Real-world effectiveness and cardiovascular outcomes of PCSK9 inhibitor therapy: a prospective registry study.
Jan Kafol, Zlatko Fras, Marko Novakovic...
https://pubmed.ncbi.nlm.nih.gov/41787544Actively Recruiting
Phase 4
Age: 18Years +
All Genders
ID07581808
PCSK9-DUO Trial: Dual PCSK9 Inhibition With Inclisiran and Alirocumab in Patients With High Cardiovascular Risk in Secondary Prevention
Led by University Medical Centre Ljubljana · Updated on 2026-06-02
60
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of combining two PCSK9 inhibitors, inclisiran and alirocumab, in adults with high cardiovascular risk who cannot tolerate statins. This study focuses on reducing low-density lipoprotein cholesterol (LDL-C) levels because lowering LDL-C is crucial to reduce the risk of cardiovascular events. The trial aims to see if combining these two treatments, which work by different mechanisms, leads to better LDL-C reduction than using either drug alone in patients with atherosclerotic cardiovascular disease in secondary prevention. Participants will be randomly assigned to one of three groups: inclisiran alone, alirocumab alone, or both treatments combined. Inclisiran is given as a subcutaneous injection at the start and after three months. Alirocumab is administered as a subcutaneous injection every four weeks under clinical supervision for nine months. Patients will be followed for nine months with scheduled clinical visits and laboratory tests at baseline, 1, 3, 6, and 9 months to monitor treatment effects and safety. During the study, participants will have regular clinical assessments and blood tests to measure LDL-C levels and other lipid parameters. Researchers will track changes in LDL-C at 3 and 9 months as the main outcome and will also assess the proportion of participants reaching target LDL-C levels and treatment safety, including any side effects. The study will help understand if dual PCSK9 inhibition is a useful approach for managing cholesterol in patients who cannot use statins.
CONDITIONS
Brief Title
Dual PCSK9 Inhibition With Inclisiran and Alirocumab in Secondary Prevention
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years
- Established atherosclerotic cardiovascular disease (secondary prevention), defined by prior cardiovascular events or imaging-confirmed atherosclerosis
- Eligible for PCSK9 inhibitor therapy according to national clinical criteria
- Fasting LDL cholesterol between 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 for at least 4 weeks prior to enrollment
- Able and willing to provide written informed consent
You will not qualify if you...
- Eligibility for PCSK9 inhibitor therapy only based on elevated lipoprotein(a) >1000 mg/L with LDL-C below inclusion threshold
- Prior use of any PCSK9 inhibitor before enrollment
- Planned start or change of lipid-lowering therapy during the study
- Known homozygous familial hypercholesterolemia
- Active liver disease or ALT/AST >3 times the upper limit of normal
- Severe kidney impairment (eGFR <30 mL/min/1.73 m8)
- Active cancer or life expectancy less than 1 year
- Pregnancy, breastfeeding, or women of childbearing potential not using effective contraception
- Known allergy to inclisiran, alirocumab, or their ingredients
- Participation in another interventional trial within 30 days before enrollment
- Any condition that may interfere with study participation or results interpretation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 9 months
Participants receive treatments with inclisiran, alirocumab, or a combination of both to lower LDL cholesterol levels. Inclisiran is administered subcutaneously at baseline and at 3 months. Alirocumab is administered subcutaneously every 4 weeks in a supervised clinical setting for 9 months.
5 visits at baseline, 1 month, 3 months, 6 months, and 9 months
Trial Site Locations
Total: 1 location
1
University Medical Centre Ljubljana
Ljubljana, Slovenia, 1000
Actively Recruiting
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Research Team
Z
Zlatko Fras, MD, PhD
J
Jan Kafol, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
2025 Focused Update of the 2019 ESC/EAS Guidelines for the management of dyslipidaemias.
François Mach, Konstantinos C Koskinas, Jeanine E Roeters van Lennep...
https://pubmed.ncbi.nlm.nih.gov/408782892019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk.
François Mach, Colin Baigent, Alberico L Catapano...
https://pubmed.ncbi.nlm.nih.gov/31504418Efficacy and safety of alirocumab in reducing lipids and cardiovascular events.
Jennifer G Robinson, Michel Farnier, Michel Krempf...
https://pubmed.ncbi.nlm.nih.gov/25773378Inclisiran administration potently and durably lowers LDL-C over an extended-term follow-up: the ORION-8 trial.
R Scott Wright, Frederick J Raal, Wolfgang Koenig...
https://pubmed.ncbi.nlm.nih.gov/38753448Two Phase 3 Trials of Inclisiran in Patients with Elevated LDL Cholesterol.
Kausik K Ray, R Scott Wright, David Kallend...
https://pubmed.ncbi.nlm.nih.gov/32187462