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Report for Clinical Trial NCT03331666

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Impact of LDL-cholesterol Lowering on Platelet Activation

The primary goal is to assess the impact of Evolocumab therapy on platelet function of familial hypercholesterolemia (FH) patients in a randomized, double blind study. Evolocumab is a humanized monoclonal antibody that targets circulating PCSK9, increases hepatic LDL receptor, decreases plasma LDL cholesterol and reduces risk of cardiovascular events. Evolocumab (brand name Rapatha) has been approved by FDA along with diet and maximally tolerated statin therapy in adults with FH or atherosclerotic heart or blood vessel problems, who need additional lowering of LDL cholesterol. The secondary goal is to determine if platelet activation or the response to Evolocumab therapy is modified by rs3184504 polymorphism. The investigators believe that these investigations will complement ongoing studies to demonstrate that Evolocumab reduces athero-thrombotic risk and aid the decision-making as to whether Evolocumab can reduce the atherothrombotic risk in ACS patients.

NCT03331666 Familial Hypercholesterolemia
MeSH:Hyperlipoproteinemia Type II Hypercholesterolemia
HPO:Hypercholesterolemia Increased LDL cholesterol concentration

1 Interventions

Name: Evolocumab

Description: 140 mg every 14 days A monoclonal antibody designed for the treatment of hyperlipidemia
Type: Drug
Group Labels: 2

Evolocumab Placebo


Primary Outcomes

Description: ADP-stimulated platelet aggregation as assessed by the commercially-available VerifyNow P2Y12 assay (Accriva Diagnostics) will be performed. Unit: PRU.

Measure: Change in P2Y12 Reaction Units

Time: Day 7, Day 14, Day 21, Day 28, Day 84, Day 196.

Secondary Outcomes

Description: Platelet activation measured by flow cytometry or commercially-available enzyme-linked immunoassays (ELISAs). Reported as % positive cells (out of 50,000 cells counted) showed a mean reduction ± standard deviation (SD)

Measure: Change in platelet P-selectin level

Time: Day 7, Day 14, Day 21, Day 28, Day 84, Day 196

Purpose: Prevention

Allocation: Randomized

Crossover Assignment


There is one SNP

SNPs


1 rs3184504

The secondary goal is to determine if platelet activation or the response to Evolocumab therapy is modified by rs3184504 polymorphism.



HPO Nodes


HPO: