Venous Thromboembolism Clinical Trial
— REVNEWANTICOOfficial title:
Reversion of the Anticoagulant Effect of the New Antithrombotic Agents Anti-Xa and Anti IIa by Specific and Non-specific Haemostatic Drugs,: an Ex-Vivo Study in Healthy Volunteers
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | June 2011 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 35 Years |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
France | Clinical Research Centre, University Hospital Grenoble | Grenoble |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Grenoble |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | In vitro Reversal of anticoagulation | Reversal of anticoagulation by return of thrombin generation time to normal value | just before and 1, 2, 3 and 4 hours after taking medicine | No |
Secondary | In vitro, activated partial thromboplastin time | Thrombin time, activated partial thromboplastin time. Prothrombin time, measurement of anti Xa activity. |
just before and 1, 2, 3 and 4 hours after taking medicine | No |
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