About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Butylphthalide
- Butylphthalide placebo
Treatment groups
Locations
Sponsors and collaborators
Xiangya Hospital of Central South University
Lead sponsor
CSPC Pharmaceutical Group Limited
Collaborator