Intend Research | Norman, OK
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About
This study will assess the effect of lowering low-density lipoprotein cholesterol (LDL-C) with evolocumab on major cardiovascular events in adults without a prior myocardial infarction (MI) or stroke who are at high risk of a cardiovascular event.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion criteria:
Age: Adult subjects ≥ 50 (men) or ≥ 55 (women) to ˂ 80 years of age (either sex) and meeting lipid criteria
Low-density lipoprotein cholesterol (LDL-C) ≥ 90 mg/dL (≥ 2.3 mmol/L) or non-high-density lipoprotein cholesterol (non-HDL) ≥ 120 mg/dL (≥ 3.1 mmol/L), or apolipoprotein B ≥ 80 mg/dL (≥ 1.56 µmol/L)
Evidence of at least one of the following at screening (without prior myocardial infarction or stroke):
A. Significant coronary artery disease (CAD) B. Significant atherosclerotic cerebrovascular disease C. Significant peripheral arterial disease D. Diabetes mellitus
At least 1 high-risk feature
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
12,301 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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