RecruitingPhase 4NCT06526117

Stroke Prevention in Nigeria 2 Trial

Primary Prevention of Stroke in Children With SCD in Sub-Saharan Africa II: A Multicenter, Open-label, Single-arm Type I Hybrid Clinical Trial

Sponsor

Vanderbilt University Medical Center

Enrollment

220 participants

Start Date

Aug 5, 2024

Study Type

INTERVENTIONAL

Conditions

Stroke Sickle Cell Disease

Summary

The primary goal of this study is to complete a multicenter single-arm, type I hybrid trial to assess the effectiveness of hydroxyurea therapy for primary stroke prevention in high-risk children with sickle cell anemia (SCA) living in Nigeria in routine care settings.

Eligibility

Min Age: 5 YearsMax Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Hydroxyurea for people with sickle cell disease and stroke. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 5 Years to 12 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHydroxyurea

The study intervention will include initial treatment with low-dose hydroxyurea therapy at 10 mg/kg/day (range 7 - 15 mg/kg/day), with subsequent increase to moderate dose hydroxyurea therapy at 20 mg/kg/day (range 17.5 - 26 mg/kg/day) after at least two severe events requiring physician contact.