drugset / Trial / NCT01210755

Study in Healthy Volunteers of the Reversion by Haemostatic Drugs of the Anticoagulant Effect of New Anti-thrombotics

NCT01210755

Phase 4 Completed 10 enrolled University Hospital, Grenoble
RandomizedCrossoverOpen-labelBasic science

Summary

The purpose of this study is to evaluate whether the effect of the two new anticoagulants, Dabigatran and Rivaroxaban, can be reversed by non-specific and specific inhibitors. For Dabigatran the investigators will test the non-specific inhibitors: prothrombin complex concentrate (PCC), recombinant activated coagulation factor VII, and activated prothrombin-complex (FEIBA). For Rivaroxaban the investigators will test a specific Rivaroxaban decoy (FXa-GLAless). This will be done in a laboratory using blood plasma from healthy male volunteers.

Timeline

Start
2010-11
Primary completion
2011-03
Completion
2011-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Dabigatran Unknown 150 mg
Subject Rivaroxaban Other / unclassified 20 mg