A Study Assessing Repatha® in Combination With Standard of Care (SOC) Compared With SOC on Major Cardiovascular Events in Chinese Participants With 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

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06295679

Enrollment

7000

Registered

2024-03-06

Start date

2022-12-19

Completion date

2028-12-19

Last updated

2026-09-04

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

Conditions

Established Atherosclerotic Cardiovascular Disease, Major Cardiovascular Event

Keywords

Cardiovascular death, Myocardial infarction, Stroke, Unstable angina, Coronary revascularization, Atherosclerotic Cardiovascular Disease, Repatha

Brief summary

The primary objective of the study is to evaluate real-world effectiveness of treatment with Repatha® in combination with SOC, compared with SOC alone, on the risk for cardiovascular (CV) death, myocardial infarction (MI), stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in participants with established atherosclerotic CV disease (ASCVD) treated with SOC, according to local clinical practice.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 150 Years

Healthy volunteers

Inclusion criteria

* Adult participants ≥ 18 years of age. * Participants or participant's legally authorized representative has provided informed consent to participate in this study. * Participants who meet one of the following: * Prescribed Repatha® in addition to an existing SOC treatment according to local guidelines and approved label. OR * Already received SOC treatment prior to enrollment. * Participants with ANY of the following. * Diagnosis of MI OR stroke within 2 years before enrollment. * 2 MIs OR ≥ 2 strokes OR (≥ 1 MI AND ≥ 1 stroke) any time before enrollment. * Diagnosis of (MI OR stroke) AND diabetes. * Diagnosis of (MI OR stroke) AND documented multivessel disease (defined as \> 50% stenosis of ≥ 2 major coronary arteries on coronary angiography or coronary artery contrast enhanced computed tomography). * Diagnosis of symptomatic peripheral arterial disease. * Most recent 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) within 6 months prior to enrollment. * Most recent fasting triglycerides ≤ 400 mg/dL (≤ 4.5 mmol/L) within 6 months prior to enrollment.

Exclusion criteria

* Stroke within past 1 month. * Known hemorrhagic stroke at any time. * Stroke due to thromboembolic event. * Any prior use of Repatha® or other proprotein convertase subtilisin/kexin type 9 inhibition treatments within past 6 months prior to enrollment. * Participants currently enrolled in another study involving any investigational procedure, device or drug. * Participants prescribed Repatha® with a history of severe hypersensitivity or allergy to any subsidiary.

Design outcomes

Primary

Measure	Time frame
Time to CV Death, MI, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization, Whichever Occurs First	Up to 72 months

Secondary

Measure	Time frame
Time to CV Death, MI, or Stroke, Whichever Occurs First	Up to 72 months
Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline	Baseline and end of follow-up (up to 72 months)
Percent Change in LDL-C From Baseline	Baseline and end of follow-up (up to 72 months)
Number of Participants Who Experienced Adverse Events	Up to 72 months
Number of Participants Who Experienced Adverse Drug Reactions	Up to 72 months

Countries

China

Contacts

STUDY_DIRECTORMD

Amgen

Outcome results