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.
Age range of 18-75 years, encompassing both genders;
Patients presenting with an initial clinical diagnosis of acute ST-segment elevation myocardial infarction (STEMI), within a maximum time frame of 12 hours from the onset of pain to consideration for trial inclusion, who fulfill the criteria for percutaneous coronary intervention (PCI) and express their intention to undergo PCI;
The subject and their legal representative possess the capacity and willingness to provide informed consent by signing.
Uncontrolled hypertension (systolic blood pressure≥200mmHg and/or diastolic blood pressure≥110mmHg);
Previous PCI or CABG;
Long-term use of loading doses of anticoagulant or antiplatelet drugs;
History of hemorrhagic stroke or ischemic stroke within 6 months, peptic ulcer, prolonged cardiopulmonary resuscitation (more than 10 minutes) within the last 6 weeks, surgery, or major trauma;
Parallel
Butylphthalide
DrugSubjects 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
DrugButylphthalide 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.
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).
The changes of ST-segment resolution in electrocardiogram
ST-segment resolution of electrocardiogram at 7±2 days and 30±2 days after 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.
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.
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Xiangya Hospital of Central South University
Lead sponsor
CSPC Pharmaceutical Group Limited
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
