A Randomized Controlled Trial on the Efficacy and Safety of Butylphthalide in Reducing Myocardial Infarction Size and Improving Outcomes in STEMI Patients After Primary PCI - A Prospective, Multicenter, Randomized, Placebo, Double-blinded End Trial.
Overview
- Phase
- Phase 3
- Intervention
- Butylphthalide
- Conditions
- ST-segment Elevation Myocardial Infarction (STEMI)
- Sponsor
- Xiangya Hospital of Central South University
- Enrollment
- 40
- Primary Endpoint
- The efficacy in reducing myocardial infarct size in subjects with STEMI after primary PCI
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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;
- •Known allergy to butylphthalide or excipients;
- •Patients with any of the following conditions: cardiogenic shock, chronic congestive heart failure NYHA class ≥III, severe hypotension, pulmonary insufficiency, severe hepatic and renal insufficiency;
- •History of congenital or acquired hemorrhagic diseases, coagulation factor deficiency diseases, thrombocytopenic diseases, etc. Or any of the following laboratory tests (INR \> 2.0, platelet count \< 100×109/L, Hb \< 10g/dl);
- •Pregnancy, lactation, and planning to become pregnant within 30 days;
- •Severe mental disorder, alcohol dependence or inability to cooperate with informed consent and follow-up due to dementia;
- •Concurrent malignant tumor or severe systemic disease with expected survival time less than 30 days;
Arms & Interventions
Butylphthalide group
The Butylphthalide group received 100ml of butylphthalide injection twice a day for 7±2 days, followed by butylphthalide soft capsules (2 capsules, three times a day) from the day of discharge to day 30±2.
Intervention: Butylphthalide
Placebo group
The placebo group received 100ml of butylphthalide placebo injection twice a day for 7±2 days, followed by butylphthalide placebo soft capsules (2 capsules, three times a day) from the day of discharge to day 30±2.
Intervention: Butylphthalide placebo
Outcomes
Primary Outcomes
The efficacy in reducing myocardial infarct size in subjects with STEMI after primary PCI
Time Frame: 30±2 days post-randomization
To evaluate the efficacy of butylphthalide injection versus placebo in reducing myocardial infarct size at day 30 in patients with STEMI after primary PCI.
Secondary Outcomes
- The proportion of no-reflow and severe slow flow events(30±2 days post-randomization)
- The changes of ST-segment resolution in electrocardiogram(7±2 days and 30±2 days post-randomization)
- CMR imaging cardiac function indexes and cardiac color Doppler ultrasound related indexes(30±2 days post-randomization)
- The decline of myocardial enzyme indexes(7±2 days and 30±2 days post-randomization)
- Proportion of combined vascular events(30±2 days post-randomization)