About this trial
The research study is being done to see if SGC001 can be used to treat people scheduled to undergo percutaneous coronary intervention for Anterior ST-segment Elevation Myocardial Infarction. SGC001 might reduce the infarct size and inhibited inflammation, thereby preventing the incidence of major adverse cardiovascular events(MACE) events. Participants will either get SGC001 (active medicine) or placebo (a dummy medicine which has no effect on the body). Which treatment participants get is decided by chance. The chance of getting SGC001 or placebo is the same. The participant was administered intravenously once. SGC001 is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18-79 years of age (including boundary values), male or female;
Planned for pPCI treatment;
Assessed as being able to complete dosing within 6 hours of the onset of persistent chest pain/precordial discomfort symptoms;
The participant or their legal guardian fully understands the objectives, nature, methods, and potential adverse reactions of the study, voluntarily agrees to participate, and has signed the informed consent form (ICF).
Disqualifiers
History of myocardial infarction, coronary revascularization (including percutaneous coronary intervention [PCI] and coronary artery bypass grafting [CABG], etc.);
History of cardiopulmonary resuscitation;
History of stroke;
Presence of severe cardiac structural abnormalities such as aortic dissection, and ventricular aneurysm (including new-onset ventricular aneurysm);
Trial design
Parallel
Treatments tested in this trial
SGC001
DrugThe single dose should be administered within 6 hours after the onset of acute myocardial infarction symptoms, with earlier administration preferred. The intravenous injection should be administered over 10 minutes.
Placebo
DrugThe single dose should be administered within 6 hours after the onset of acute myocardial infarction symptoms, with earlier administration preferred. The intravenous injection should be administered over 10 minutes. Other Name
Treatment groups
Trial outcomes
Primary outcomes
Percentage of myocardial infarction size
Percentage of myocardial infarction size
Secondary outcomes
Percentage of myocardial infarction size
Percentage of myocardial infarction size
Percentage of microvascular obstruction area (MVO)
Percentage of microvascular obstruction area (MVO)
Myocardial salvage index
Myocardial salvage index
Left ventricular ejection fraction (LVEF)
Left ventricular ejection fraction (LVEF)
Sponsors and contacts
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