Ignite Creation Date:
2024-05-06 @ 10:43 AM
Last Modification Date:
2024-10-26 @ 12:34 PM
Study NCT ID:
NCT03331666
Status:
TERMINATED
Last Update Posted:
2021-04-01
First Post:
2017-10-20
Brief Title:
Impact of LDL-cholesterol Lowering on Platelet Activation
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Impact of LDL-cholesterol Lowering on Platelet Activation
Status:
TERMINATED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated Prematurely due to COVID-19
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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 hypercholesterolemiaStatins may show antithrombotic properties
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None