Repatha® for Atherosclerotic Cardiovascular Disease
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
Observational Study
Major Cardiovascular EventEstablished Atherosclerotic Cardiovascular Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 150
Sex
Any
Study type
Observational
Participants needed
7,000 (estimated)
Sponsor
Amgen · Industry
Who this trial is looking for
This trial is looking for adults with atherosclerotic cardiovascular disease. Participants will either receive Repatha® along with their usual treatment or just their usual treatment to see how well it prevents heart-related problems.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I can give my consent or have someone authorized to give consent for me.
I have been prescribed Repatha® alongside my existing treatment.
I had a heart attack or stroke in the last 2 years.
I have had multiple heart attacks or strokes in my life.
I have diabetes and had a heart attack or stroke.
I have serious narrowing in multiple heart arteries.
My recent cholesterol levels are high.
You may not be able to join if
I had a stroke in the past month.
I have ever had a hemorrhagic stroke.
I had a stroke caused by a blood clot.
I used Repatha® or similar treatments in the last 6 months.
I am currently in another clinical trial.
I have a severe allergy to Repatha®.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 w…
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.
Trial Locations
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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 acco…
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.
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