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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SGC001 | Experimental | Enrolled anterior STEMI patients will receive standard clinical treatment and a single dose of SGC001 on Day 1 (D1) according to their randomized dosing group. The study drug should be administered within 6 hours after the onset of acute myocardial infarction symptoms, with earlier administration preferred. The intravenous injection will be administered over 10 minutes. |
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| Placebo | Placebo Comparator | Enrolled anterior STEMI patients will receive standard clinical treatment and a single dose of placebo on Day 1 (D1) according to their randomized dosing group. The study drug should be administered within 6 hours after the onset of acute myocardial infarction symptoms, with earlier administration preferred. The intravenous injection will be administered over 10 minutes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of myocardial infarction size | Percentage of myocardial infarction size | Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of myocardial infarction size | Percentage of myocardial infarction size | Day 30, Day 90 |
| Percentage of microvascular obstruction area (MVO) | Percentage of microvascular obstruction area (MVO) |
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Inclusion Criteria:
Exclusion Criteria:
History of the following cardiac conditions:
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;
Left bundle branch block (QRS duration ≥0.12 seconds. Broad R waves in leads V5 and V6, with a notch or slurring at the top, and no preceding q wave. Broad S waves or rS patterns in leads V1 and V2. T waves in leads V5 and V6 are opposite in direction to the main QRS wave);
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 cardiac 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;
Participation in other drug clinical trials and use of other investigational drugs within 3 months before receiving the study drug;
Concomitant history of the following serious diseases:
Men and women of childbearing potential (WOCBP) who are fertile and have plans to conceive during the study period, as well as pregnant or lactating women;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Zhang, Bachelor | Contact | 010-50973600 | 010-50973600 | wei.zhang@sungenbiomed.com.cn |
| Mei Tong, Doctor | Contact | 010-50973600 | 010-50973600 | mei.tong@sungenbiomed.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linfen Central Hospital | Recruiting | Linfen | Shanxi | 041099 | China |
The individual participant data (IPD) will be shared when necessary
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| 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 |
|
| Day 4, Day 30, Day 90 |
| Myocardial salvage index | Myocardial salvage index | Day 4 |
| Left ventricular ejection fraction (LVEF) | Left ventricular ejection fraction (LVEF) | Day 4, Day 90 |
| Left ventricular end-systolic volume index (LVESVI) | Left ventricular end-systolic volume index (LVESVI) | Day 4, Day 90 |
| Left ventricular end-diastolic volume index (LVEDVI) | Left ventricular end-diastolic volume index (LVEDVI) | Day 4, Day 90 |
| Composite incidence of cardiovascular death | Composite incidence of cardiovascular death | Day 90 |
| Incidence of cardiovascular death | Incidence of cardiovascular death | Day 90 |
| Incidence of cardiac failure events | Incidence of cardiac failure events | Day 90 |
| safety endpoints | Adverse events (AEs)/serious adverse events (SAEs):physical examinations/vital signs/ECGs/laboratory tests | within 90 days |
| ID | Term |
|---|---|
| D056988 | Anterior Wall Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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