Overview

Dabigatran Etexilate in Patients With Mechanical Heart Valves

Status:
Terminated

Trial end date:
2013-06-01

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Boehringer Ingelheim

Treatments:

Dabigatran
Warfarin

Criteria

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