NCT06704685Not yet recruitingPhase 3
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 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.
Source: ClinicalTrials.gov · Last updated 26 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 21 Nov 2024
- Start date
- Dec 2024
- Primary completion date
- Oct 2025
- Lead sponsor
- Xiangya Hospital of Central South University
- Diseases
- Coronary artery disease
- NCT number
- NCT06704685
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 40
- From Dec 2024 to the primary completion date, Oct 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous PCI or CABG;
- Long-term use of loading doses of anticoagulant or antiplatelet drugs;
- 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 illness
- Uncontrolled hypertension (systolic blood pressure≥200mmHg and/or diastolic blood pressure≥110mmHg);
- 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;
- Severe mental disorder, alcohol dependence or inability to cooperate with informed consent and follow-up due to dementia;
Lab values
- 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);
Other
- Pregnancy, lactation, and planning to become pregnant within 30 days;
- Other reasons for not being eligible for the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.