Impact of LDL-cholesterol Lowering on Platelet Activation

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT03331666
Phase
PHASE4
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Evolocumab — DRUG
    140 mg every 14 days A monoclonal antibody designed for the treatment of hyperlipidemia

Study Details

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 acute coronary syndrome (ACS) patients.

Key Dates

Start date
Nov 16, 2018
Status verified
Mar 2021
Primary completion
Feb 4, 2020
Completion
Feb 4, 2020

Study Design

Enrollment
4 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • Active Comparator: Evolocumab
    Subjects will start with placebo and will receive Evolocumab 140 mg every 14 days starting Day 14 until Day 196.
  • Placebo Comparator: Placebo
    Subjects will start with placebo and will receive Evolocumab 140 mg every 14 days starting Day 28 until Day 196.

Primary Outcome Measure

Adenosine Di-phosphate (ADP) Induced, P2Y12 Dependent and Arachidonic Acid Induced Platelet Activation (P2Y12 Reaction Units (PRU)) [ Time Frame: Day 7, Day 14, Day 21, Day 28, Day 84 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Medical CenterNew YorkNew York10032-

Find similar trials in New York, NY

By research site
Columbia University Medical Center· New York, NY

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