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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.
EU CTIS ID: 2024-510735-21-00
What this study is testing
Demonstrate the superiority of 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).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- Mauritius
- Russian Federation
- Philippines
- Kenya
- Malaysia
- Thailand
- Mexico
- Chile
- New Zealand
- Singapore
- Colombia
- India
- Israel
- Canada
- Brazil
- China
- Argentina
- South Africa
- United States
+ 5 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; Mauritius; Russian Federation; Philippines; Kenya; Malaysia and 19 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.