Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

Hyperlipidemia as exemplified by familial hypercholesterolemia is associated with increased platelet activation and an underlying pro-coagulant state. Hyperlipidemia primes platelets and increases platelet activation in response to various agonists. Plasma cholesterol levels appear to have a critical role in modulating platelet activity as hypercholesterolemia increases platelet activation more potently than hypertriglyceridemia. Increased platelet reactivity may contribute to the increased risk of atherothrombosis associated with hypercholesterolemia. Plasma levels of platelet activation markers such as thrombin-antithrombin complex (TAT), soluble P-selectin (sP-selectin), soluble CD40L (sCD40L) or P-selectin exposure at surface of platelets are increased in hypercholesterolemic patients. Increased levels of the platelet activation markers are associated with increased platelet membrane cholesterol content in hypercholesterolemia.Statins may show antithrombotic properties. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03331666
Study type Interventional
Source Columbia University
Contact
Status Terminated
Phase Phase 4
Start date November 16, 2018
Completion date February 4, 2020

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT05284513 - Collaborative Approach to Reach Everyone With Familial Hypercholesterolemia (CARE-FH) N/A
Enrolling by invitation NCT05271305 - Pilot Study for a National Screening for Familial Hypercholesterolemia
Completed NCT02750527 - Pediatric Population Screening for Type 1 Diabetes and Familial Hypercholesterolemia in Lower Saxony, Germany
Not yet recruiting NCT00924339 - Soy Food Intervention Trial N/A
Withdrawn NCT00751608 - Effect of APL180 on Endothelial Function in Familial Hypercholesterolemia Patients Phase 2
Terminated NCT00079846 - Implitapide in Patients With Homozygous Familial Hypercholesterolemia (HoFH) on Maximal Concurrent Lipid-Lowering Therapy Phase 2
Completed NCT02624869 - Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Children With Inherited Elevated Low-density Lipoprotein Cholesterol (Familial Hypercholesterolemia) Phase 3
Recruiting NCT05758779 - The Danish Familial Hypercholesterolemia Organized Coronary Screening Trial N/A
Enrolling by invitation NCT04929457 - Evaluation of a Digiphysical Screening Method to Identify and Diagnose Familial Hypercholesterolemia
Not yet recruiting NCT04455581 - A Study to Determine the Safety, Tolerability, and Efficacy of SHR-1209 in Patients With Familial Hypercholesterolemia Phase 2
Recruiting NCT04101149 - Genetic Causes of Familial Hypercholesterolemia
Completed NCT00943306 - Long Term, Follow-on Study of Lomitapide in Patients With Homozygous Familial Hypercholesterolemia Phase 3
Completed NCT02462655 - Effects of LDL Apheresis System on the Expression of Genes Involved in Lipoprotein Metabolism and Inflammation in Homozygotes for Familial Hypercholesterolemia N/A
Terminated NCT00079859 - Implitapide in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy Phase 2
Recruiting NCT05066932 - Advanced Lipoproptein Profiling and Cardiovascular Risk Stratification in Familial Hypercholesterolemia
Not yet recruiting NCT04958629 - A Prospective Cohort Study on Familial Hypercholesterolemia in Health Examination Population
Completed NCT02709850 - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS ANGPTL3-LRx in Healthy Volunteers With Elevated Triglycerides and Participants With Familial Hypercholesterolemia Phase 1
Active, not recruiting NCT03832985 - Pediatric Reporting of Adult-Onset Genomic Results Early Phase 1
Terminated NCT02013713 - French Observatory of Familial Hypercholesterolemia in Cardiology
Recruiting NCT02009345 - Familial Hypercholesterolemia Canada / Hypercholesterolemie Familiale Canada