A long term follow on study from RE-ALIGN to evaluate safety of dabigatran etexilate in patients with mechanical heart valve.

Conditions: Anticoagulation following mechanical heart valve surgery
MedDRA version: 14.0Level: PTClassification code 10053468Term: Anticoagulant therapySystem Organ Class: 10042613 - Surgical and medical procedures
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2011-002285-21-DK

Lead Sponsor: Boehringer Ingelheim Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 405

Inclusion Criteria

1. Completed study 1160.113 per protocol
2. Continuing need for anticoagulation

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 265
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 140

Exclusion Criteria

1. uncontrolled hypertension
2. severe renal impairment
3. active liver disease
4. increased risk of bleeding

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this trial is to obtain long term safety data regarding the use of dabigatran etexilate in patients having received a mechanical bileaflet heart valve.;Secondary Objective: Noformal secondary objectives;Primary end point(s): 1: There are no primary or secondary efficacy or safety variables for this study<br>;Timepoint(s) of evaluation of this end point: clinical safety and efficacy endpoints will be studied in an exploratory manner only

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): There are no primary or secondary efficacy or safety variables for this study<br>;Timepoint(s) of evaluation of this end point: clinical safety and efficacy endpoints will be studied in an exploratory manner only