Lipoprotein(a) in Patients With Cardiovascular Disease (CVD)

Not Applicable

Completed

• Conditions: Cardiovascular Disease and Lipoprotein(a)
• Interventions: Diagnostic Test: Blood draw for Lp(a)

• Registration Number: NCT03887520
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

The study is conducted to improve knowledge about the epidemiology of Lipoprotein(a) in patients with established cardiovascular disease (CVD).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-27
• Study First Submitted: 2019-03-21
• Study First Submitted QC: 2019-03-21
• Study First Posted: 2019-03-25
• Primary Completion: 2021-07-30
• Study Completion: 2021-07-30
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-27
• Last Update Posted: 2022-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49001

Inclusion Criteria

• Signed informed consent

• Established CVD defined as one of the following:

  • History of a myocardial infarction (MI) ≥3 months and ≤10 years before the study visit
  • History of ischemic stroke ≥ 3 months and ≤ 10 years before the study visit
  • Symptomatic PAD (intermitted claudication with ankle-brachial index ≤0.90 and/or lower limb amputation or re-vascularization due to lower limb ischemia

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Exclusion Criteria

• Patients currently enrolled in clinical studies with investigational drugs

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cardiovascular disease	Blood draw for Lp(a)	Patients with established Cardiovascular disease

Primary Outcome Measures

Name	Time	Method
Percentage of patients with normal and elevated Lipoprotein(a) (Lp(a)) levels in patients with established Cardiovascular Disease (CVD)	At screening	Prevalence of normal and elevated Lp(a) levels in patients with established CVD

Secondary Outcome Measures

Name	Time	Method
Low-density lipoprotein cholesterol (LDL(C)) values (corrected and uncorrected)	At screening	Evaluate the median and other relevant statistics describing the distribution of LDL-C (corrected and uncorrected) within the normal range and with elevated Lp(a) levels
Lp(a) values by region and country	At screening	Evaluate the median and other relevant statistics describing the distribution of Lp(a) by region and country
Lipoprotein(a) (Lp(a)) values	At screening	Evaluate the median and other relevant statistics describing the distribution of Lp(a) within the normal range and elevated Lp(a) levels

Trial Locations

Locations (1)

Novartis Investigative Site; 🇻🇳 Ho Chi Minh, Vietnam