Status:
COMPLETED
In Silico Study Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Patients With Established Cardiovascular Disease
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Atherosclerotic Cardiovascular Disease
Eligibility:
All Genders
18-99 years
Brief Summary
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 atheroscler...
Detailed Description
Purpose of this study is to predict the size of efficacy of inclisiran 300 mg s.c., administered on Day 1, Month 3 (Day 90), and every 6 months thereafter in addition to currently available lipid lowe...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- Patients with atherosclerotic CV disease, defined as any of the following
- i. Previous MI
- ii. Previous ischemic stroke
- iii. 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.
- Exclusion Criteria :
- 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
Exclusion
Key Trial Info
Start Date :
November 3 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 15 2023
Estimated Enrollment :
204691 Patients enrolled
Trial Details
Trial ID
NCT05974345
Start Date
November 3 2023
End Date
December 15 2023
Last Update
May 8 2024
Active Locations (1)
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1
Novartis Investigative Site
Rueil-Malmaison, France, 92563