A randomized, double-blind, placebo -controlled, multicenter trial, assessing the impact of inclisiran on major adverse cardiovascular events in participants with established cardiovascular disease (VICTORION-2 PREVENT)
- Conditions
- Major Adverse Cardiovascular Events (MACE)1008220610003216
- Registration Number
- NL-OMON56097
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 650
1) Male or female >=40 years of age
2) Fasting LDL-C >=1.8 mmol/L (70 mg/dL) at the Screening Visit
3) At the Screening Visit, participants must be on a stable (>=4 weeks) and
well-tolerated lipid-lowering regimen (including e.g. with or without
Ezetimibe) that must include a high-intensity statin therapy with either
atorvastatin >=40 mg QD or rosuvastatin >=20 mg QD
4) Established CV disease, defined as any of the following: Previous myocardial
infarction, Previous ischemic stroke, Symptomatic peripheral arterial disease
(PAD).
Other inclusion criteria are listed in the clinical study protocol.
1) Acute coronary syndrome, ischemic stroke, peripheral arterial
revascularization procedure or amputation due to atherosclerotic disease <4
weeks prior to the first study visit.
2) Planned or expected cardiac, cerebrovascular or peripheral artery surgery or
coronary re-vascularization within the 6 months after the first study visit.
3) New York Heart Association (NYHA) class III or IV heart failure
4) Active liver disease
5) Previous exposure to inclisiran or any other non-mAb PCSK9-targeted therapy,
either as an investigational or marketed drug within 2 years prior to the first
study visit
6) Pregnant or nursing (lactating) women
Other exclusion criteria are listed in the clinical study protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method