A Multicenter, Cross-sectional Study to Characterize the Distribution of Lipoprotein(a) Levels Among Patients With Documented History of Atherosclerotic Cardiovascular Disease (ASCVD)

Completed

• Conditions: Atherosclerosis; Coronary heart disease; 10013317

• Registration Number: NL-OMON53411
• Lead Sponsor: Amgen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-04-28
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 1500

Inclusion Criteria

101. Subject has provided informed consent prior to initiation of any study
specific activities/procedures.
102. Age 18 to 85 years.
103. History of ASCVD as demonstrated by either:
a) MI (presumed type 1)
And/or
b) PCI (with high-risk features) with at least 1 of the following:
- Age > 65 years
-Diabetes mellitus
- History of ischemic stroke
- History of peripheral arterial disease
- Residual stenosis >= 50%
- Multivessel PCI (ie, >= 2 vessels, including branch arteries)

See section 5.1 of the protocol.

Exclusion Criteria

201. Subjects known to be currently receiving investigational drug in a
clinical study that is anticipated to last > 1 year
202. Known Lp(a) value < 90 mg/dL (if measured in mass) or < 200 nmol/L (if
measured in molar).
203. Subject has a diagnosis of end-stage renal disease or requires dialysis
204. Poorly controlled (glycated hemoglobin [HbA1c] > 10%) diabetes mellitus
(type 1 or type 2).
205. Subject is receiving or has received lipoprotein apheresis to reduce Lp(a)
within 3 months prior to enrollment.
206. Known uncontrolled or recurrent ventricular tachycardia in the past 3
months prior to enrollment.
207. Known malignancy (except non-melanoma skin cancers, cervical in situ
carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma)
within the last 5 years prior to enrollment.
208. Known history or evidence of clinically significant disease (eg,
respiratory, gastrointestinal, or psychiatric disease) or unstable disorder or
biomarker that, in the opinion of the investigator(s), would result in life
expectancy < 5 years.
209. Known hemorrhagic stroke.

See section 5.2 of the protocol.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>-Lp(a) value.<br /><br>-Lp(a) value >= 90 mg/dL or >=200 nmol/L for the subgroup of subjects with known<br /><br>Lp(a) value.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-Lp(a) value.</p><br>