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SHENNONG:A Real-world, Prospective, Observational Study Assessing the Effectiveness of Repatha® Used in Combination with Standard of Care Compared with Standard of Care Alone on Major Cardiovascular Events in Chinese Patients with Established Atherosclerotic Cardiovascular Disease

A Real-world, Prospective, Observational Study Assessing the Effectiveness of Repatha® Used in Combination with Standard of Care Compared with Standard of Care Alone on Major Cardiovascular Events in Chinese Patients with Established Atherosclerotic Cardiovascular Disease

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400088942
Enrollment
Unknown
Registered
2024-08-29
Start date
2024-03-29
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ASCVD

Interventions

standard therapy:NA
Evolocumab in combination with standard therapy:NA

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1: Male or female >= 18 to= 85 years of age; 2: Patients or patient’s legally authorized representative has provided informed consent to participate in this study; 3: Patients with established ASCVD prescribed with Repatha in combination with SOC or with SOC alone, according to local guidelines and approved label; 4: Patients with one of the following : A past MI or ischemic stroke plus one of; Event in the past 2 years o Multiple prior events; Documented multivessel coronary disease; Type 2 diabetes mellitus (T2DM) OR Symptomatic peripheral arterial disease (PAD); 5: Most recent prior to enrollment fasting LDL-C >= 70 mg/dL (>= 1.8 mmol/L) or nonhigh- density lipoprotein cholesterol (non-HDL-C) >= 100 mg/dL (>= 2.6 mmol/L); 6: Most recent prior to enrollment fasting TG <= 400 mg/dL (<= 4.5 mmol/L);

Exclusion criteria

Exclusion criteria: 1: Stroke within past 1 month; 2: Past hemorrhagic stroke; 3: Stroke due to thromboembolic event (eg, atrial fibrillation patient without appropriate anticoagulation); 4: Any prior use of Repatha or other PCSK9 inhibition treatments within past 24 weeks; 5: New York Heart Association (NYHA) class III or IV, or last known left ventricular ejection fraction <30%;

Design outcomes

Primary

MeasureTime frame
CV Endpoint events;

Secondary

MeasureTime frame
LDL-C Change and Percentage Change from Baseline to End of Follow-Up;AE and ADR;

Countries

China

Contacts

Public ContactJianping Li

Peking University First Hospital

13521531013@163.com+86 10 8357 5728

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026