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

Launched by XIANGYA HOSPITAL OF CENTRAL SOUTH UNIVERSITY · Nov 25, 2024

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ClinConnect Summary

This clinical trial is looking at a medication called butylphthalide to see if it can help reduce the size of heart damage and improve recovery in patients experiencing a severe type of heart attack known as ST-segment elevation myocardial infarction (STEMI). The study will involve patients who are within 12 hours of their heart attack and are eligible for a procedure called percutaneous coronary intervention (PCI), which helps open blocked arteries. By combining butylphthalide with standard treatments, researchers hope to improve heart function and long-term health outcomes for these patients.

To be eligible for this trial, participants need to be between 18 and 75 years old and have a recent diagnosis of STEMI. They should also be willing to give their consent to participate in the study. However, certain health conditions, like uncontrolled high blood pressure or a history of severe heart or bleeding problems, may disqualify someone from joining. If you decide to participate, you will be randomly assigned to receive either butylphthalide or a placebo (a dummy treatment) along with your usual care, and you’ll be monitored for safety and health improvements throughout the study.

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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.