Lipoprotein(a) in Patients With Cardiovascular Disease (CVD) | NCT03887520

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

NCT03887520

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Jan 28, 2022Actual

Enrollment

49,001Actual

Phase

Not Applicable

Conditions

Cardiovascular Disease and Lipoprotein(a)

Interventions

Blood draw for Lp(a)

Countries

United States
Argentina
Australia
Austria
Belgium
Brazil
Bulgaria
Canada
Chile
China
Colombia
Czechia
Denmark
Egypt
France
Germany
Greece
Guatemala
Hong Kong
Hungary
Iceland
India
Israel
Italy
Japan
Lebanon
Malaysia
Mexico
Netherlands
Norway
Peru
Philippines
Poland
Portugal
Puerto Rico
Romania
Russia
Slovakia
Slovenia
South Africa
South Korea
Spain
Sweden
Switzerland
Taiwan
Thailand
Turkey (Türkiye)
United Kingdom
Vietnam

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2018-003786-34	EudraCT Number

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 27, 2018Actual

Primary Completion Date

Jul 30, 2021Actual

Completion Date

Jul 30, 2021Actual

First Submitted Date

Mar 21, 2019

First Submission Date that Met QC Criteria

Mar 21, 2019

First Posted Date

Mar 25, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2022

Last Update Posted Date

Jan 28, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

49,001Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cardiovascular disease	Other	Patients with established Cardiovascular disease	Diagnostic Test: Blood draw for Lp(a)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood draw for Lp(a)	Diagnostic Test	Collect sample for Lipoprotein(a) testing	Cardiovascular disease

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Lipoprotein(a) (Lp(a)) values	Evaluate the median and other relevant statistics describing the distribution of Lp(a) within the normal range and elevated Lp(a) levels	At screening
Lp(a) values by region and country

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Exclusion Criteria:

- Patients currently enrolled in clinical studies with investigational drugs

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Andalusia	Alabama	36420	United States
Novartis Investigative Site

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

Intervention Model Description

This is a multi-center cross-sectional epidemiological study to estimate the prevalence (%) of patients with elevated Lp(a) in patients with established CVD defined by their medical history. One study visit is planned for data collection. Relevant medical history and laboratory values for LDL-cholesterol (LDL-C) and Lp(a) within a past pre-specified period will be collected retrospectively. In case laboratory data are not available, blood sampling will be performed.

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D011677	Punctures
D013514	Surgical Procedures, Operative
D008919	Investigative Techniques