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NCT04219774 · ClinicalTrials.gov registry record · Phase 2
NeuroCognition After Carotid Recanalization
A Phase 2 study of Stroke and Cognition Disorder, sponsored by Duke University.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
- 2
- Study locations
NCT04219774 is a Phase 2 study of Stroke and Cognition Disorder that has completed, run by Duke University. The registered enrollment target is 25 participants, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT04219774, a Phase 2 study of Stroke and Cognition Disorder, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
- 2
- Study locations
Study Summary
Complete occlusion of the Internal carotid artery (ICA) by atherosclerotic disease (COICA) causes approximately 15%-25% of ischemic strokes in the carotid artery distribution. Patients treated with medical therapy have a 7%-10% risk of recurrent stroke per year for any stroke and a 5%-8% risk per year for ipsilateral ischemic stroke during the first 2 years after ICA occlusion. Internal carotid artery occlusion causes an estimated 61,000 first-ever strokes per year in the US an incidence more than twice the annual occurrence of ruptured intracranial aneurysms Additionally, 40% of subjects with COICA who present with transient ischemic attack (TIA) and 70% of COICA who present with stroke have cognitive decline with increased risk of vascular dementia and Alzheimer's' disease (AD) with time (2,3). Symptomatic COICA subjects are at increased risk of developing cognitive impairment and progressive development of vascular dementia and AD with time. Our proposal leverages several compelling retrospective and prospective preliminary data from human to perform this exploratory trial with go/no-go criteria to proceed to a phase 3 based on the data generated
Conditions Studied
Interventions
- PROCEDURE Endovascular intervention
- DRUG Aspirin and Clopidogrel (maximal medical Therapy)
Study Locations (2)
Iowa
- University of Iowa hospitals and Clinics - Iowa City
North Carolina
- Duke University - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2020-05-01 |
| Est. Completion | 2024-03-14 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04219774
The ClinicalTrials.gov registry entry for NCT04219774 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Stroke appearing as the primary indexed condition, and to 2 interventions - of which Endovascular intervention is the first listed.
NCT04219774 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Iowa, North Carolina.
Frequently Asked Questions
What is clinical trial NCT04219774 about?
NCT04219774 is a clinical study titled "NeuroCognition After Carotid Recanalization". Complete occlusion of the Internal carotid artery (ICA) by atherosclerotic disease (COICA) causes approximately 15%-25% of ischemic strokes in the carotid artery distribution. Patients treated with medical therapy have a 7%-10% risk of recurrent stroke per year for any stroke and a 5%-8% risk per ye...
What is the current status of trial NCT04219774?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2020-05-01. Estimated completion is 2024-03-14.
What conditions does trial NCT04219774 study?
This clinical trial studies the following conditions: Stroke, Cognition Disorder, Occlusion Carotid.
What interventions are being tested in trial NCT04219774?
The interventions under investigation include: Endovascular intervention (PROCEDURE), Aspirin and Clopidogrel (maximal medical Therapy) (DRUG).
Who is sponsoring clinical trial NCT04219774?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04219774 being conducted?
This trial has 2 study locations across Iowa, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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