Follow on study from RE-ALIG
- Conditions
- Anticoagulation following mechanical heart valve surgeryTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]MedDRA version: 14.0Level: PTClassification code 10053468Term: Anticoagulant therapySystem Organ Class: 10042613 - Surgical and medical procedures
- Registration Number
- EUCTR2011-002285-21-NL
- Lead Sponsor
- Boehringer Ingelheim bv
- 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: no formal 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