ST-segment Elevation Myocardial Infarction (STEMI)
Conditions
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.
Interventions
DRUGButylphthalide
Subjects 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
Sponsors
CSPC Pharmaceutical Group Limited
Xiangya Hospital of Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The efficacy in reducing myocardial infarct size in subjects with STEMI after primary PCI | 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
| Measure | Time frame | Description |
|---|---|---|
| The changes of ST-segment resolution in electrocardiogram | 7±2 days and 30±2 days post-randomization | ST-segment resolution of electrocardiogram at 7±2 days and 30±2 days after randomization. |
| The decline of myocardial enzyme indexes | 7±2 days and 30±2 days post-randomization | Myocardial enzyme indexes (CK-MB, troponin I or T) decline at 7±2 days and 30±2 days of randomization. |
| CMR imaging cardiac function indexes and cardiac color Doppler ultrasound related indexes | 30±2 days post-randomization | 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 proportion of no-reflow and severe slow flow events | 30±2 days post-randomization | 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). |
| Proportion of combined vascular events | 30±2 days post-randomization | Rate of combined vascular events (symptomatic stroke, recurrent myocardial infarction, vascular death) at 30±2 days after randomization. |
Contacts
Primary ContactLe Zhang
Outcome results
None listed