the treatment of STEMI within the window period of 12 hours.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
Subjects who were initially diagnosed with STEMI and scheduled for PCI were randomly assigned to one of two groups in a 1:1 ratio: a butylphthalide group and a placebo group.
Butylphthalide placebo
The efficacy in reducing myocardial infarct size in subjects with STEMI after primary PCI
To evaluate the efficacy of butylphthalide injection versus placebo in reducing myocardial infarct size at day 30 in patients with STEMI after primary PCI.
Time frame: 30±2 days post-randomization
The proportion of no-reflow and severe slow flow events
The proportion of no-reflow and severe slow flow events on day 30±2 after randomization (TFG\<2 is defined as slow flow events and angiographic score).
Time frame: 30±2 days post-randomization
The changes of ST-segment resolution in electrocardiogram
ST-segment resolution of electrocardiogram at 7±2 days and 30±2 days after randomization.
Time frame: 7±2 days and 30±2 days post-randomization
CMR imaging cardiac function indexes and cardiac color Doppler ultrasound related indexes
CMR examination of microcirculation obstruction area, delayed enhancement phenomenon, left ventricular ejection fraction (LVEF%) and other CMR imaging cardiac function indicators and cardiac color Doppler ultrasound related indicators.
Time frame: 30±2 days post-randomization
The decline of myocardial enzyme indexes
Myocardial enzyme indexes (CK-MB, troponin I or T) decline at 7±2 days and 30±2 days of randomization.
Time frame: 7±2 days and 30±2 days post-randomization
Proportion of combined vascular events
Rate of combined vascular events (symptomatic stroke, recurrent myocardial infarction, vascular death) at 30±2 days after randomization.
Time frame: 30±2 days post-randomization
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