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NCT03258281 · ClinicalTrials.gov registry record · Phase 4
Effects of Evolocumab on Platelet Reactivity in Patients With Diabetes Mellitus
A Phase 4 study, sponsored by Inova Health Care Services.
- Terminated
- Registry status
- Phase 4
- Development phase
- 4
- Enrollment target
NCT03258281: Clinical Trial Phase 4 study, sponsored by Inova Health Care Services.
NCT03258281 is a Phase 4 study that was terminated before completion, run by Inova Health Care Services. The registered enrollment target is 4 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03258281, a Phase 4 study, was terminated before completion, sponsored by Inova Health Care Services.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 4 participants
- Enrollment target
Study Summary
Prospective, single center, double-blind, randomized pharmacodynamic experimental study. The study will enroll 150 subjects with ASCVD on optimal statin therapy as per physician and Diabetes Mellitus (DM) undergoing elective Percutaneous Coronary Intervention (PCI). Eligible patients will be randomized for 30 day treatment to either 1) evolocumab 420 mg ; or 2) placebo.
Primary Outcome
Change from baseline in ADP-stimulated P-selectin expression (% Positive Cells) as measured by flow cytometry between treatment groups (420 mg evolocumab treatment and placebo).
Interventions
- DRUG Placebo
- DRUG Evolocumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2018-05-01 |
| Est. Completion | 2019-10-01 |
| Phase | Phase 4 |
Why NCT03258281 stopped before completion
NCT03258281 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03258281 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03258281 about?
NCT03258281 is a clinical study titled "Effects of Evolocumab on Platelet Reactivity in Patients With Diabetes Mellitus". Prospective, single center, double-blind, randomized pharmacodynamic experimental study. The study will enroll 150 subjects with ASCVD on optimal statin therapy as per physician and Diabetes Mellitus (DM) undergoing elective Percutaneous Coronary Intervention (PCI). Eligible patients will be randomi...
What is the current status of trial NCT03258281?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 4 participants. The study started on 2018-05-01. Estimated completion is 2019-10-01.
What interventions are being tested in trial NCT03258281?
The interventions under investigation include: Placebo (DRUG), Evolocumab (DRUG).
Who is sponsoring clinical trial NCT03258281?
This trial is sponsored by Inova Health Care Services, which has 75 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03258281's enrollment target sits among peer trials
4 1994th of 2000 higher than 6 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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