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NCT03331666 · ClinicalTrials.gov registry record · Phase 4
Impact of LDL-cholesterol Lowering on Platelet Activation
A Phase 4 study, sponsored by Columbia University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 4
- Enrollment target
NCT03331666 is a Phase 4 study that was terminated before completion, run by Columbia University. The registered enrollment target is 4 participants.
The verdict
NCT03331666, a Phase 4 study, was terminated before completion, sponsored by Columbia University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 4 participants
- Enrollment target
Study 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.
Interventions
- DRUG Evolocumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2018-11-16 |
| Est. Completion | 2020-02-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03331666
The ClinicalTrials.gov registry entry for NCT03331666 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Evolocumab is the first listed.
NCT03331666 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03331666 about?
NCT03331666 is a clinical study titled "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 c...
What is the current status of trial NCT03331666?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 4 participants. The study started on 2018-11-16. Estimated completion is 2020-02-04.
What interventions are being tested in trial NCT03331666?
The interventions under investigation include: Evolocumab (DRUG).
Who is sponsoring clinical trial NCT03331666?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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