Impact of Implementation Strategies on Lp(a) Testing in Secondary Care Settings (Lp(a)CCELERATE)

March 27, 2026 updated by: Novartis Pharmaceuticals

Lp(a)CCELERATE: Impact of Implementation Strategies on Lp(a) Testing in Secondary Care Settings

Lipoprotein(a) [Lp(a)] is recognised as an independent, non-modifiable genetic risk factor for cardiovascular (CV) disease. Current guidelines from the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS) recommend that Lp(a) be measured at least once in every adult's lifetime, however routine Lp(a) testing rates remains infrequent.

The aim of this study is to assess the impact of implementation strategies (IStr) designed to increase the adoption of Lp(a) testing in routine practice, ultimately leading to more individuals being tested in secondary care. This, in turn, is expected to result in the identification and enhanced management of Cardiovascular Disease (CVD) risk patients with elevated Lp(a).

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

4500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals

Study Locations

  • Germany
      • Nuremberg, Germany, 90443
        • Recruiting
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

cardiology centers (or equivalent) with low or inconsistent Lp(a) testing in Germany, Italy and the UK

Description

Inclusion Criteria:

Each cluster within this study has a set of inclusion criteria. In addition, to be eligible for inclusion in this study, all the following criteria at the cluster-level must be met:

Inclusion criteria for centers:

  1. Lp(a) testing is available in this center and reimbursed.
  2. Capacity to increase Lp(a) testing in relevant patient groups (according to the defined patient eligibility criteria).
  3. Low and/or inconsistent Lp(a) testing rate(number of eligible patients tested for Lp(a)/number of eligible patients seen) <15%.
  4. Willingness to fulfill research requirements, e.g., repurposing existing clinic data for research etc.
  5. Seeing a defined number of eligible patients per year based on the sample size required for the study.
  6. Availability of local infrastructure and data interoperability.

Inclusion criteria for HCP survey participants:

1. CV specialists or other HCPs managing and accessing CV risk at their respective centers (cardiology units or equivalent).

Electronic records are eligible for assessment in this study if they meet all the following criteria:

  1. ICF and/or ICF waiver will be sought prior to abstraction of electronic patient records.
  2. Patients attending at least one SOC visit during the pre-defined time intervals (12 months prior to index date and 0-6 months, 7-12 months and 13-24 months post-index).

  3. Previous Lp(a) testing:

    1. Patients with an Lp(a) test recorded before the index date will be included in the baseline assessment, which covers the 12 months prior to the index date.
    2. For post-index assessments at 6-, 12- and 24-months after the index date, patients with an Lp(a) test recorded before the index date will be excluded.
  4. Over 18 years of age and qualify for Lp(a) testing according to local practice.

Exclusion Criteria:

Exclusion criteria at center cluster-level includes:

  1. Centers with no access to Lp(a) testing.
  2. Centers where Lp(a) testing is not reimbursed.

Electronic records will not be assessed for:

1. Patients that have undergone Lp(a) testing prior to index date (for the post-index assessment)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Baseline group
all eligible patients included during the 12 months before the implementation of the strategies.
0-12 months group
all eligible patients included in the study during the first 12 months of the implementation of the strategies.
13-24 months group
all eligible patients included in the study between 13-24 months after the implementation of the strategies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with at least one Lp(a) test prescribed at 12 months post-Implementation Strategy (IStr) vs 12 months pre-IStr
Time Frame: 12 months pre-IStr, 12 months post IStr
12 months pre-IStr, 12 months post IStr

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with at least one Lp(a) test prescribed at 6 and 12 months post-IStr compared to 12 months pre-IStr
Time Frame: 12 months pre-IStr to 6 months post and 12 months pre-IStr to 24 months post
12 months pre-IStr to 6 months post and 12 months pre-IStr to 24 months post
Change in proportion of patients with at least one Lp(a) test prescribed 12 months post IStr vs 12 months pre-IStr by pre-defined subgroups of interest
Time Frame: 12 months pre-IStr, 12 months post IStr
Change in proportion of patients with at least one Lp(a) test prescribed 12 months post IStr vs 12 months pre-IStr by pre-defined subgroups of interest (including but not limited to high and very high risk , recent MI; recurrent ASCVD; pre-mature ASCVD)
12 months pre-IStr, 12 months post IStr
Proportion of tested patients with elevated Lp(a) before and after the implementation of IStr
Time Frame: 12 months pre-IStr, 12 months post-IStr
Proportion of tested patients with elevated Lp(a) ≥50, ≥70, ≥90, ≥180 mg/dL or ≥125, ≥150, ≥190, ≥396 nmol/dL
12 months pre-IStr, 12 months post-IStr
Proportion of HCPs indicating feasibility, appropriateness, and acceptability of interventions post-IStr vs pre-IStr
Time Frame: 6 and 12 months post-IStr
6 and 12 months post-IStr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2025

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

March 27, 2026

First Submitted That Met QC Criteria

March 27, 2026

First Posted (Actual)

April 2, 2026

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CTQJ230A12012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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