Implementing EAS/ESC Guideline Recommendation on Lp(a) Testing in Routine PracticeLp(a)CCELERATENCT07508007
Impact of Implementation Strategies on Lp(a) Testing in Secondary Care Settings
An observational study of Implementing EAS/ESC Guideline Recommendation on Lp(a) Testing in Routine Practice, run by Novartis Pharmaceuticals at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Implementing EAS/ESC Guideline Recommendation on Lp(a) Testing in Routine Practice
- How many people
- 4,500 participants
- Where
- 1 siteGermany
- Study dates
- 28 Nov 2025to 31 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: cardiology centers (or equivalent) with low or inconsistent Lp(a) testing in Germany, Italy and the UK
Who may be able to join
- 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:
- Lp(a) testing is available in this center and reimbursed.
- Capacity to increase Lp(a) testing in relevant patient groups (according to the defined patient eligibility criteria).
- Low and/or inconsistent Lp(a) testing rate(number of eligible patients tested for Lp(a)/number of eligible patients seen) <15%.
- Willingness to fulfill research requirements, e.g., repurposing existing clinic data for research etc.
- Seeing a defined number of eligible patients per year based on the sample size required for the study.
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- Availability of local infrastructure and data interoperability.
- 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:
- ICF and/or ICF waiver will be sought prior to abstraction of electronic patient records.
- 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).
- Previous Lp(a) testing:
- 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.
- 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.
- Over 18 years of age and qualify for Lp(a) testing according to local practice.
Who cannot join
- Centers with no access to Lp(a) testing.
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
Germany1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Nuremberg, 90443
About this study
Official title: 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).
- Keywords
- Lp(a), Lipoprotein(a), Secondary Care Settings, implementation science, Lp(a) test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with at least one Lp(a) test prescribed at 12 months post-Implementation Strategy (IStr) vs 12 months pre-IStr
Measured: 12 months pre-IStr, 12 months post IStr
Secondary outcomes (4)
Proportion of patients with at least one Lp(a) test prescribed at 6 and 12 months post-IStr compared to 12 months pre-IStr
Measured: 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
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)
Measured: 12 months pre-IStr, 12 months post IStr
Proportion of tested patients with elevated Lp(a) before and after the implementation of IStr
Proportion of tested patients with elevated Lp(a) ≥50, ≥70, ≥90, ≥180 mg/dL or ≥125, ≥150, ≥190, ≥396 nmol/dL
Measured: 12 months pre-IStr, 12 months post-IStr
Proportion of HCPs indicating feasibility, appropriateness, and acceptability of interventions post-IStr vs pre-IStr
Measured: 6 and 12 months post-IStr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start28 Nov 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implementing EAS/ESC Guideline Recommendation on Lp(a) Testing in Routine PracticeStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07508007
- Sponsor's protocol ID
- CTQJ230A12012
- Acronym
- Lp(a)CCELERATE
- Status last verified
- Mar 2026
- First submitted
- 27 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lp(a)CCELERATE: Impact of Implementation Strategies on Lp(a) Testing in Secondary Care Settings
- ClinicalTrials.gov ID
- NCT07508007
- Acronym / sponsor ID
- Lp(a)CCELERATE / CTQJ230A12012
- Keywords
- Lp(a), Lipoprotein(a), Secondary Care Settings, implementation science, Lp(a) test
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,500 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- cardiology centers (or equivalent) with low or inconsistent Lp(a) testing in Germany, Italy and the UK
Key inclusion criteria (15 listed)
- 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:
- Lp(a) testing is available in this center and reimbursed.
- Capacity to increase Lp(a) testing in relevant patient groups (according to the defined patient eligibility criteria).
- Low and/or inconsistent Lp(a) testing rate(number of eligible patients tested for Lp(a)/number of eligible patients seen) <15%.
- Willingness to fulfill research requirements, e.g., repurposing existing clinic data for research etc.
Key exclusion criteria (4 listed)
- Centers with no access to Lp(a) testing.
- Centers where Lp(a) testing is not reimbursed.
- 1. Patients that have undergone Lp(a) testing prior to index date (for the post-index assessment)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
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
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
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 HCPs indicating feasibility, appropriateness, and acceptability of interventions post-IStr vs pre-IStr
Time frame: 6 and 12 months post-IStr
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Implementing EAS/ESC Guideline Recommendation on Lp(a) Testing in Routine Practice, run by Novartis Pharmaceuticals at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.