Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03096288 · ClinicalTrials.gov registry record · Phase 4
Impact of Evolocumab on the Effects of Clopidogrel in Patients With High On-Treatment Platelet Reactivity
A Phase 4 study of Atherosclerotic Cardiovascular Disease, sponsored by University of Florida.
- Completed
- Registry status
- Phase 4
- Development phase
- 259
- Enrollment target
- 1
- Study location
NCT03096288 is a Phase 4 study of Atherosclerotic Cardiovascular Disease that has completed, run by University of Florida. The registered enrollment target is 259 participants, below the 7,555-participant average among 21 other Atherosclerotic Cardiovascular Disease trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03096288, a Phase 4 study of Atherosclerotic Cardiovascular Disease, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 259 participants
- Enrollment target
- 1
- Study location
Study Summary
Clopidogrel is the most widely used P2Y12 receptor inhibitor and is the only agent of this class currently recommended in patients with stable coronary artery disease (CAD) undergoing PCI, and for the treatment of stroke or PAD. Pharmacodynamic (PD) studies have shown that approximately 30-40% of patients experience high on-treatment platelet reactivity (HPR) while receiving clopidogrel treatment. Importantly HPR status has been strongly associated with an increased risk of ischemic events. Multiple approaches have been advocated to reduce HPR rates. In a previous study treatment with high-dose atorvastatin in addition to double-dose clopidogrel reduced platelet reactivity significantly more than double-dose clopidogrel alone in statin-naïve patients with stable CAD and HPR. To date, the exact biological mechanisms involved in the statin modulation of platelet function are not fully understood, although likely attributed to both its lipid-lowering and non-lipid-related effects. Evolocumab is a monoclonal antibody targeting proprotein convertase subtilisin/kexin type 9 (PCSK9). The use of evolocumab plus standard therapy, as compared with standard therapy alone, significantly reduced the incidence of cardiovascular events. Whether the reduction in cardiovascular events is simply due to LDL reduction or might be related to other mechanisms is currently subject of investigation. Although LDL reduction with statin therapies has been associated with reduction in platelet reactivity, to date the effects on platelet aggregation of adjunctive lipid lowering with evolocumab has not been explored. The aim of the present study is to investigate the effects of evolocumab in addition to statin therapy on HPR rates and platelet reactivity in patients with atherosclerotic cardiovascular disease (ASCVD) and HPR while on clopidogrel treatment.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Evolocumab
Study Locations (1)
Florida
- University of Florida - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 259 participants |
| Start Date | 2017-10-03 |
| Est. Completion | 2020-11-02 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03096288
The ClinicalTrials.gov registry entry for NCT03096288 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 259 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 7,555-participant average among 21 other Atherosclerotic Cardiovascular Disease trials with a reported enrollment target (97% lower). The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Atherosclerotic Cardiovascular Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03096288 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT03096288 about?
NCT03096288 is a clinical study titled "Impact of Evolocumab on the Effects of Clopidogrel in Patients With High On-Treatment Platelet Reactivity". Clopidogrel is the most widely used P2Y12 receptor inhibitor and is the only agent of this class currently recommended in patients with stable coronary artery disease (CAD) undergoing PCI, and for the treatment of stroke or PAD. Pharmacodynamic (PD) studies have shown that approximately 30-40% of pa...
What is the current status of trial NCT03096288?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 259 participants. The study started on 2017-10-03. Estimated completion is 2020-11-02.
What conditions does trial NCT03096288 study?
This clinical trial studies the following conditions: Atherosclerotic Cardiovascular Disease.
What interventions are being tested in trial NCT03096288?
The interventions under investigation include: Placebo (OTHER), Evolocumab (DRUG).
Who is sponsoring clinical trial NCT03096288?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03096288 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Atherosclerotic Cardiovascular Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
VictORION-INCLUSION: Evaluating Inclisiran for Cholesterol Managment in Heart Disease
ACTIVE NOT RECRUITING · Phase 4
-
A Pragmatic INitiative for LDL-C Management by a CLinical Pharmacist-Led Team Among Atherosclerotic CardiovascUlar DisEase Patients
RECRUITING · NA
-
The Prevent Coronary Artery Disease Trial
RECRUITING · Phase 3
-
Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity
RECRUITING · Phase 3
-
Polygenic Risk Score Implementation and Stratification for Managing Blood Pressure
RECRUITING · NA
-
Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis
RECRUITING · Phase 2
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.