Clinical trial NCT06704685: 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
Official title: 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: ST-segment Elevation Myocardial Infarction (STEMI)
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
Collaborators: name: CSPC Pharmaceutical Group Limited
First posted: 2024-11-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The subjects will be randomly assigned in a 1:1 ratio to two groups: a butylphthalide group and a placebo 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. The placebo group received the same dosage of butylphthalide injection and soft capsules placebo.
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Age range of 18-75 years, encompassing both genders;
2. 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;
3. The subject and their legal representative possess the capacity and willingness to provide informed consent by signing.

Exclusion Criteria:

1. Uncontrolled hypertension (systolic blood pressure≥200mmHg and/or diastolic blood pressure≥110mmHg);
2. Previous PCI or CABG;
3. Long-term use of loading doses of anticoagulant or antiplatelet drugs;
4. 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;
5. Known allergy to butylphthalide or excipients;
6. 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;
7. 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);
8. Pregnancy, lactation, and planning to become pregnant within 30 days;
9. Severe mental disorder, alcohol dependence or inability to cooperate with informed consent and follow-up due to dementia;
10. Concurrent malignant tumor or severe systemic disease with expected survival time less than 30 days;
11. Have participated in or are currently participating in another clinical intervention study within 30 days before randomization;
12. Other reasons for not being eligible for the study.

Primary outcomes:
measure: The efficacy in reducing myocardial infarct size in subjects with STEMI after primary PCI
timeFrame: 30±2 days post-randomization
Secondary outcomes:
measure: The proportion of no-reflow and severe slow flow events
timeFrame: 30±2 days post-randomization
measure: The changes of ST-segment resolution in electrocardiogram
timeFrame: 7±2 days and 30±2 days post-randomization
measure: CMR imaging cardiac function indexes and cardiac color Doppler ultrasound related indexes
timeFrame: 30±2 days post-randomization
measure: The decline of myocardial enzyme indexes
timeFrame: 7±2 days and 30±2 days post-randomization
measure: Proportion of combined vascular events
timeFrame: 30±2 days post-randomization
Other outcomes:
Locations:
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