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

Phase 3

Not yet recruiting

• Conditions: ST-segment Elevation Myocardial Infarction (STEMI)
• Interventions: Drug: Butylphthalide; Drug: Butylphthalide placebo

• Registration Number: NCT06704685
• Lead Sponsor: Xiangya Hospital of Central South University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-21
• Study First Submitted QC: 2024-11-25
• Last Update Submitted: 2024-11-25
• Study First Posted: 2024-11-26
• Last Update Posted: 2024-11-26
• Study Start: 2024-12-01
• Primary Completion: 2025-10-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Butylphthalide group	Butylphthalide	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.
Placebo group	Butylphthalide placebo	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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.
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 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.
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.