A research study to find out whether a medicine called inclisiran helps to prevent cardiovascular death, heart attacks or strokes in people who already have vascular disease.
- Conditions
- Atherosclerotic cardiovascular disease (ASCVD)MedDRA version: 26.0Level: LLTClassification code 10051615Term: Atherosclerotic cardiovascular diseaseSystem Organ Class: 100000004866Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2021-002006-27-LT
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 16500
- Male or female =40 years of age
- Fasting LDL-C =1.8 mmol/L (70 mg/dL) at the Screening Visit
- 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
- Established CV disease, defined as any of the following:
- Previous myocardial infarction
- Previous ischemic stroke
- 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
Other inclusion criteria are listed in the clinical study protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 9900
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6600
- New York Heart Association (NYHA) class III or IV heart failure at the Statin Optimization Screening Visit (if applicable), Screening Visit, or at the
Baseline Visit (Day1)
- 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
- Pregnant or nursing (lactating) women
- Women of child-bearing potential, unless they are using effective methods of contraception during dosing of study treatment
Other exclusion criteria are listed in the clinical study protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Inclisiran compared to placebo in reducing the risk of 3P-MACE (composite of CV death, non-fatal MI and non-fatal ischemic stroke) in participants with established ASCVD and a LDL-C =1.8 mmol/L (70 mg/dL);Secondary Objective: Inclisiran compared to placebo in reducing the risk of CV death.<br>Inclisiran compared to placebo in reducing the risk of 4P-MACE (composite of CV death, non-fatal MI, non-fatal ischemic stroke and urgent coronary revascularization).<br>Inclisiran compared to placebo in reducing the risk of major adverse limb events (MALE).<br>Inclisiran compared to placebo in reducing the risk of all-cause death.<br>To evaluate the safety and tolerability of inclisiran compared to placebo.;Primary end point(s): Time to the first occurrence of 3P-MACE ;Timepoint(s) of evaluation of this end point: From randomization to the first occurrence of 3P-MACE
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Time to occurrence of CV death.<br>Time to the first occurrence of 4P-MACE.<br>Time to the first occurrence of MALE (including acute lower limb ischemia, lower limb amputation due to ischemia, or urgent lower limb revascularization for ischemia).<br>Time to the occurrence of all-cause death.<br>Number of participants with SAEs.<br>Number of participants with AEs leading to study treatment<br>discontinuation.;Timepoint(s) of evaluation of this end point: From randomization to the occurrence of the secondary endpoint(s)