Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
600 participants
OBSERVATIONAL
2022-04-15
2029-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The study will recruit patients into one single cohort: Inclisiran in combination with other LLTs. The patients will receive Inclisiran therapy as per the approved label and Belgian reimbursement conditions.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Belgian Real Life Non-interventional Study (NIS) on Xarelto in Non-valvular Atrial Fibrillation (AF) Patients Treated for the Prevention of Stroke and Systemic Embolism
NCT01855139
ImproveR International (BI-001-IM)
NCT00290849
TREatment With Beta-blockers After myOcardial Infarction withOut Reduced Ejection fracTion"
NCT03596385
Comparative Study of ALX-0081 Versus GPIIb/IIIa Inhibitor in High Risk Percutaneous Coronary Intervention (PCI) Patients
NCT01020383
Evaluation of 1-Year Clinical Outcomes With Early Inclisiran Initiation in Post-MI Patients
NCT07142265
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
OTHER
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Inclisiran
Patients prescribed inclisiran on top of standard of care lipid-lowering therapy
Inclisiran
There is no treatment allocation. Patients administered inclisiran by prescription will be enrolled. The patients will receive inclisiran therapy as per the approved label and Belgian reimbursement conditions.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Inclisiran
There is no treatment allocation. Patients administered inclisiran by prescription will be enrolled. The patients will receive inclisiran therapy as per the approved label and Belgian reimbursement conditions.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
2. Patients participating in a clinical trial with investigational product.
3. Heterozygous Familial Hypercholesterolemia patients without established Atherosclerotic Cardiovascular Disease.
18 Years
99 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novartis Investigative Site
Turnhout, Antwerpen, Belgium
Novartis Investigative Site
Yvoir, Namur, Belgium
Novartis Investigative Site
Kortrijk, West-Vlaanderen, Belgium
Novartis Investigative Site
Aalst, , Belgium
Novartis Investigative Site
Anderlecht, , Belgium
Novartis Investigative Site
Brasschaat, , Belgium
Novartis Investigative Site
Brussels, , Belgium
Novartis Investigative Site
Edegem, , Belgium
Novartis Investigative Site
Genk, , Belgium
Novartis Investigative Site
Ghent, , Belgium
Novartis Investigative Site
Haine-Saint-Paul, , Belgium
Novartis Investigative Site
Huy, , Belgium
Novartis Investigative Site
Leuven, , Belgium
Novartis Investigative Site
Liège, , Belgium
Novartis Investigative Site
Mechelen, , Belgium
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Novartis Pharmaceuticals
Role: CONTACT
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CKJX839D1BE01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.