Study to Evaluate the Impact of a Targeted Lipid Optimization Program on LDL-C Control in At-risk… (NCT07034690) | Clinical Trial Compass
RecruitingPhase 4
Study to Evaluate the Impact of a Targeted Lipid Optimization Program on LDL-C Control in At-risk Adult Patients With Dyslipidemia
United Arab Emirates326 participantsStarted 2025-11-26
Plain-language 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.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* 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.
Exclusion Criteria:
* 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 d…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of participants achieving target LDL-C goals based on CV risk