Recruiting
Sponsor ID
20180442

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

Sponsor ID
20180442
Clinicaltrials.gov ID
NCT06295679
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

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.

Additional Study Details

Phase
Phase 4
Product
AMG 145
Type
Observational
Masking
N/A
Enrollment
7000
Additional Study Details

Protocol Summary

Primary Outcome Measures

Time to CV Death, MI, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization, Whichever Occurs First

Timeframe: Up to 72 months

Secondary Outcome Measures

Time to CV Death, MI, or Stroke, Whichever Occurs First

Timeframe: Up to 72 months

Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline

Timeframe: Baseline and end of follow-up (up to 72 months)

Percent Change in LDL-C From Baseline

Timeframe: Baseline and end of follow-up (up to 72 months)

Number of Participants Who Experienced Adverse Events

Timeframe: Up to 72 months

Number of Participants Who Experienced Adverse Drug Reactions

Timeframe: Up to 72 months

Locations

Location
Status
Contact Us
Location
The First Affiliated Hospital of Shantou University Medical College
Guangzhou, Guangdong, China, 510280
Status
Recruiting
Location
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Status
Recruiting
Location
The First Peoples Hospital of Yunnan Province
Kunming, Yunnan, China, 650032
Status
Recruiting
Location
Tangshan Gongren Hospital
tangshan city, Hebei, China, 63000
Status
Recruiting
Location
Huaihe Hospital of Henan University
Kaifeng, Henan, China, 475000
Status
Recruiting
Location
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221006
Status
Recruiting
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