Phase IV investigator initiated clinical trial to study the effectiveness of alirocumab, an inhibitor of proprotein convertase subtilisin/kexin (PCSK9), versus placebo added to high-intensity statin (atorvastatin 80 mg) in lowering low density lipoprotein (LDL) cholesterol during non-ST segment elevation myocardial infarction (NSTEMI).
This research will study the effects of early initiation of alirocumab in addition to high intensity statin therapy in patients who have previously been treated with high intensity statins with poor response, who present with a type I (spontaneous) acute NSTEMI. Patients will be dosed with drug or placebo once during the first day of their hospital admission. Blood samples will be collected at baseline, 3 days and 14 days after randomization for biomarker testing. Particular attention will be paid to additional LDL lowering effects, as well as the effects on PCSK9 levels and inflammatory biomarkers. Safety and tolerability will be monitored with complete blood count + differential and complete metabolic panels at each study visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
20
Virginia Commonwealth University
Richmond, Virginia, United States
Changes in Low-density Lipoprotein (LDL) Cholesterol
Placebo-corrected percentage change in calculated LDL cholesterol from baseline to day 14
Time frame: baseline and 14 days
Change in Inflammatory Markers (hsCRP)
Placebo-corrected percentage change in inflammatory markers (hsCRP) from baseline to 3 days
Time frame: baseline to 3 days
Change in Inflammatory Markers (hsCRP)
Placebo-corrected Percentage Change in Inflammatory Markers (hsCRP) From Baseline to 14 Days
Time frame: baseline to 14 days
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