NCT05974345Completed
In Silico Study Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Patients With Established Cardiovascular Disease
In Silico Non Interventional Secondary Use of Data Study Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Patients With Established Cardiovascular Disease
Source: ClinicalTrials.gov · Last updated 8 May 2024
Brief summary (registry, in English)
Study CKJX839B1FR01 in an In silico trial to predict the efficacy of Inclisiran therapy on major adverse cardiovascular events (MACE) and cardiovascular (CV) death in virtual patients with atherosclerotic cardiovascular disease (ASCVD) and elevated LDL-C.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 204691 (actual)
- First submitted
- 26 Jul 2023
- Start date
- 3 Nov 2023
- Primary completion date
- 15 Dec 2023
- Lead sponsor
- Novartis Pharmaceuticals
- NCT number
- NCT05974345
What you commit to
- Study type: Observational
- Participants enrolled: 204691
- From 3 Nov 2023 to the primary completion date, 15 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with acute coronary syndrome, ischemic stroke, peripheral arterial revascularization procedure or amputation due to atherosclerotic disease \<4 weeks prior to the first study visit
Who the study is looking for
- Patients with atherosclerotic CV disease, defined as any of the following
- Previous MI
- Previous ischemic stroke
- Previous symptomatic peripheral arterial disease (PAD) as evidenced by either intermittent claudication with ABI \<0.85, prior peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease
- Fasting LDL-C ≥ 70 mg/dL
- Under stable (≥ 4 weeks) well-tolerated high-intensity statin with or without ezetimibe.
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Rueil-Malmaison | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.