Impact of LDL-cholesterol Lowering on Platelet Activation
| Status: | Not yet recruiting |
|---|---|
| Conditions: | High Cholesterol |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/19/2018 |
| Start Date: | January 2018 |
| End Date: | June 1, 2020 |
| Contact: | Nan Wang, PhD |
| Email: | nw30@cumc.columbia.edu |
| Phone: | 212-342-1761 |
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.
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.
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.
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.
Inclusion Criteria:
- Subjects who have a clinical diagnosis of familial hypercholesterolemia (FH)
- Subjects who are referred to Dr. Ginsberg's Lipid Practice for treatment with PCSK9
inhibitor
- Subjects with LDL cholesterol levels >100 mg/dl on baseline treatment with statins
and/or ezitimibe
Exclusion Criteria:
- Children under 18 years of age
We found this trial at
1
site
630 W 168th St
New York, New York
New York, New York
212-305-2862
Principal Investigator: Nan Wang, PhD
Phone: 212-342-1761
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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