A Cross-sectional Study of Lipoprotein(a) Levels in Patients With Documented History of Atherosclerotic Cardiovascular Disease (ASCVD)

Not Applicable

Completed

• Conditions: Atherosclerotic Cardiovascular Disease

• Registration Number: NCT05378529
• Lead Sponsor: Amgen

Brief Summary

The purpose of this study is to characterize the distribution of lipoprotein(a) (Lp(a)) levels among participants with a history of ASCVD as defined by their medical history and is 2-fold:

* Evaluate the distribution of Lp(a) value in the overall participants with documented history of ASCVD

* Evaluate the distribution of Lp(a) value in participants with documented history of ASCVD by demographics and regions

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-19
• Study First Submitted: 2022-05-02
• Study First Submitted QC: 2022-05-12
• Study First Posted: 2022-05-18
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39480

Inclusion Criteria

• Signed informed consent
• History of ASCVD

Exclusion Criteria

• Participants known to be currently receiving investigational drug in a clinical study
• Participants with a diagnosis of end-stage renal disease or requiring dialysis
• Participants who have received lipoprotein apheresis to reduce Lp(a) within 3 months prior to enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of participants with elevated Lp(a) with documented history of ASCVD	Up to approximately 2 weeks

Secondary Outcome Measures

Name	Time	Method
Lp(a) Levels	Up to approximately 2 weeks	Blood sampling will be performed in cases where Lp(a) values are not available at enrollment. In cases where Lp(a) values are available, data will be collected retrospectively.
Lp(a) Levels stratified by demographics and region	Up to approximately 2 weeks

Trial Locations

Locations (725)

St Pauls Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Pedicor Trial sro; 🇨🇿 Ostrava-Dubina, Czechia

Charite - Campus Benjamin Franklin; 🇩🇪 Berlin, Germany

Klinikiniai sprendimai; 🇱🇹 Kaunas, Lithuania

Kardiologijos ir reabilitacijos klinika; 🇱🇹 Klaipeda, Lithuania

Scientia Investigacion Clinica SC; 🇲🇽 Chihuahua, Mexico

D and A Research and Genetics; 🇳🇱 Sneek, Netherlands

cmi Cardiologie - Dr Mercea Corina Delia; 🇷🇴 Baia Mare, Romania

Spitalul Universitar de Urgenta Militar Central Dr Carol Davila; 🇷🇴 Bucuresti, Romania

Ascension Saint Vincents Birmingham; 🇺🇸 Birmingham, Alabama, United States

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