Atherosclerotic Cardiovascular DiseasePhase 4OPTIMANCT07034690
Study to Evaluate the Impact of a Targeted Lipid Optimization Program on LDL-C Control in At-risk Adult Patients With Dyslipidemia
A Phase 4 study testing Educational Material in people with Atherosclerotic Cardiovascular Disease, run by Novartis Pharmaceuticals at 1 site in United Arab Emirates.
Trial summary
This study is an open label, randomized, prospective, type I hybrid effectiveness- implementation, pragmatic clinical trial to evaluate the impact of a targeted lipid optimization program on LDL-C control in participants with dyslipidemia who are at high risk or very high risk of cardiovascular events. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease
- What is being tested?
- Educational Material
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 26 Nov 2025to 31 May 2028
- Phase
- Phase 4
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of ASCVD (coronary heart disease, peripheral arterial disease and/or cerebrovascular disease)
- High risk or very high risk for cardiovascular events (as per the 2019 ESC/EAS guidelines [1] for the management of dyslipidemias)
- Lipid levels:
- High risk: LDL-C ≥70 mg/dl (or > 1.8 mmol/L) or non-HDL-C ≥100 mg/dl
- Very high risk: LDL-C ≥55 mg/dl (or > 1.4 mmol/L) or non-HDL-C ≥85 mg/dl
- Male or Female
Show all 11Show fewer
- 18 years or older
- Seen by a specialist who is prescribing advanced lipid lowering treatments (LLTs) (cardiologist, endocrinologist or any other relevant specialist)
- Currently taking maximum-tolerated statins
- Ability to participate in educational program (must be able to watch online videos)
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Who cannot join
- Any surgical or medical condition, which in the opinion of the Investigator, may place the participant at higher risk from his/her participation in the study, or is likely to prevent the participant from complying with the requirements of the study or completing the study.
- Unwillingness or inability (e.g., physical or cognitive) to comply with study procedures (including adherence to study visits).
- Participation in any other interventional study.
- Inability to travel to study sites for in-person clinic visits.
- Responsible physician clinical decision not to engage the identified patient.
- Refusal of the potential participant to sign the consent and be included in the model.
- Other protocol-defined inclusion/exclusion criteria may apply
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
United Arab Emirates1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Abu Dhabi
About this study
Official title: A Prospective, Type I Hybrid Effectiveness-implementation, Open Label, Randomized Study to Evaluate the Impact of a Targeted Lipid Optimization Program on LDL-C Control in at- Risk Adult Patients From Abu Dhabi, United Arab Emirates (UAE) With Dyslipidemia
This study is an open label, randomized, prospective, type I hybrid effectiveness- implementation, pragmatic clinical trial to evaluate the impact of a targeted lipid optimization program on LDL-C control in participants with dyslipidemia who are at high risk or very high risk of cardiovascular events.
Read the detailed description
The treatment of interest is a lipid optimization program in the form of a health education intervention delivered via clinic visits (every 4 months) and virtual sessions (between each clinic visit).
No active drug treatment will be provided. The intervention in this study will involve the implementation of a lipid optimization, education program for patients at high risk and very high risk of cardiovascular events.
