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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-79
SponsorBeijing Sungen Biomedical Technology Co., Ltd

About this trial

The research study is being done to see if SGC001 can be used to treat people scheduled to undergo percutaneous coronary intervention for Anterior ST-segment Elevation Myocardial Infarction. SGC001 might reduce the infarct size and inhibited inflammation, thereby preventing the incidence of major adverse cardiovascular events(MACE) events. Participants will either get SGC001 (active medicine) or placebo (a dummy medicine which has no effect on the body). Which treatment participants get is decided by chance. The chance of getting SGC001 or placebo is the same. The participant was administered intravenously once. SGC001 is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18-79 years of age (including boundary values), male or female;

Planned for pPCI treatment;

Assessed as being able to complete dosing within 6 hours of the onset of persistent chest pain/precordial discomfort symptoms;

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).

Disqualifiers

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;

Presence of severe cardiac structural abnormalities such as aortic dissection, and ventricular aneurysm (including new-onset ventricular aneurysm);

Trial design

Design model

Parallel

Treatments tested in this trial

  • SGC001

    Drug

    The single dose should be administered within 6 hours after the onset of acute myocardial infarction symptoms, with earlier administration preferred. The intravenous injection should be administered over 10 minutes.

  • Placebo

    Drug

    The single dose should be administered within 6 hours after the onset of acute myocardial infarction symptoms, with earlier administration preferred. The intravenous injection should be administered over 10 minutes. Other Name

Treatment groups

210 Participants
are divided into 2 treatment groups
Group A: SGC001Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of myocardial infarction size

Percentage of myocardial infarction size

Time frame
Day 4

Secondary outcomes

1

Percentage of myocardial infarction size

Percentage of myocardial infarction size

Time frame
Day 30, Day 90
2

Percentage of microvascular obstruction area (MVO)

Percentage of microvascular obstruction area (MVO)

Time frame
Day 4, Day 30, Day 90
3

Myocardial salvage index

Myocardial salvage index

Time frame
Day 4
4

Left ventricular ejection fraction (LVEF)

Left ventricular ejection fraction (LVEF)

Time frame
Day 4, Day 90

Other outcomes

Sponsors and contacts

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