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The purpose of the study is to evaluate the impact of HRS9531 on major adverse cardiovascular events (MACE) in patients with atherosclerotic cardiovascular disease. This study adopts an event-driven design and ends when the target number of the primary endpoint event is reached.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS9531 Group A | Experimental |
| |
| HRS9531 placebo Group B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS9531 | Drug | HRS9531 Dose 1 , subcutaneous injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The time from randomization to the first occurrence of the MACE-3 composite endpoint | approximately up to 61 months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Time to the first occurrence of the MACE-4 composite endpoint | approximately up to 61 months of treatment | |
| Time to the first occurrence of the extended MACE composite endpoint | approximately up to 61 months of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sheng Qi | Contact | +8613482562074 | Sheng.qi@hengrui.com |
| Name | Affiliation | Role |
|---|---|---|
| Kefei Dou | Chinese Academy of Medical Sciences, Fuwai Hospital | Principal Investigator |
| Xiao Wang | Chinese Academy of Medical Sciences, Fuwai Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital, CAMS&PUMC | Recruiting | Beijing | Beijing Municipality | 100037 | China |
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| HRS9531 placebo |
| Drug |
HRS9531 placebo Dose 1, subcutaneous injection |
|
| Time to the first occurrence of the composite endpoint of heart failure； | approximately up to 61 months of treatment |
| Time to the first occurrence of the composite endpoint of kidney disease； | approximately up to 61 months of treatment |
| Time to the first occurrence of the composite endpoint of major adverse limb events； | approximately up to 61 months of treatment； |
| Time when each component event of the MACE-3 composite endpoint occurred for the first time | approximately up to 61 months of treatment； |
| Time when all-cause death occurs； | approximately up to 61 months of treatment； |
| Time to the first hospitalization due to heart failure； | approximately up to 61 months of treatment； |
| Time to the first emergency heart failure visit； | approximately up to 61 months of treatment； |
| Time when the first persistent eGFR decreased by ≥50% from baseline； | approximately up to 61 months of treatment； |
| Time when persistent eGFR < 15 mL/min/1.73m2 occurred for the first time； | approximately up to 61 months of treatment； |
| Time to first entering chronic renal replacement therapy (dialysis or kidney transplantation) ； | approximately up to 61 months of treatment； |
| The time when renal death occurs； | approximately up to 61 months of treatment； |
| Time to hospitalization for the first occurrence of acute limb ischemia； | approximately up to 61 months of treatment； |
| Time to hospitalization for the first occurrence of unplanned chronic limb ischemia； | approximately up to 61 months of treatment |
| Incidence and severity of adverse events ; | Approximately 61 months |
| Change from baseline in body weight; | From randomization to 104 weeks |
| Change from baseline in waistline; | From randomization to 104 weeks |
| Change from baseline in glycosylated hemoglobin; | From randomization to 104 weeks |
| Change from baseline in blood lipid parameter; | From randomization to 104 weeks |
| Change from baseline in blood pressure; | From randomization to 104 weeks |
| Change from baseline in glomerular filtration; | From randomization to 104 weeks |
| Change from baseline in Uric Acid; | From randomization to 104 weeks |
| Change from baseline in hsCRP; | From randomization to 104 weeks |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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