Cardiovascular diseases
Conditions
Interventions
Alirocumab group:Nil
Sponsors
Zhongshan Hospita of Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Recent (within 52 weeks of alirocumab treatment Index initiation) ACS requiring hospitalization. 2. Patient was initiated on alirocumab within last 4 weeks (Index Initiation). Alirocumab treatment should be given in compliance with the Chinese package insert (PI), solely determined by the treating physician and independently of the patient's enrollment in the present study.
Exclusion criteria
Exclusion criteria: 1. Reated with other proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor and other investigational drug within 28 days or five half-lives before inclusion, whichever is longer; 2. Having contraindication to alirocumab as those described in the approved Chinese package insert(PI); 3. With any severe life-threatening conditions, including severe hepatic impairment and persistent serum transaminases increases, severe renal failure; 4. With history of renal transplantation, heart transplantation; 5. Females who are pregnant, lactating or planning to become pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first occurrence of any of the following clinical events: nonfatal MI, nonfatal ischemic stroke, CV death, and coronary revascularization (4-part MACE); | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to first occurrence of any of the following clinical events: nonfatal MI, nonfatal ischemic stroke, CV death (3-part MACE);Time to first occurrence of any of the following clinical events: nonfatal MI, nonfatal ischemic stroke, and all-cause death (3-part MACE);Time to first occurrence of the following clinical events: nonfatal MI, nonfatal ischemic stroke, CV death, all-cause death, and coronary revascularization;Percent change in LDL-C from baseline to month 1,3,6,12,18,24,36 and 48;Adverse events (AEs) including treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs); | — |
Countries
China
Contacts
Public ContactHe Jing
Sanofi (China) Investment Co., Ltd. Shanghai B
Outcome results
None listed