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

ConditionAcute Anterior 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

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

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 within 6 months;

Presence of severe cardiac structural abnormalities such as aortic dissection, and ventricular aneurysm;

Trial design

Design model

Parallel

Treatments tested in this trial

  • SGC001 injection

    Drug

    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)

  • SGC001 injection

    Drug

    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)

  • Placebo

    Drug

    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)

Treatment groups

210 Participants
are divided into 3 treatment groups
Group A: Test Group 1Experimental treatment 1 intervention
Group B: Test Group 2Experimental treatment 1 intervention
Group C: Control GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of myocardial infarction size(ratio of infarct mass to left ventricular mass)

Time frame
Day 4 post-dosing

Secondary outcomes

1

Percentage of myocardial infarction size

Time frame
Day 90 post-dosing
2

Percentage of microvascular obstruction area (MVO)

Time frame
Day 4 and Day 90 post-dosing
3

Myocardial salvage index

Time frame
Day 4 post-dosing
4

Left ventricular ejection fraction (LVEF), left ventricular end-systolic volume index (LVESVI), and left ventricular end-diastolic volume index (LVEDVI)

Time frame
Day 4 and Day 90 post-dosing

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Sungen Biomedical Technology Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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