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NCT02850081 · ClinicalTrials.gov registry record · Phase 3
Statin Neuroprotection and Carotid Endarterectomy: Safety, Feasibility and Outcomes
A Phase 3 study, sponsored by Columbia University.
- Terminated
- Registry status
- Phase 3
- Development phase
- 31
- Enrollment target
NCT02850081: Clinical Trial Phase 3 study, sponsored by Columbia University.
NCT02850081 is a Phase 3 study that was terminated before completion, run by Columbia University. The registered enrollment target is 31 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02850081, a Phase 3 study, was terminated before completion, sponsored by Columbia University.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 31 participants
- Enrollment target
Study Summary
The investigators hypothesize that pre-operative statin use is neuroprotective at maximal doses. The goals are to determine the safety, feasibility, and efficacy of maximizing statin doses for two weeks (12-18 days) prior to CEA using change in performance on a battery neuropsychometric tests as outcome measure. Study will recruit patients based on their preexisting statin regimen. The investigators hypothesize that in asymptomatic CEA patients: 1) Pre-operative statin use is neuroprotective against early cognitive dysfunction (eCD) and lowers the risk of early mortality. 2) Maximal doses may be essential in achieving optimal neuroprotection against eCD.
Primary Outcome
Neurocognitive assessments ≥2SD worse than reference group in two or more cognitive domains or (b) ≥1.5SD worse than the reference group in all cognitive domains. Due to early study termination and limited sample size, the study was not adequately powered to support inferential statistical comparisons. Therefore, outcome data are presented descriptively without formal statistical testing.
Interventions
- OTHER Placebo
- DRUG Statin
- DRUG Atorvastatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2017-06-01 |
| Est. Completion | 2020-03-31 |
| Phase | Phase 3 |
Why NCT02850081 stopped before completion
NCT02850081 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02850081 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02850081 about?
NCT02850081 is a clinical study titled "Statin Neuroprotection and Carotid Endarterectomy: Safety, Feasibility and Outcomes". The investigators hypothesize that pre-operative statin use is neuroprotective at maximal doses. The goals are to determine the safety, feasibility, and efficacy of maximizing statin doses for two weeks (12-18 days) prior to CEA using change in performance on a battery neuropsychometric tests as out...
What is the current status of trial NCT02850081?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 31 participants. The study started on 2017-06-01. Estimated completion is 2020-03-31.
What interventions are being tested in trial NCT02850081?
The interventions under investigation include: Placebo (OTHER), Statin (DRUG), Atorvastatin (DRUG).
Who is sponsoring clinical trial NCT02850081?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02850081's enrollment target sits among peer trials
31 1914th of 2000 higher than 84 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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