A Research Study to Evaluate the Efficacy and Safety of SGC001 in Patients With Anterior Wall ST-Segment Elevation Myocardial Infarction

Официальное название

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)

Обзор

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).

Подробное описание

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.

Вмешательства

• Препарат SGC001 injection
  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)
• Препарат SGC001 injection
  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)
• Препарат Placebo
  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)

Первичные конечные точки

• Percentage of myocardial infarction size(ratio of infarct mass to left ventricular mass) [Срок оценки: Day 4 post-dosing]

Вторичные конечные точки (10)

• Percentage of myocardial infarction size [Срок оценки: Day 90 post-dosing]
• Percentage of microvascular obstruction area (MVO) [Срок оценки: Day 4 and Day 90 post-dosing]
• Myocardial salvage index [Срок оценки: Day 4 post-dosing]
• Left ventricular ejection fraction (LVEF), left ventricular end-systolic volume index (LVESVI), and left ventricular end-diastolic volume index (LVEDVI) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: Within 90 days post-dosing]
• Incidence of cardiovascular death [Срок оценки: Within 90 days post-dosing]
• Incidence of heart failure events [Срок оценки: Within 90 days post-dosing]
• Safety endpoints [Срок оценки: Within 90 days post-dosing]

Критерии участия

Критерии включения

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).

Критерии исключения

• 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;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai East Hospital — Шанхай

Идентификаторы

NCT: NCT07306182 · SG-SGC001-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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