A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Characteristics of SGC001 Injection in Chinese Patients With Anterior Wall ST-Segment Elevation Myocardial Infarction and Planned for Primary Percutaneous Coronary Intervention (pPCI)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Percentage of myocardial infarction size(ratio of infarct mass to left ventricular mass)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.18-79 years of age (including boundary values), male or female;
- •2.Anterior wall STEMI: (a) history of persistent chest pain/precordial discomfort (>30 minutes); (b) upon admission, the ECG must meet the following requirements: i.For male participants >40 years old, ST-segment elevation ≥2 mm in leads V2 and V3; ii.For male participants ≤40 years old, ST-segment elevation ≥2.5 mm in leads V2 and V3; iii.For female participants, ST-segment elevation ≥1.5 mm in leads V2 and V3; If clinical symptoms of (a) are atypical, then (c) a positive point-of-care troponin test is required.
- •3.Planned for pPCI treatment;
- •4.Assessed as being able to complete dosing within 6 hours of the onset of persistent chest pain/precordial discomfort symptoms;
- •5.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).
排除标准
- •History of the following cardiac conditions:
- •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 within 6 months;
- •Presence of severe cardiac structural abnormalities such as aortic dissection, and ventricular aneurysm;
- •Patients who have received thrombolysis;
- •Patients with a life expectancy of less than 1 year;
- •Febrile infection requiring systemic treatment within 2 weeks prior to screening;
- •Concomitant left bundle branch block;
- •Cardiogenic shock or hemodynamic instability;
- •Concomitant severe arrhythmia (including high-degree atrioventricular block, sick sinus syndrome, sustained ventricular tachycardia, etc.) or implanted cardiac pacemaker;
- •Definitive diagnosis of acute heart failure (Killip classification ≥ III; for details on Killip classification, see Appendix);
- •Unable to undergo cardiac magnetic resonance (CMR) imaging according to the study protocol, or known allergy to any radiocontrast agent;
研究组 & 干预措施
Test Group 1
SGC001 injection 600 mg single dose
干预措施: SGC001 injection (Drug)
Test Group 2
SGC001 injection 900 mg single dose
干预措施: SGC001 injection (Drug)
Control Group
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of myocardial infarction size(ratio of infarct mass to left ventricular mass)
时间窗: Day 4 post-dosing
Percentage of myocardial infarction size
时间窗: Day 4
Percentage of myocardial infarction size
次要结局
- Percentage of microvascular obstruction area (MVO)(Day 4, Day 30, Day 90)
- Left ventricular ejection fraction (LVEF)(Day 4, Day 90)
- Left ventricular end-systolic volume index (LVESVI)(Day 4, Day 90)
- Left ventricular end-diastolic volume index (LVEDVI)(Day 4, Day 90)
- Composite incidence of cardiovascular death(Day 90)
- Incidence of cardiovascular death(Day 90)
- Incidence of cardiac failure events(Day 90)
- Percentage of myocardial infarction size(Day 90 post-dosing)
- Percentage of microvascular obstruction area (MVO)(Day 4 and Day 90 post-dosing)
- Myocardial salvage index(Day 4 post-dosing)
- Left ventricular ejection fraction (LVEF), left ventricular end-systolic volume index (LVESVI), and left ventricular end-diastolic volume index (LVEDVI)(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)(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)(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(Within 90 days post-dosing)
- Incidence of cardiovascular death(Within 90 days post-dosing)
- Incidence of heart failure events(Within 90 days post-dosing)
- Safety endpoints(Within 90 days post-dosing)
- Myocardial salvage index(Day 4)
- Percentage of myocardial infarction size(Day 30, Day 90)
- Left ventricular end-diastolic volume index (LVEDVI)(Day 4, Day 90)
- Percentage of microvascular obstruction area (MVO)(Day 4, Day 30, Day 90)
- Left ventricular ejection fraction (LVEF)(Day 4, Day 90)
- Left ventricular end-systolic volume index (LVESVI)(Day 4, Day 90)
- Composite incidence of cardiovascular death(Day 90)
- Incidence of cardiovascular death(Day 90)
- safety endpoints(within 90 days)
- Incidence of cardiac failure events(Day 90)