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

NCT06704685 | Not Yet Recruiting Phase 3

• 1 other identifier: 202409176
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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)

Outcome Measures

Primary Outcomes (1)

• The efficacy in reducing myocardial infarct size in subjects with STEMI after primary PCI

  To evaluate the efficacy of butylphthalide injection versus placebo in reducing myocardial infarct size at day 30 in patients with STEMI after primary PCI.

  30±2 days post-randomization

Secondary Outcomes (5)

• The proportion of no-reflow and severe slow flow events

  30±2 days post-randomization

• The changes of ST-segment resolution in electrocardiogram

  7±2 days and 30±2 days post-randomization

• CMR imaging cardiac function indexes and cardiac color Doppler ultrasound related indexes

  30±2 days post-randomization

• The decline of myocardial enzyme indexes

  7±2 days and 30±2 days post-randomization

• Proportion of combined vascular events

  30±2 days post-randomization

Study Arms (2)

Butylphthalide group

EXPERIMENTAL

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.

Drug: Butylphthalide

Placebo group

PLACEBO COMPARATOR

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.

Drug: Butylphthalide placebo

Interventions

Butylphthalide 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.

Butylphthalide group

Butylphthalide placebo DRUG

Butylphthalide placebo

Placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead
• CSPC Pharmaceutical Group Limited: collaborator

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

3-n-butylphthalide

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Central Study Contacts

Le Zhang

CONTACT

86+13973187150; zlzdzlzd@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 26, 2024
• Study Start: December 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: December 31, 2025
• Last Updated: November 26, 2024

Record last verified: 2024-11