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NCT Number: NCT06295679

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

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.

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

  5. Number of Participants Who Experienced Adverse Drug Reactions

    Time frame: Up to 72 months

Study contacts

Contact information is provided by the study sponsor or research team.

Amgen Call Center

CONTACT

[email protected]

866-572-6436

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Mar 6, 2024
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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