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Not yet recruiting NCT06704685

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 III Interventional ST-segment Elevation Myocardial Infarction (STEMI)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Butylphthalide, Butylphthalide placebo.
Who it may be relevant to
Registry conditions: ST-segment Elevation Myocardial Infarction (STEMI). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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 - A Prospective, Multicenter, Randomized, Placebo, Double-blinded End Trial.

Overview

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

  • Drug 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.
  • Drug Butylphthalide placebo
    Butylphthalide placebo

Primary outcome measures

  • The efficacy in reducing myocardial infarct size in subjects with STEMI after primary PCI [Time frame: 30±2 days post-randomization]
Secondary outcome measures (5)
  • The proportion of no-reflow and severe slow flow events [Time frame: 30±2 days post-randomization]
  • The changes of ST-segment resolution in electrocardiogram [Time frame: 7±2 days and 30±2 days post-randomization]
  • CMR imaging cardiac function indexes and cardiac color Doppler ultrasound related indexes [Time frame: 30±2 days post-randomization]
  • The decline of myocardial enzyme indexes [Time frame: 7±2 days and 30±2 days post-randomization]
  • Proportion of combined vascular events [Time frame: 30±2 days post-randomization]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06704685 · 202409176

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