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NCT07306182RecruitingPhase 2

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

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)

Source: ClinicalTrials.gov · Last updated 13 Jul 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
210 (estimated)
First submitted
24 Dec 2025
Start date
9 Mar 2026
Primary completion date
30 Apr 2027
Lead sponsor
Beijing Sungen Biomedical Technology Co., Ltd
NCT number
NCT07306182

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 210
  • From 9 Mar 2026 to the primary completion date, 30 Apr 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who have received thrombolysis;
  • Febrile infection requiring systemic treatment within 2 weeks prior to screening;
  • Concomitant left bundle branch block;
  • Concomitant severe arrhythmia (including high-degree atrioventricular block, sick sinus syndrome, sustained ventricular tachycardia, etc.) or implanted cardiac pacemaker;

Other illness

  • 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;
  • 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;

Other

  • Patients with a life expectancy of less than 1 year;
  • Cardiogenic shock or hemodynamic instability;

Who the study is looking for

  • 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).

Age in the registry: 18 years to 79 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Shanghai East Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.