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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
9,262
HRS9531 Dose 1 , subcutaneous injection
HRS9531 placebo Dose 1, subcutaneous injection
Fuwai Hospital, CAMS&PUMC
Beijing, Beijing Municipality, China
RECRUITINGThe time from randomization to the first occurrence of the MACE-3 composite endpoint
Time frame: approximately up to 61 months of treatment
Time to the first occurrence of the MACE-4 composite endpoint
Time frame: approximately up to 61 months of treatment
Time to the first occurrence of the extended MACE composite endpoint
Time frame: approximately up to 61 months of treatment
Time to the first occurrence of the composite endpoint of heart failure;
Time frame: approximately up to 61 months of treatment
Time to the first occurrence of the composite endpoint of kidney disease;
Time frame: approximately up to 61 months of treatment
Time to the first occurrence of the composite endpoint of major adverse limb events;
Time frame: approximately up to 61 months of treatment;
Time when each component event of the MACE-3 composite endpoint occurred for the first time
Time frame: approximately up to 61 months of treatment;
Time when all-cause death occurs;
Time frame: approximately up to 61 months of treatment;
Time to the first hospitalization due to heart failure;
Time frame: approximately up to 61 months of treatment;
Time to the first emergency heart failure visit;
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Time frame: approximately up to 61 months of treatment;
Time when the first persistent eGFR decreased by ≥50% from baseline;
Time frame: approximately up to 61 months of treatment;
Time when persistent eGFR < 15 mL/min/1.73m2 occurred for the first time;
Time frame: approximately up to 61 months of treatment;
Time to first entering chronic renal replacement therapy (dialysis or kidney transplantation) ;
Time frame: approximately up to 61 months of treatment;
The time when renal death occurs;
Time frame: approximately up to 61 months of treatment;
Time to hospitalization for the first occurrence of acute limb ischemia;
Time frame: approximately up to 61 months of treatment;
Time to hospitalization for the first occurrence of unplanned chronic limb ischemia;
Time frame: approximately up to 61 months of treatment
Incidence and severity of adverse events ;
Time frame: Approximately 61 months
Change from baseline in body weight;
Time frame: From randomization to 104 weeks
Change from baseline in waistline;
Time frame: From randomization to 104 weeks
Change from baseline in glycosylated hemoglobin;
Time frame: From randomization to 104 weeks
Change from baseline in blood lipid parameter;
Time frame: From randomization to 104 weeks
Change from baseline in blood pressure;
Time frame: From randomization to 104 weeks
Change from baseline in glomerular filtration;
Time frame: From randomization to 104 weeks
Change from baseline in Uric Acid;
Time frame: From randomization to 104 weeks
Change from baseline in hsCRP;
Time frame: From randomization to 104 weeks
The time to the first unplanned revascularization event
Time frame: approximately up to 61 months of treatment;
Time when the first persistent eGFR decreased by ≥40% from baseline;
Time frame: approximately up to 61 months of treatment