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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Major Cardiovascular Event, Established Atherosclerotic Cardiovascular Disease. Basic parameters: 18 years — 150 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
Primary outcome measures
- Time to CV Death, MI, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization, Whichever Occurs First [Time frame: Up to 72 months]
Secondary outcome measures (5)
- Time to CV Death, MI, or Stroke, Whichever Occurs First [Time frame: Up to 72 months]
- Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline [Time frame: Baseline and end of follow-up (up to 72 months)]
- Percent Change in LDL-C From Baseline [Time frame: Baseline and end of follow-up (up to 72 months)]
- Number of Participants Who Experienced Adverse Events [Time frame: Up to 72 months]
- Number of Participants Who Experienced Adverse Drug Reactions [Time frame: Up to 72 months]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 90 centers
- Beijing Anzhen Hospital, Capital Medical University — Beijing
- China Japan Friendship Hospital — Beijing
- Peking University First Hospital — Beijing
- Fuwai Hospital Chinese Academy of Medical Sciences — Beijing
- Beijing Friendship Hospital, Capital Medical University — Beijing
- Beijing Haidian Hospital — Beijing
- Peking University Third Hospital — Beijing
- Beijing Hospital — Beijing
- … and 82 more centers
Identifiers
NCT: NCT06295679 · 20180442