Status:
COMPLETED
Efficacy and Safety Study of Thymosin Beta 4 in Patients With Acute Myocardial Infarction
Lead Sponsor:
Beijing Northland Biotech. Co., Ltd.
Conditions:
Acute Myocardial Infarction
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
A multicenter randomized double-blind placebo parallel control design was used in this study. The 90 participants were randomly assigned to placebo, 0.5μg/kg dose group, and 1.0μg/kg dose group in a r...
Detailed Description
Cardiovascular magnetic resonance imaging (CMR) was performed on day 5 and day 90 after PCI to evaluate myocardial infarction size, microvascular obstruction area, left ventricular ejection fraction (...
Eligibility Criteria
Inclusion
- The subjects or their guardians voluntarily participate in the experiment and sign the informed consent;
- Age ≥18 years old and ≤75 years old, gender is not limited;
- STEMI patients with proximal or/and middle occlusion of a single left anterior descending artery (TIMI grade 0-1) and PCI;
- No coronary collateral (Rentrop grade 0);
- meet one of the following conditions:
- The total myocardial ischemia time before PCI was \< 6 hours, and the TIMI grade after PCI was \< 3
- 6 hours ≤ Total myocardial ischemia time before PCI ≤24 hours Note: Total myocardial ischemia time =PCI wire passage time - start time of chest pain
- All subjects (male and female) must agree to use appropriate contraceptive methods (hormonal or barrier methods, abstinence) during study participation and up to 6 months of the last dosing, and women of childbearing age must test negative for pregnancy before dosing.
Exclusion
- Patients with a history of myocardial infarction who have received acute coronary thrombolysis, interventional therapy, or bypass surgery; A clear diagnosis of acute heart failure (Killip grade ≥III);
- Severe arrhythmias that cannot be corrected;
- Aortic dissection;
- Severe liver and kidney dysfunction or severe consumption;
- History of major surgery or hemorrhagic stroke within six months;
- Previous history of malignant tumors;
- Hypertensive patients with systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg after active antihypertensive treatment;
- Clinically significant allergic reaction history, especially mannitol, drugs, protein preparations, biological products;
- Patients who participated in other clinical studies within 3 months prior to screening;
- Can not perform CMR examination;
- Other conditions deemed unsuitable for inclusion by the investigators (for example, those whose coronary arteries other than the left anterior descending branch were judged by the investigators to require elective revascularization therapy at the same time or within 1 month).
Key Trial Info
Start Date :
July 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 29 2023
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05984134
Start Date
July 15 2022
End Date
May 29 2023
Last Update
June 21 2024
Active Locations (1)
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1
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, China