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Tests treatment safety and results for Acute Anterior ST-Segment Elevation Myocardial Infarction
Official title A Research Study to Evaluate the Efficacy and Safety of SGC001 in Patients With Anterior Wall ST-Segment Elevation Myocardial Infarction
ClinicalTrials.gov ID: NCT07306182
What this study is testing
What is SGC001 injection?
SGC001 injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute anterior st-segment elevation myocardial infarction.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 79
You may be able to join if
- 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...
- 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...
You likely can't join if
- History of the following cardiac conditions:
- History of myocardial infarction, coronary revascularization (including percutaneous coronary intervention [PCI] and coronary artery bypass grafting...
- 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;
See the full eligibility 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...
- 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...
- 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;
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.