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

Recruiting

• Conditions: Major Cardiovascular Event; Established Atherosclerotic Cardiovascular Disease

• Registration Number: NCT06295679
• Lead Sponsor: Amgen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-19
• Study First Submitted: 2024-02-26
• Study First Submitted QC: 2024-03-04
• Study First Posted: 2024-03-06
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-02
• Last Update Posted: 2025-07-04
• Primary Completion: 2028-12-19
• Study Completion: 2028-12-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 7000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time to CV Death, MI, or Stroke, Whichever Occurs First	Up to 72 months
Percent Change in LDL-C From Baseline	Baseline and end of follow-up (up to 72 months)
Change in Low-density Lipoprotein Cholesterol (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

Trial Locations

Locations (89)

China Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China

Fuwai Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China

Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Haidian Hospital; 🇨🇳 Beijing, Beijing, China

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Hospital; 🇨🇳 Beijing, Beijing, China

Chongqing Emergency Medical Center; 🇨🇳 Chongqing, Chongqing, China

Chongqing General Hospital; 🇨🇳 Chongqing, Chongqing, China

Dongguan Songshan Lake Central Hospital; 🇨🇳 Dong Guan, Guangdong, China

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