Apixaban in Patients With Sickle Cell Disease

• Status: Terminated
• Trial end date: 2017-09-03
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nirmish Shah
• Collaborator: Bristol-Myers Squibb
• Treatments: Apixaban

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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