SGC001 in STEMI patients undergoing PCI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled Phase II trial testing SGC001 in adults with acute anterior STEMI planned for primary PCI. The drug is given IV within 6 hours of symptom onset, in addition to standard care, and its safety, pharmacokinetics, and efficacy are measured by imaging and biomarkers. Primary outcome is infarct size at Day 4 by cardiac MRI, with additional follow-up through Day 180 to assess heart function and survival. Participants are evaluated for safety through adverse events, ECGs, and labs, with follow-up visits at Days 30 and 90 and a phone call at Day 180.

Why it matters

Who can join: the full rules

Inclusion Criteria

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).

Exclusion Criteria

1. History of the following cardiac conditions:

   1. History of myocardial infarction, coronary revascularization (including percutaneous coronary intervention \[PCI\] and coronary artery bypass grafting \[CABG\], etc.);
   2. History of cardiopulmonary resuscitation;
   3. History of stroke within 6 months;
   4. Presence of severe cardiac structural abnormalities such as aortic dissection, and ventricular aneurysm;
2. Patients who have received thrombolysis;
3. Patients with a life expectancy of less than 1 year;
4. Febrile infection requiring systemic treatment within 2 weeks prior to screening;
5. Concomitant left bundle branch block;
6. Cardiogenic shock or hemodynamic instability;
7. Concomitant severe arrhythmia (including high-degree atrioventricular block, sick sinus syndrome, sustained ventricular tachycardia, etc.) or implanted cardiac pacemaker;
8. Definitive diagnosis of acute heart failure (Killip classification ≥ III; for details on Killip classification, see Appendix);
9. Unable to undergo cardiac magnetic resonance (CMR) imaging according to the study protocol, or known allergy to any radiocontrast agent;

Where it's running

• Shanghai East Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Wei Gao, Doctor
• Email: wei.gao@sungenbiomed.com.cn
• Phone: 010-50973600

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.