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Evaluating Repatha® with Standard Care for Heart Disease in Chinese Patients

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

Observational Amgen · NCT06295679

This study is testing if adding Repatha® to regular heart disease treatment can help Chinese patients reduce serious heart problems compared to just standard care alone.

Quick facts

Study typeObservational
Enrollment7000 (estimated)
Ages18 Years to 150 Years
SexAll
SponsorAmgen Industry-sponsored
Locations90 sites (Beijing, Beijing Municipality and 89 other locations)
Trial IDNCT06295679 on ClinicalTrials.gov

What this trial studies

This study assesses the real-world effectiveness of Repatha® when used alongside standard care compared to standard care alone in reducing major cardiovascular events in Chinese patients with established atherosclerotic cardiovascular disease. It focuses on outcomes such as cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, and coronary revascularization. Participants must be adults who have either been prescribed Repatha® or have received standard care treatment prior to enrollment, with specific cardiovascular conditions outlined in the eligibility criteria.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a history of myocardial infarction or stroke, or those with diabetes and cardiovascular disease.

Not a fit: Patients without established atherosclerotic cardiovascular disease or those not meeting the specific cardiovascular history criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the effectiveness of Repatha® in reducing serious cardiovascular events in patients with atherosclerotic cardiovascular disease.

How similar studies have performed: Other studies have shown promising results with similar approaches in evaluating the effectiveness of combination therapies for cardiovascular diseases.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Beijing, Beijing Municipality and 89 other locations

+40 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Major Cardiovascular EventEstablished Atherosclerotic Cardiovascular DiseaseCardiovascular deathMyocardial infarctionStrokeUnstable anginaCoronary revascularizationAtherosclerotic Cardiovascular Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.