- Conditions
- Atherosclerotic Cardiovascular Disease
- Being tested
- Educational Material, Standard of care
- Keywords
- Dyslipidemia,, ASCVD,, lipid optimization program,, LDL-C target,, educational intervention,, hybrid effectiveness-implementation study
- Medical subject headings
- Atherosclerosis, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational MaterialOther
Health Education Intervention delivered via clinic visits (every 4 months) and virtual sessions (between each clinic visit)
Standard of careOther
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Other | Participants receive Health Education Intervention alongside standard of care Receives: Other: Educational Material; Other: Standard of care |
| Control Group | Other | Participants receive Standard of care Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants achieving target LDL-C goals based on CV risk
Percentage of participants achieving target Low-Density Lipoprotein Cholesterol (LDL-C) goals based on Cardiovascular (CV) risk stratified by group:
- Very high risk: <55 mg/dl
- High risk: <70 mg/dl
Measured: Baseline, month 12
Secondary outcomes (14)
Percentage of participants achieving or maintaining target LDL-C goals based on CV risk
Percentage of participants achieving or maintaining target Low-Density Lipoprotein Cholesterol (LDL-C) goals based on Cardiovascular (CV) risk stratified by group:
- Very high risk: <55 mg/dl
- High risk: <70 mg/dl
Measured: Baseline, month 24
Change of LDL-C
Change of Low-Density Lipoprotein Cholesterol (LDL-C) from baseline at 12 months and 24 months in both study groups
Measured: Baseline, month 12 and month 24
Change in the proportion of participants receiving advanced lipid lowering therapies
Change in the proportion of participants receiving advanced lipid lowering therapies at 12 months and 24 months from baseline, for each group
Measured: Month 12 and Month 24
Proportion of participants from the intervention group who complete all visits
Proportion of participants from the intervention group who complete all:
- In clinic visits
- Virtual sessions
Measured: 24 months
Proportion of participants from the intervention group who discontinue the education program
Proportion of participants from the intervention group who discontinue the education program before the 12 month study visit
Measured: 12 months
Proportion of days covered
Proportion of days covered (for statins and non-statin lipid therapies)
Measured: Baseline, month 12 and month 24
Number of hospitalizations
Number of hospitalizations during the 12 month active intervention period and the 12 month follow up period
Measured: 24 months
Number of outpatient visits
Number of outpatient visits during the 12 month active intervention period and the 12 month follow up period
Measured: 24 months
Number of ER visits
Number of Emergency Room (ER) visits during the 12 month active intervention period and the 12 month follow up period
Measured: 24 months
Associated costs
Associated costs during the 12 month active intervention period and the 12 month follow up period
Measured: 24 months
Number of LDL-C tests performed
Number of Low-Density Lipoprotein Cholesterol (LDL-C) tests performed, analyzed according to:
- Site (clinic)
- Healthcare Professional (HCP) specialty (Cardiologists, Endocrinologists, internist, etc.)
- Baseline characteristics (e.g. age, sex, ethnicity, Cardiovascular risk status)
Measured: 24 months
Change in knowledge awareness scores:
Awareness regarding lipid management amongst those participants in the intervention group will be measured using a knowledge awareness questionnaire. The same questionnaire will be administered at baseline, 12 months and 24 months, enabling scores to be compared across the study duration.
The knowledge awareness questionnaire scale has a minimum score of 0 and maximum score of 17 points. A high score will indicate higher participant awareness.
Measured: Baseline, month 12 and month 24
Change in WHO BREF quality of life scores
WHO BREF questionnaire assesses QoL across four main domains: physical health, psychological health, social relationships, and environmental health.
Participants will respond to each item using a Likert scale (ranging from 1 to 5) indicating their level of agreement or satisfaction. Higher scores typically indicate better QoL.
Measured: Baseline, month 12 and month 24
Qualitative surveys among focus groups of HCPs and participants to evaluate implementation outcomes
Implementability of the lipid optimization program will be assessed during focus group sessions that explore satisfaction, costs, and acceptance of the program from the perspective of HCPs and participants
Measured: month 12 and month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start26 Nov 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Cardiovascular DiseaseStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 326 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
- NCT07034690
- Sponsor's protocol ID
- CKJX839A1AE02
- Acronym
- OPTIMA
- Status last verified
- Apr 2026
- First submitted
- 16 Jun 2025
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Type I Hybrid Effectiveness-implementation, Open Label, Randomized Study to Evaluate the Impact of a Targeted Lipid Optimization Program on LDL-C Control in at- Risk Adult Patients From Abu Dhabi, United Arab Emirates (UAE) With Dyslipidemia
- ClinicalTrials.gov ID
- NCT07034690
- Acronym / sponsor ID
- OPTIMA / CKJX839A1AE02
- Conditions
- Atherosclerotic Cardiovascular Disease
- Keywords
- Dyslipidemia,, ASCVD,, lipid optimization program,, LDL-C target,, educational intervention,, hybrid effectiveness-implementation study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 326 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 26 Nov 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 24 Jun 2025 (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.
