This is a multicenter, randomized, double-blind, placebo-controlled, single-dose, Phase II clinical study to evaluate the efficacy, safety, and pharmacokinetic (PK) characteristics of SGC001 injection administered in addition to standard clinical care in Chinese patients with acute anterior ST-segment elevation myocardial infarction (STEMI) who are planned for primary percutaneous coronary intervention (pPCI).
The study drug will be administered intravenously within 6 hours of the onset of acute myocardial infarction symptoms, on top of standard of care. The primary efficacy endpoint is the percentage of myocardial infarction size on Day 4 post-dosing, assessed by cardiac magnetic resonance (CMR) imaging. Secondary endpoints include myocardial infarction size at Day90, microvascular obstruction area and left ventricular function parameters at Day4 and Day90, myocardial salvage index at Day4, biomarkers (hs-TnI, hs-CRP, CK-MBmass, NT-proBNP), and composite incidence of cardiovascular death or heart failure events within 90 days. Safety assessments include adverse events, serious adverse events, physical examinations, vital signs, ECGs, and laboratory tests. Participants will undergo follow-up visits at Days 30 and 90, with a telephone follow-up at Day 180 to record survival status and heart failure events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
210
Dosage: 600mg single dose The administration must be completed as early as possible within 6 hours after the onset of acute myocardial infarction symptoms and before PCI reperfusion (i.e., before guidewire crossing)
Dosage: 900mg single dose The administration must be completed as early as possible within 6 hours after the onset of acute myocardial infarction symptoms and before PCI reperfusion (i.e., before guidewire crossing)
Dosage: 0mg single dose The administration must be completed as early as possible within 6 hours after the onset of acute myocardial infarction symptoms and before PCI reperfusion (i.e., before guidewire crossing)
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGPercentage of myocardial infarction size(ratio of infarct mass to left ventricular mass)
Time frame: Day 4 post-dosing
Percentage of myocardial infarction size
Time frame: Day 90 post-dosing
Percentage of microvascular obstruction area (MVO)
Time frame: Day 4 and Day 90 post-dosing
Myocardial salvage index
Time frame: Day 4 post-dosing
Left ventricular ejection fraction (LVEF), left ventricular end-systolic volume index (LVESVI), and left ventricular end-diastolic volume index (LVEDVI)
Time frame: Day 4 and Day 90 post-dosing
High-sensitivity troponin I (hs-TnI), high-sensitivity C-reactive protein (hs-CRP), creatine kinase-MB mass (CK-MBmass)
Time frame: baseline (pre-dose), and at 1 hour, 8 hours, Day 2, Day 5, and Day 30 post-dosing
N-terminal pro-brain natriuretic peptide (NT-proBNP)
Time frame: baseline (pre-dose), and at 1 hour, 8 hours, Day 2, Day 5, Day 30, Day90 post-dosing
Composite incidence of cardiovascular death or heart failure events
Time frame: Within 90 days post-dosing
Incidence of cardiovascular death
Time frame: Within 90 days post-dosing
Incidence of heart failure events
Time frame: Within 90 days post-dosing
Safety endpoints
Adverse events (AEs)/serious adverse events (SAEs)/physical examinations/vital signs/ECGs/laboratory tests
Time frame: Within 90 days post-dosing
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