Reversal of the Antithrombotic Action of New Oral Anticoagulants

• Status: Unknown status
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gines Escolar
• Collaborator: Ministry of Health, Spain
• Treatments: Anticoagulants; Dabigatran; Rivaroxaban

Criteria

Inclusion Criteria:

• Healthy volunteers ages from 21 to 60 years

• Approval informed consent

Exclusion Criteria:

• History of hepatic or kidney disease

• Previous history of hemorrhagic or thrombotic disease

• Pregnancy or breast feeding

• Concomitant use of drugs affecting hemostasis

• Use of medications of herbal treatments that could interfere with the pharmacokinetics or pharmacodynamics of the study drug (according to manufacturers label)

• Practice of risky sports (during the study period)

• Blood donation in the previous 3 months