Dual PCSK9 Inhibition With Inclisiran and Alirocumab in Secondary Prevention (NCT07581808) | Clinical Trial Compass
RecruitingPhase 4
Dual PCSK9 Inhibition With Inclisiran and Alirocumab in Secondary Prevention
Slovenia60 participantsStarted 2026-05-18
Plain-language summary
This study will evaluate the effectiveness and safety of combining two different types of PCSK9 inhibitors, inclisiran and alirocumab, in patients with high cardiovascular risk who are unable to tolerate statins.
Lowering low-density lipoprotein cholesterol (LDL-C) is essential to reduce the risk of cardiovascular events. While PCSK9 inhibitors are effective, many patients treated with a single agent do not reach recommended LDL-C targets, especially those who cannot take statins.
Inclisiran and alirocumab reduce LDL-C through different mechanisms. Inclisiran decreases the production of PCSK9 in the liver, while alirocumab binds circulating PCSK9 in the blood. Combining these therapies may lead to a greater reduction in LDL-C levels.
In this randomized, open-label clinical trial, approximately 60 patients in secondary prevention will be assigned to one of three groups: inclisiran alone, alirocumab alone, or a combination of both treatments. Patients will be followed for 9 months with regular clinical and laboratory assessments.
The main goal of the study is to determine whether combination therapy leads to greater LDL-C reduction compared to each treatment alone. Secondary objectives include assessing the proportion of patients achieving target LDL-C levels and evaluating treatment safety and tolerability.
Who can participate
Age range
18 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:
* Adults aged ≥18 years
* Established atherosclerotic cardiovascular disease (secondary prevention), defined as prior cardiovascular events or imaging-confirmed atherosclerosis (e.g., coronary artery disease on angiography or CT, carotid plaque on ultrasound, or peripheral arterial disease).
* Eligible for PCSK9 inhibitor therapy according to national clinical criteria
* Fasting LDL cholesterol ≥2.5 mmol/L and ≤5.0 mmol/L at screening
* Documented statin intolerance or contraindication to statin therapy
* On stable background lipid-lowering therapy (including ezetimibe if applicable) for at least 4 weeks prior to enrollment
* Able and willing to provide written informed consent
Exclusion Criteria:
* Eligibility for PCSK9 inhibitor therapy solely based on elevated lipoprotein(a) \>1000 mg/L with LDL-C below inclusion threshold
* Prior use of any PCSK9 inhibitor (alirocumab, evolocumab or inclisiran) before enrollment
* Planned initiation or modification of lipid-lowering therapy during the study period
* Known homozygous familial hypercholesterolemia
* Active liver disease or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3× upper limit of normal
* Severe renal impairment (eGFR \<30 mL/min/1.73 m²)
* Active malignancy or life expectancy \<1 year
* Pregnancy, breastfeeding, or women of childbearing potential not using effective contraception
* Known hypersensitivity to inclisiran, alirocumab, or any of their excipients
* Participatio…
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.