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NeuroCognition After Carotid Recanalization
NCT04219774 · View on ClinicalTrials.gov ↗
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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,129 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04219774 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Iowa, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04219774?
The interventions under investigation include: Endovascular intervention (PROCEDURE), Aspirin and Clopidogrel (maximal medical Therapy) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04219774?
This trial is sponsored by Duke University, which has 1,129 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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