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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
210
The 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.
The 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
Percentage of myocardial infarction size
Percentage of myocardial infarction size
Time frame: Day 4
Percentage of myocardial infarction size
Percentage of myocardial infarction size
Time frame: Day 30, Day 90
Percentage of microvascular obstruction area (MVO)
Percentage of microvascular obstruction area (MVO)
Time frame: Day 4, Day 30, Day 90
Myocardial salvage index
Myocardial salvage index
Time frame: Day 4
Left ventricular ejection fraction (LVEF)
Left ventricular ejection fraction (LVEF)
Time frame: Day 4, Day 90
Left ventricular end-systolic volume index (LVESVI)
Left ventricular end-systolic volume index (LVESVI)
Time frame: Day 4, Day 90
Left ventricular end-diastolic volume index (LVEDVI)
Left ventricular end-diastolic volume index (LVEDVI)
Time frame: Day 4, Day 90
Composite incidence of cardiovascular death
Composite incidence of cardiovascular death
Time frame: Day 90
Incidence of cardiovascular death
Incidence of cardiovascular death
Time frame: Day 90
Incidence of cardiac failure events
Incidence of cardiac failure events
Time frame: Day 90
safety endpoints
Adverse events (AEs)/serious adverse events (SAEs):physical examinations/vital signs/ECGs/laboratory tests
Time frame: within 90 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.