Dabigatran Etexilate in Patients With Mechanical Heart Valves



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:11/11/2012
Start Date:October 2011
Contact:Boehringer Ingelheim Call Center
Email:clintriage.rdg@boehringer-ingelheim.com
Phone:1-800-243-0127

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A Randomised, Phase II Study to Evaluate the sAfety and Pharmacokinetics of oraL dabIGatran Etexilate in Patients After Heart Valve replacemeNt


To validate the dosing algorithm for dabigatran etexilate in patients receiving a mechanical
heart valve.


Inclusion criteria:

1. Patients aged 18-75

2. Patients who have received a bileaflet mechanical heart valve

Exclusion criteria:

1. Prior valve surgery

2. Uncontrolled hypertension

3. severe renal impairment

4. active liver disease

5. increased risk of bleeding
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