Non-interventional Study on the Monthly Administration of 300 mg AliRocumab (PRALUENT®) With the 2 ml SYDNEY Auto-injector

Atherosclerotic Cardiovascular Disease Clinical Trial

— MARS  

Official title:

Non-interventional Study on the Monthly Administration of 300 mg AliRocumab (PRALUENT®) With the 2 ml SYDNEY Auto-injector (MARS-NIS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05129241
• Other study ID #: OBS17242
• Secondary ID: U1111-1265-6221
• Status: Completed
• Start date: November 18, 2021
• Est. completion date: February 16, 2023

Study information

• Verified date: March 2023
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Primary objectives:

• To assess the effectiveness of the PRALUENT® 2 ml SYDNEY auto-injector as measured by the lipid-lowering effect of alirocumab after approx. 12 weeks treatment

• To assess the treatment satisfaction, as well as patient adherence and persistence after approximately 12 weeks of treatment with the PRALUENT® 2 ml SYDNEY auto-injector

Secondary objective:

Safety and tolerability

Description:

Study duration per participant is approximately 12 weeks

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: February 16, 2023
• Est. primary completion date: February 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Primary hypercholesterolaemia (heterozygous familial or non-familial) or mixed dyslipidaemia AND confirmed vascular disease(*) AND other regular risk factors(**), OR confirmed familial heterozygous hypercholesterolaemia

• Documented maximum dietary and drug lipid-lowering therapy within the last 12 months

• Inadequate reduction of low-density lipoprotein cholesterol (LDL-C) despite maximum possible dietary and lipid-lowering therapy

• The decision of the treating physician to use the PRALUENT® 2 ml SYDNEY auto-injector regardless of study enrolment

• No previous therapy with a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor OR prior treatment with a PCSK9 inhibitor every 2 weeks (Q2W) or monthly (Q4W)

• Signed Informed Consent Form

(*) Coronary heart disease (CHD), cerebrovascular manifestation, peripheral arterial occlusive disease (PAOD)

(**) For cardiovascular events (e.g. diabetes mellitus, renal function glomerular filtration rate (GFR) < 60 ml/min)

Exclusion Criteria:

• Planned or existing pregnancy, cancer, drug or alcohol abuse, dementia, or general inability to understand the content of the observational study

• Existing treatment by lipid apheresis

• Age < 18 years

• Contraindications to treatment with alirocumab (PRALUENT®) according to the SmPC

• Current participation in a clinical study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerotic Cardiovascular Disease
• Cardiovascular Diseases
• Dyslipidemias
• Hypercholesterolemia

Locations

Country	Name	City	State
Germany	Investigational Site Number	Germany

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute change from baseline to week 12 in low-density lipoprotein cholesterol (LDL-C)		from baseline to week 12
Primary	Percent change from baseline to week 12 in low-density lipoprotein cholesterol (LDL-C)		from baseline to week 12
Primary	Treatment acceptance assessed using the Injection Treatment Acceptance Questionnaire (ITAQ)		week 12
Secondary	Number of patients with adverse events		up to 12 weeks
Secondary	Number of quality defects assessed using product complaints		up to 12 weeks