Extension trial to evaluate long term safety of patients randomised into 1160.113 RE-ALIGN study (RE-ALIGN-EX)
- Conditions
- anticoagulant therapy in mechanical heartvalves10046973
- Registration Number
- NL-OMON39208
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 25
1. Male and female patients aged over18 and below or equal 75 years at time of inclusion into 1160.113.
2. The patient must be able to give informed consent in accordance with ICH GCP guidelines and local legislation and/or regulations.
3. Continuing need for anticoagulation.
1. Active infective endocarditis.
2. Uncontrolled hypertension (systolic blood pressure (SBP) >180mm Hg and/or diastolic blood pressure (DBP) >100mm Hg) as measured at baseline for this study (Visit 1).
3. Need for continued treatment with ticlopidine, ticagrelor, prasugrel, systemic ketoconazole, itraconazole, cyclosporine, tracrolimus, dronedarone, rifampicin, phenytoin, carbamazepine, St. John*s Wort or any cytotoxic/myelosuppressive therapy. See Section 4.2.2.
4. Recent malignancy or radiation therapy (since inclusion into 1160.113) unless the malignancy was a basal cell carcinoma that was completely removed.
5. Pre-menopausal (last menstruation <=1 year prior to screening) who:
• Are pregnant or nursing or
• Are not surgically sterile or
• Are of child bearing potential and not practising an acceptable method of birth control, or do not plan to continue practising an acceptable method of birth control throughout the trial (highly effective methods of birth control are defined as those, alone or in combination, that result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly [R09-1292].
6. Patients not willing or able to comply with the protocol requirements or considered unreliable by the Investigator concerning the requirements for follow-up during the study and/or compliance with study drug administration, have a life expectancy less than the expected duration of the trial due to concomitant disease or have any condition which, in the opinion of the Investigator, would not allow safe participation in the study (e.g. drug addiction, alcohol abuse).
7. Previous participation in this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>There are no primary or secondary efficacy and safety variables. Clinical<br /><br>efficacy and safety outcome variables, mortality and morbidity endpoints will<br /><br>be evaluated in an exploratory manner and are described in Section 5.3.1.1 and<br /><br>5.3.2.1. other endpoints.</p><br>
- Secondary Outcome Measures
Name Time Method <p>See Sections 5.3.1.1 and 5.3.2.1 of the protocol for other endpoints.</p><br>