Status:
COMPLETED
Study in Healthy Volunteers of the Reversion by Haemostatic Drugs of the Anticoagulant Effect of New Anti-thrombotics
Lead Sponsor:
University Hospital, Grenoble
Conditions:
Venous Thromboembolism
Eligibility:
MALE
18-35 years
Phase:
PHASE4
Brief 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 inves...
Detailed Description
Background and objective: Currently the most widely prescribed long term anticoagulant drugs are anti vitamin K agents (AVK). They should be used with caution because they are drugs that have a narro...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01210755
Start Date
November 1 2010
End Date
June 1 2011
Last Update
July 1 2011
Active Locations (1)
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1
Clinical Research Centre, University Hospital Grenoble
Grenoble, France, 38043