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

A Multicenter, Cross-sectional Study to Characterize the Distribution of Lipoprotein(a) Levels Among Patients With Documented History of Atherosclerotic Cardiovascular Disease (ASCVD) - 20210057

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON53411
Enrollment
1500
Registered
2022-07-28
Start date
2022-08-04
Completion date
Unknown
Last updated
2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis Coronary heart disease

Interventions

None listed

Sponsors

Amgen
Lead Sponsor

Eligibility

Inclusion criteria

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

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 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

Design outcomes

Primary

MeasureTime frame
-Lp(a) value. -Lp(a) value >= 90 mg/dL or >=200 nmol/L for the subgroup of subjects with known Lp(a) value.

Secondary

MeasureTime frame
-Lp(a) value.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)