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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-150
SponsorAmgen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult participants ≥ 18 years of age.

Participants or participant's legally authorized representative has provided informed consent to participate in this study.

Prescribed Repatha® in addition to an existing SOC treatment according to local guidelines and approved label.

Already received SOC treatment prior to enrollment.

Disqualifiers

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.

Trial population

The study population comprises Chinese participants with established ASCVD treated with Repatha® in combination with SOC or with SOC alone in a clinical setting which includes any primary through tertiary healthcare setting where Repatha® is prescribed.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

7,000 Participants
are grouped into 2 trial groups
Group A: Repatha® with Standard of Care Exposure
Group B: Standard of Care Exposure

Trial outcomes

Primary outcomes

1

Time to CV Death, MI, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization, Whichever Occurs First

Time frame
Up to 72 months

Secondary outcomes

1

Time to CV Death, MI, or Stroke, Whichever Occurs First

Time frame
Up to 72 months
2

Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline

Time frame
Baseline and end of follow-up (up to 72 months)
3

Percent Change in LDL-C From Baseline

Time frame
Baseline and end of follow-up (up to 72 months)
4

Number of Participants Who Experienced Adverse Events

Time frame
Up to 72 months

Other outcomes

Sponsors and contacts

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