Qualified individuals must be male or female, aged 40 or older with established cardiovascular (CV) disease, defined as any of the following:
– Previous myocardial infarction
– Previous ischemic stroke
– Symptomatic peripheral arterial disease (PAD)
At the Screening Visit, participants must also be on a stable and well-tolerated lipid-lowering regimen.
Participants will receive an investigational medication (active study drug) or placebo, via injection. Study medication and study-related assessments will be provided at no cost. Reimbursement for study-related expenses may be provided.
Study participation will last about 3-6 years depending on when participants enter the study. The number of visits to the study centre will vary (4 to 7 times in the first year, and then twice a year thereafter).
The following information is from ClinicalTrials.gov
Last Update Posted: March 26, 2023
NCT05030428
Novartis Pharmaceuticals
Brief Summary:
Study CKJX839B12302 is a pivotal Phase III trial to evaluate the benefits of inclisiran on major adverse cardiovascular (MACE) events in participants with established cardiovascular disease (CVD).
Condition or Disease:
Atherosclerotic Cardiovascular Disease
Intervention/Treatment:
Drug: Inclisiran sodium 300 mgPhase:
Phase 3
Ages Eligible for Study:
40 Years and older (Adult)
Sexes Eligible for Study:
All
Inclusion Criteria:
Fasting LDL-C ≥ 70 mg/dL at randomization visit
Stable (greater than or equal to 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 greater than or equal to 40 mg QD or rosuvastatin greater than or equal to 20 mg QD
Established CV disease defined as ANY of the following three conditions
Spontaneous Myocardial infarction ≥ 4 weeks from screening visit
History of ischemic stroke occurred ≥ 4 weeks prior to the Screening visit
Symptomatic peripheral arterial disease (PAD) evidenced by either intermittent claudication with ankle brachial index (ABI) < 0.85, prior peripheral arterial revascularization procedure, or, amputation due to atherosclerotic disease.
Exclusion Criteria:
Acute coronary syndrome, stroke, peripheral arterial revascularization procedure or amputation due to atherosclerotic disease < 4 weeks before screening visit
Treatment with PCSK9 inhibitors (e.g. evolocumab, alirocumab) within 90 days or planned use post first study visit
Planned or expected cardiac, cerebrovascular or peripheral artery surgery or re-vascularization within the 6 months after the first study visit
Heart failure NYHA class III or IV
Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver
Previous exposure to inclisiran or any other non-mAb PCSK9-targeted therapy, either as an investigational or marketed drug within 2 years
Severe concomitant non-CV disease that is expected to reduce life expectancy to less than 5 years
History of malignancy that required surgery radiation therapy and/or systemic therapy during the 3 years prior to the first study visit
Pregnant or nursing (lactating) women
Other protocol-defined inclusion/exclusion criteria may apply.
Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.
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