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New treatment option for Atherosclerotic Cardiovascular Disease
Official title Study to Evaluate the Impact of a Targeted Lipid Optimization Program on LDL-C Control in At-risk Adult Patients With Dyslipidemia
ClinicalTrials.gov ID: NCT07034690
What this study is testing
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- 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
You likely can't join if
- Any surgical or medical condition, which in the opinion of the Investigator, may place the participant at higher risk from his/her participation in...
- Unwillingness or inability (e.g., physical or cognitive) to comply with study procedures (including adherence to study visits).
- Participation in any other treatment 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
See the full eligibility 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.
- 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...
- Unwillingness or inability (e.g., physical or cognitive) to comply with study procedures (including adherence to study visits).
- Participation in any other treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Abu Dhabi, United Arab Emirates
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Abu Dhabi, United Arab Emirates. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.