drugset / Trial / NCT01478282

Reversal of the Antithrombotic Action of New Oral Anticoagulants

NCT01478282

Non-randomizedCrossoverSingle-blind

Summary

The main goal of this study is to improve safety and efficiency of clinical practice with the new generation of oral anticoagulants. 1. To determine the effect of new oral anticoagulants (dabigatran and rivaroxaban) on platelets and coagulation mechanisms under flow conditions. 2. To evaluate the ability of the concentrates containing coagulation factors (PCCs and FVIIa) to reverse the effects induced by the new anticoagulants. These studies will be carried out ex vivo in blood samples obtained from healthy volunteers undergoing oral anticoagulant therapy at doses of proven efficacy and safety used in previous clinical trials.

Timeline

Start
2012-01
Primary completion
2012-12
Completion
2012-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dabigatran Unknown 150 mg Oral
Comparator Rivaroxaban Other / unclassified 20 mg Oral