Myocardial Reperfusion Injury Clinical Trial
Official title:
Efficacy and Safety Evaluation of Phosphatidyl Choline Cu/Zn Superoxide Dismutase (PC-SOD) for Injection in Reducing Myocardial Reperfusion Injury: a Multicenter, Randomized, Single-blind, Placebo-controlled Dose-finding Study
The current study aims to evaluate different doses of PC-SOD injections for efficacy and safety in comparison to placebo, in order to provide a basis for future clinical trials in terms of experimental design and dose selection.
The study is a randomized, single-blind, multi-center, placebo-controlled trial to
preliminarily evaluate the efficacy and safety of PC-SOD, and to provide a basis for dose
selection in the next stage of study.
For each participant, the trial will be divided into the screening/treatment (screening and
treatment conducted during the first visit, 0 d) and safety follow-up (1 - 30 d) stages.
The study will screen 120 eligible subjects. After successful screening, the subjects will be
randomly assigned into four groups of equal size, including the 40 mg PC-SOD, 80 mg PC-SOD,
160 mg PC-SOD and placebo control groups. Subjects in each group will be administered the
corresponding intervention, followed by PCI treatment. During the safety follow-up stage, the
subjects will receive basic treatment based on Guidelines for Management of Patients with
ST-segment elevation myocardial infarction. Treatments will include dual anti-platelet
therapy, beta-blockers, ACEI/ARB (angiotensin-converting enzyme inhibitor/ angiotensin
receptor blocker), statins, anticoagulants, and so on.
By comparing the efficacy and safety endpoints of patients in the experimental and placebo
control groups, the study aims to preliminarily evaluate the efficacy and safety of different
doses of PC-SOD in reducing myocardial reperfusion injury.
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