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
- Phase
- Not Applicable
- Intervention
- Repatha® with Standard of Care Exposure
- Conditions
- Not specified
- Sponsor
- Amgen
- Enrollment
- 7000
- Locations
- 178
- Primary Endpoint
- Time to CV Death, MI, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization, Whichever Occurs First
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
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.
Investigators
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.
- •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).
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.
Arms & Interventions
Repatha® with Standard of Care Exposure
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
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.
Outcomes
Primary Outcomes
Time to CV Death, MI, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization, Whichever Occurs First
Time Frame: Up to 72 months
Secondary Outcomes
- 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)