Registry for patients with atherosclerotic cardiovascular disease receiving Inclisiran
A Belgian Registry to Evaluate the Real Life Treatment With Inclisiran on Top of Standard of Care Lipid-lowering Therapy in Patients With Atherosclerotic Cardiovascular Disease
This study looks at how well Inclisiran works and how safe it is for people with atherosclerotic cardiovascular disease who are getting routine treatment in Belgium.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Novartis Industry-sponsored |
| Locations | 14 sites (Aalst and 13 other locations) |
| Trial ID | NCT05726838 on ClinicalTrials.gov |
What this trial studies
This observational study collects data on the effectiveness, safety, and adherence of Inclisiran therapy in patients with atherosclerotic cardiovascular disease (ASCVD) in routine clinical practice. Patients will be enrolled over a six-month period and followed for up to 39 months, with both prospective and retrospective data collection methods employed. The study aims to gather insights on patients receiving Inclisiran in combination with lipid-lowering therapies, adhering to approved treatment protocols and reimbursement conditions in Belgium.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with documented ASCVD who meet specific treatment criteria for Inclisiran.
Not a fit: Patients who have previously received Inclisiran or are currently participating in other clinical trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable information on the real-world effectiveness of Inclisiran, potentially improving treatment strategies for patients with ASCVD.
How similar studies have performed: Other studies have shown promising results with similar approaches in assessing real-world effectiveness of cardiovascular treatments, suggesting potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients who are 18 years or older. 2. Patients with Atherosclerotic Cardiovascular Disease (ASCVD) who are eligible for commercially available Leqvio, as defined by the reimbursement criteria: Patients with ASCVD documented by previous coronary heart disease (CHD), cerebrovascular disease or peripheral artery disease (PAD) and LDL-C ≥ 100mg/dL despite a treatment of min 6 weeks with max tolerated statin (unless intolerance or contra-indication) in combination with ezetimibe (unless intolerance or contra-indication). 3. Heterozygous Familial Hypercholesterolemia (HeFH) patients with documented ASCVD who are eligible for commercially available Leqvio. 4. Patients who provide written informed consent to participate in the study. Exclusion Criteria: 1. Patients who have received Inclisiran previously. 2. Patients participating in a clinical trial with investigational product. 3. Heterozygous Familial Hypercholesterolemia patients without established Atherosclerotic Cardiovascular Disease.
Where this trial is running
Aalst and 13 other locations
- Novartis Investigative Site — Aalst, Belgium (Recruiting)
- Novartis Investigative Site — Anderlecht, Belgium (Recruiting)
- Novartis Investigative Site — Brasschaat, Belgium (Recruiting)
- Novartis Investigative Site — Bruxelles, Belgium (Recruiting)
- Novartis Investigative Site — Edegem, Belgium (Recruiting)
- Novartis Investigative Site — Genk, Belgium (Recruiting)
- Novartis Investigative Site — Gent, Belgium (Recruiting)
- Novartis Investigative Site — Haine-saint-Paul, Belgium (Recruiting)
- Novartis Investigative Site — Huy, Belgium (Recruiting)
- Novartis Investigative Site — Kortrijk, Belgium (Recruiting)
- Novartis Investigative Site — Leuven, Belgium (Recruiting)
- Novartis Investigative Site — Liege, Belgium (Recruiting)
- Novartis Investigative Site — Turnhout, Belgium (Recruiting)
- Novartis Investigative Site — Yvoir, Belgium (Recruiting)
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: +41613241111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.