๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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 โฅ70 mg/dl (or \> 1.8 mmol/L) or non-HDL-C โฅ100 mg/dl
* Very high risk: LDL-C โฅ55 mg/dl (or \> 1.4 mmol/L) or non-HDL-C โฅ85 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