Recruiting patients (≥40 but <80 years of age) at high cardiovascular risk, to participate in a clinical trial. Must be at an increased risk for a first
MACE – Major Adverse Cardiovascular Event (i.e. no prior major ASCVD – Atherosclerotic Cardiovascular Disease event), defined as any one of
the following:
a. evidence of atherosclerotic CAD – Coronary Artery Disease on CT – Computer Tomography or invasive coronary angiogram
b. coronary artery calcium (CAC) score obtained by CT-scan ≥100 Agatston units
c. high 10-year ASCVD – Atherosclerotic Cardiovascular Disease risk ≥20%
d. intermediate 10-year ASCVD risk 7.5% – <20% with at least 2 risk- enhancing factors (to be reviewed during screening)
Individuals must maintain a stable dose (if on a background LLT – Lipid-Lowering Therapy) for at least 4 weeks prior to the screening visit, and
be willing to remain on this background therapy for the duration of the study. LDL-C – Low Density Lipoprotein Cholesterol ≥70 mg/dL (≥1.81
mmol/L) but <190 mg/dL (<4.91 mmol/L) at the screening visit, is also required.
Participants will receive investigational treatment (active study drug) or placebo, via subcutaneous injection. Study treatment and study-related
assessments will be provided. Reimbursement for study-related expenses may be provided.
Study participation will last about 3-5 years and involve about 16 visits to the study centre, plus a safety follow-up call.
Peterborough - Kawartha Cardiology Clinical Trials
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Last Update Posted: September 24, 2023
NCT05739383
Novartis Pharmaceuticals
Brief Summary:
CKJX839D12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligram (mg) subcutaneous (s.c.) administered on Day 1, Day 90, and every 6 months thereafter in patients at high cardiovascular (CV) risk without a prior major atherosclerotic cardiovascular disease (ASCVD) event will significantly reduce the risk of 4-Point-Major Adverse Cardiovascular Events (4P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI), non-fatal ischemic stroke, and urgent coronary revascularization, compared to placebo.
Condition or Disease:
Primary Prevention of Atherosclerotic Cardiovascular Disease
Intervention/Treatment:
Drug: Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mLPhase:
Phase 3
Ages Eligible for Study:
40 Years and 79 Years (Adult)
Sexes Eligible for Study:
All
Inclusion Criteria:
At an increased risk for a first MACE (i.e., no prior major ASCVD event), defined as any one of the following:
Evidence of atherosclerotic coronary artery disease (CAD) on computer tomography (CT) or invasive coronary angiogram defined as a coronary artery stenosis ≥20% but <50% in the left main coronary artery or stenosis ≥20% but <70% in any major epicardial coronary artery, or Coronary artery calcium (CAC) score obtained by CT-scan ≥100 Agatston units, or High 10-year ASCVD risk ≥20%, or Intermediate 10-year ASCVD risk 7.5% - <20% with at least 2 risk-enhancing factors. If on a background lipid lowering therapy, the dose should be stable for at least 4 weeks prior to the screening visit and the participant should be willing to remain on this background therapy for the entire duration of the study. LDL-C ≥70 mg/dL (≥1.81 mmol/L) but <190 mg/dL (<4.91 mmol/L) at the screening visit. Exclusion Criteria: History of major ASCVD event. History of, or planned, ischemia-driven revascularization in a coronary or extracoronary arterial bed prior to randomization Absence of coronary atherosclerosis on a CT angiogram or an invasive coronary angiogram in the 2 years prior to randomization Coronary artery calcium (CAC) score of 0 obtained in the 2 years prior to randomization Active liver disease or hepatic dysfunction Previous, current, or planned treatment with a monoclonal antibody (mAb) directed toward proprotein convertase subtilisin/kexin type 9 (PCSK9) (e.g., evolocumab, alirocumab) Pregnant or nursing (lactating) women Women of childbearing potential unless they are using effective methods of contraception while taking study treatment Other protocol-defined inclusion/exclusion criteria may apply.
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