Overview

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

Status:
Completed
Trial end date:
2011-06-01
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University Hospital, Grenoble
Treatments:
Anticoagulants
Dabigatran
Hemostatics
Rivaroxaban
Criteria
Inclusion Criteria:

- Male

- Age between 18 and 35 years

- Subject-free any acute or chronic disease

- Subjects who signed the written informed consent

- Subject affiliated to French social security or beneficiary of a similar health
insurance scheme

Exclusion Criteria:

Any subjects with at least one of the following:

- Female

- Body mass index <19 and > 29

- Active or being treated for angina, coronary syndrome, stroke or arterial disease

- Constitutional hemorrhagic disease

- Acquired bleeding disorder

- Presenting or treated for any liver disease

- Abnormal laboratory results for liver function

- History of venous thrombotic disease

- History of heparin induced Thrombocytopenia

- Surgery in the previous month

- Surgery planned within a month

- Creatinine clearance below 60 ml / min

- Clinically significant bleeding or progressive disease at risk of increased bleeding
(congenital or acquired hemorrhagic syndromes, uncontrolled severe hypertension,
evolving gastrointestinal ulcerative disease, recent history of gastrointestinal
ulcer, vascular retinopathy, recent intracranial or intracerebral hemorrhage,
intrathecal or intracerebral vascular anomalies, brain, spinal or ophthalmological
surgery recently)

- Hypersensitivity to the active substance or any excipients

- Person deprived of liberty by judicial or administrative order or person subject to an
order of legal protection

- Refusal of consent