Apixaban in Patients With Sickle Cell Disease

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Vaso-occlusive Crisis, Reduction in Hospitalizations, Sickle Cell Disease

In brief

In patients with SCD, the use of low dose anticoagulation as an outpatient may lead to a significant decrease in morbidity and as a result, decrease healthcare utilization and costs. This study attempts to critically avoid admissions by reducing daily pain scores and pain crisis as an outpatient by use of a novel oral anticoagulant.

Key facts

Study ID

NCT02179177

Run by

Nirmish Shah

People needed

16

Starts

2015-01-01

Expected to finish

2017-09-03

Last updated by the study team

2020-03-11

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• documented HgbSS, SC or HgbS-beta0 thalassemia,
• age ≥18 years old and ≤80,
• seen in outpatient clinic ≥2 times in past year
• seen for an acute care visit (hospitalization, emergency department, or day hospital visit) for pain >2 times in the past year.

You may not qualify if…

• Hospitalization or day hospital visit for pain crisis within the past 2 weeks
• Patients with ≥10 acute care visits within the past year will be excluded
• Creatinine >3.0 mg/dL
• creatinine ≥1.5 mg/dL AND weight ≤60 kg
• chronic use of antiplatelet or anticoagulation medication
• Patients with known vasculopathy or Moya-Moya
• platelet count <100 X 109/L
• AST or ALT >3 times normal
• chronic red blood cell transfusions (scheduled transfusions)
• packed red blood cell transfusion within the past 2 months
• Use of CYP3A4 and P-gp inhibitor medications

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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