Sickle Cell Anemia Clinical Trial
Official title:
The Effect of Factor Xa Inhibition, With Rivaroxaban, on the Pathology of Sickle Cell Disease
The primary study hypothesis is that inhibition of factor Xa with rivaroxaban will reduce
inflammation, coagulation and endothelial cell activation, and improve microvascular blood
flow in patients with sickle cell disease (SCD) during the non-crisis, steady state. To test
this hypothesis, this study will evaluate the effects of rivaroxaban on:
- plasma markers of inflammation;
- plasma markers of endothelial activation;
- plasma markers of thrombin generation; and
- microvascular blood flow assessed using laser Doppler velocimetry (LDV) of
post-occlusive reactive hyperemia (PORH).
In a cross-over design, subjects will receive rivaroxaban 20 mg/day and placebo for 4 weeks
each, separated by a 2-week washout phase.
The study will consist of a Screening Phase, two Treatment Phases, a Wash-Out Phase, and a
Follow-up Phase. The Screening Phase will occur within 28 days of randomization and will
include informed consent, a physical examination, and complete medical history to include
determination of sickle cell genotype and current medications. Clinical laboratory tests to
be performed include: a Complete Blood Count (CBC) with differential and reticulocyte count;
Prothrombin time(PT) / activated partial thromboplastin time (aPTT); and serum chemistries
(BUN, creatinine, total and direct bilirubin, alanine aminotransferase (ALT), aspartate
aminotransferase (AST), alkaline phosphatase, and LDH). A chest x-ray and MRI/MRA of the
brain will also be done at Screening to rule out underlying disease.
If the patient is found through the screening process to be eligible, the 1st Treatment Phase
begins. Baseline safety assessments and measurement of biomarkers are completed, then the
subject is randomized to receive rivaroxaban or placebo. After 4 weeks of treatment, there is
a 2-Week Wash-Out Phase. After the Wash-Out Phase, another set of baseline studies are
performed and the 2nd Treatment Phase begins. For this Phase of the study, the subject
"crosses over" to receive whatever treatment - rivaroxaban or placebo - that they did not
receive in the 1st Treatment Phase. After taking the assigned study drug for 4 weeks, the 2nd
Treatment Phase ends. The subject returns 2 weeks after the last dose of study treatment for
the Follow-Up Phase, consisting of a single end-of-study visit during which safety
assessments are repeated.
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