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

Amgen

Status: Enrolling

Conditions: Established Atherosclerotic Cardiovascular Disease; Major Cardiovascular Event

Study type: Observational

Funder types: Industry

Identifiers

NCT06295679

20180442

Details and patient eligibility

About

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.

Enrollment: 7,000 estimated patients

Sex: All

Ages: 18 to 150 years old

Volunteers: No 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.

Trial design

7,000 participants in 2 patient groups

Repatha® with Standard of Care Exposure

Description:

Participants with clinically evident ASCVD treated with Repatha® in combination with SOC in a clinical setting. To ensure that the recruitment strategy has as little impact on routine practice as possible, the decision to treat the participant with Repatha® with SOC will be made independently of, and before, enrollment in the study.

Standard of Care Exposure

Description:

Participants with clinically evident ASCVD treated with SOC alone in a clinical setting. To ensure that the recruitment strategy has as little impact on routine practice as possible, the decision to treat the participant with SOC only will be made independently of, and before, enrollment in the study.