Overview

Reversibility of Apixaban Anticoagulation With the Four Factor Prothrombin Complex Concentrate Kcentra

Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
Apixaban is an anticoagulant (also known as blood thinner) approved by the Food and Drug Administration (FDA) for reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. It has no reliable method of reversal. Kcentra is an FDA approved drug derived from blood that is used as an antidote to treat people with bleeding associated with taking the well-known anticoagulant warfarin. This is a Phase I, placebo-controlled, single site, open-label, crossover trial to evaluate the reversibility apixaban anticoagulation with Kcentra.
Phase:
Phase 1
Details
Lead Sponsor:
Thomas Jefferson University
Collaborators:
Bristol-Myers Squibb
CSL Behring
Treatments:
Apixaban
Protein C
Protein S
Thrombin