What is this trial studying about high cardiovascular risk?

This trial is studying whether combining two PCSK9 inhibitors, inclisiran and alirocumab, can better reduce LDL cholesterol in patients with high cardiovascular risk who cannot take statins. The research aims to find out if using both treatments together lowers cholesterol more effectively than either one alone. The University Medical Centre Ljubljana is leading this trial to improve cholesterol management in these patients.

Who may be eligible for this high cardiovascular risk clinical trial?

Adults aged 18 or older with established atherosclerotic cardiovascular disease and statin intolerance may be eligible. Participants must have LDL cholesterol between 2.5 and 5.0 mmol/L and be eligible for PCSK9 inhibitor therapy. The trial accepts all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this high cardiovascular risk clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, participants may have personal travel or other expenses that are not guaranteed to be covered. Participants should plan accordingly for any such costs.

Actively Recruiting

Phase 4

Age: 18Years +

All Genders

ID07581808

Study of Combining Inclisiran and Alirocumab for High-Risk Patients with Heart Disease Who Cannot Take Statins

Led by University Medical Centre Ljubljana · Updated on 2026-06-02

Participants Needed

Research Sites

4 weeks

Total Duration

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

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