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

NCT ID: NCT06704685

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2025-12-31

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.

Conditions

ST-segment Elevation Myocardial Infarction (STEMI)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Butylphthalide

Intervention Type: DRUG

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.

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.

Group Type: PLACEBO_COMPARATOR

Butylphthalide placebo

Intervention Type: DRUG

Butylphthalide placebo

Interventions

Butylphthalide

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.

Intervention Type: DRUG

Butylphthalide placebo

Butylphthalide placebo

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSPC Pharmaceutical Group Limited

INDUSTRY

Sponsor Role: collaborator

Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Le Zhang

Role: CONTACT

zlzdzlzd@csu.edu.cn

86+13973187150

Other Identifiers

202409176

Identifier Type: -

Identifier Source: org_study_id