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NCT03376893 · ClinicalTrials.gov registry record

Epidemiology of Silent and Overt Strokes in Sickle Cell Disease

A clinical trial of Stroke and Sickle Cell Disease, sponsored by Vanderbilt University Medical Center.

Active
Registry status
102
Enrollment target
4
Study locations

NCT03376893 is a study of Stroke and Sickle Cell Disease that is active but no longer recruiting, run by Vanderbilt University Medical Center. The registered enrollment target is 102 participants, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (99% lower). The trial reports 4 study locations across 3 states.

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The verdict

NCT03376893, a study of Stroke and Sickle Cell Disease, is active but no longer recruiting, sponsored by Vanderbilt University Medical Center.

ACTIVE NOT RECRUITING
Registry status
102 participants
Enrollment target
4
Study locations

Study Summary

Sickle Cell Disease (SCD) is a rare disease occurring in an estimated 100,000 individuals, often poor and underserved, in the US. Silent and overt strokes contribute significantly to morbidity in adults with SCD, resulting in functional impairment, challenges with school and job performance, and premature death. Five NIH-funded randomized controlled trials have identified therapies to prevent silent and overt strokes in children with SCD, including monthly blood transfusion therapy (for preventing initial and recurrent strokes) and hydroxyurea (for preventing initial strokes). Despite the observation that at least 99% of children with SCD in high-income countries reach adulthood, and approximately 60% of adults will experience one or more strokes (\~50% with silent strokes and \~10% with overt strokes), no stroke trials have established therapeutic approaches for adults with SCD. For adults with SCD, inadequate evidence-based guidelines exist for secondary stroke prevention strategies. Applying stroke prevention strategies in children may not be effective for stroke prevention in adults with SCD, particularly given the high rate of co-morbidities. Identifying subgroups of adults with SCD and higher incidence coupled with the contribution of established stroke risk factors in the general population (smoking, diabetes, obesity, renal disease) will provide the requisite data required for the first-ever phase III clinical trials focused on secondary stroke prevention in adults.

Study Locations (4)

Tennessee

  • Vanderbilt University Medical Center - Nashville
  • Vanderbilt University Medical Center - Nashville

Alabama

  • University of Alabama at Birmingham - Birmingham

Missouri

  • Washington University School of Medicine - St Louis

Trial Details

FieldValue
Enrollment Target 102 participants
Start Date 2017-06-02
Est. Completion 2026-12-31

What the Registry Record Tells You About NCT03376893

The ClinicalTrials.gov registry entry for NCT03376893 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 102 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 (99% lower). The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.

The record links to 5 conditions, with Stroke appearing as the primary indexed condition, and to 0 interventions.

NCT03376893 reports 4 study locations spanning 3 distinct geographic areas - top geographies include Tennessee, Alabama, Missouri.

Frequently Asked Questions

What is clinical trial NCT03376893 about?

NCT03376893 is a clinical study titled "Epidemiology of Silent and Overt Strokes in Sickle Cell Disease". Sickle Cell Disease (SCD) is a rare disease occurring in an estimated 100,000 individuals, often poor and underserved, in the US. Silent and overt strokes contribute significantly to morbidity in adults with SCD, resulting in functional impairment, challenges with school and job performance, and pre...

What is the current status of trial NCT03376893?

This trial is currently active not recruiting. The enrollment target is 102 participants. The study started on 2017-06-02. Estimated completion is 2026-12-31.

What conditions does trial NCT03376893 study?

This clinical trial studies the following conditions: Stroke, Sickle Cell Disease, Anemia, Sickle Cell, Sickle Cell Thalassemia, Sickle Cell-Beta0-Thalassemia.

Who is sponsoring clinical trial NCT03376893?

This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03376893 being conducted?

This trial has 4 study locations across Alabama, Missouri, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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