This study is an open label, randomized, prospective, type I hybrid effectiveness- implementation, pragmatic clinical trial to evaluate the impact of a targeted lipid optimization program on LDL-C control in participants with dyslipidemia who are at high risk or very high risk of cardiovascular events.
Detailed description
The treatment of interest is a lipid optimization program in the form of a health education intervention delivered via clinic visits (every 4 months) and virtual sessions (between each clinic visit).
No active drug treatment will be provided. The intervention in this study will involve the implementation of a lipid optimization, education program for patients at high risk and very high risk of cardiovascular events.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Other | Other: Educational Material, Other: Standard of careParticipants receive Health Education Intervention alongside standard of care |
| Control Group | Other | Other: Standard of careParticipants receive Standard of care |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Diagnosis of ASCVD (coronary heart disease, peripheral arterial disease and/or cerebrovascular disease)
- High risk or very high risk for cardiovascular events (as per the 2019 ESC/EAS guidelines [1] for the management of dyslipidemias)
- Lipid levels:
- Male or Female
- 18 years or older
Key exclusion criteria (7 listed)
- Any surgical or medical condition, which in the opinion of the Investigator, may place the participant at higher risk from his/her participation in the study, or is likely to prevent the participant from complying with the requirements of the study or completing the study.
- Unwillingness or inability (e.g., physical or cognitive) to comply with study procedures (including adherence to study visits).
- Participation in any other interventional study.
- Inability to travel to study sites for in-person clinic visits.
- Responsible physician clinical decision not to engage the identified patient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational MaterialHealth Education Intervention delivered via clinic visits (every 4 months) and virtual sessions (between each clinic visit) | Other | Intervention group |
| Standard of careStandard of care | Other | Control Group, Intervention group |
Primary outcome
Percentage of participants achieving target LDL-C goals based on CV risk
Time frame: Baseline, month 12
Percentage of participants achieving target Low-Density Lipoprotein Cholesterol (LDL-C) goals based on Cardiovascular (CV) risk stratified by group: * Very high risk: <55 mg/dl * High risk: <70 mg/dl
14 secondary outcomes
Percentage of participants achieving or maintaining target LDL-C goals based on CV risk
Time frame: Baseline, month 24
Change of LDL-C
Time frame: Baseline, month 12 and month 24
Change in the proportion of participants receiving advanced lipid lowering therapies
Time frame: Month 12 and Month 24
Proportion of participants from the intervention group who complete all visits
Time frame: 24 months
Proportion of participants from the intervention group who discontinue the education program
Time frame: 12 months
Proportion of days covered
Time frame: Baseline, month 12 and month 24
Number of hospitalizations
Time frame: 24 months
Number of outpatient visits
Time frame: 24 months
Number of ER visits
Time frame: 24 months
Associated costs
Time frame: 24 months
Number of LDL-C tests performed
Time frame: 24 months
Change in knowledge awareness scores:
Time frame: Baseline, month 12 and month 24
Change in WHO BREF quality of life scores
Time frame: Baseline, month 12 and month 24
Qualitative surveys among focus groups of HCPs and participants to evaluate implementation outcomes
Time frame: month 12 and month 24
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 4 May 2026.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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?
A Phase 4 study testing Educational Material in people with Atherosclerotic Cardiovascular Disease, run by Novartis Pharmaceuticals at 1 site in United Arab Emirates.
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 11 inclusion and 7 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 4 May 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 United Arab Emirates. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Percentage of participants achieving target LDL-C goals based on CV risk (time frame: Baseline, month 12). 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 4 May 2026.