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

NCT01210755 | Completed Phase 4 DMC

• 1 other identifier: DCIC 10 09
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Venous Thromboembolism

Keywords

Antithrombotics; Haemostatics; Antidote

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• In vitro, activated partial thromboplastin time

  just before and 1, 2, 3 and 4 hours after taking medicine

Study Arms (2)

Rivaroxaban then Dabigatran

EXPERIMENTAL

Cross-over study with 15 days between administration of Rivaroxaban and Dabigatran

Drug: Rivaroxaban, Dabigatran

Dabigatran then Rivaroxaban

EXPERIMENTAL

Cross-over study with 15 days between administration of Dabigatran and Rivaroxaban

Drug: Dabigatran; Rivaroxaban

Interventions

Rivaroxaban, Dabigatran DRUG

Rivaroxaban: One dose of 20mg (2 tablets of 10mg) then Dabigatran: One dose of 150mg(2 capsules of 75mg) two weeks later

Also known as: Xarelto, Pradaxa

Rivaroxaban then Dabigatran

Dabigatran; Rivaroxaban DRUG

Dabigatran: One dose of 150mg(2 capsules of 75mg) then Rivaroxaban: One dose of 20mg (2 tablets of 10mg)two weeks later

Also known as: Pradaxa, Xarelto

Dabigatran then Rivaroxaban

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Clinical Research Centre, University Hospital Grenoble

Grenoble, 38043, France

Location

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

Rivaroxaban; Dabigatran

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Gilles Pernod, MD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 27, 2010
• First Posted: September 28, 2010
• Study Start: November 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 1, 2011

Record last verified: 2011-06

Locations

FR (1)