NCT07034690 Study to Evaluate the Impact of a Targeted Lipid Optimization Program on LDL-C Control in At-risk Adult Patients With Dyslipidemia
| NCT ID | NCT07034690 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Novartis Pharmaceuticals |
| Condition | Atherosclerotic Cardiovascular Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 326 participants |
| Start Date | 2025-11-26 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 326 participants in total. It began in 2025-11-26 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 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
Contact & Investigator
Novartis Pharmaceuticals
STUDY DIRECTOR
Novartis Pharmaceuticals
Frequently Asked Questions
Who can join the NCT07034690 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Atherosclerotic Cardiovascular Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07034690 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07034690 currently recruiting?
Yes, NCT07034690 is actively recruiting participants. Contact the research team at novartis.email@novartis.com for enrollment information.
Where is the NCT07034690 trial being conducted?
This trial is being conducted at Abu Dhabi, United Arab Emirates.
Who is sponsoring the NCT07034690 clinical trial?
NCT07034690 is sponsored by Novartis Pharmaceuticals. The principal investigator is Novartis Pharmaceuticals at Novartis Pharmaceuticals. The trial plans to enroll 326 participants.