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 |
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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