anticoagulant therapy in mechanical heartvalves
Conditions
Interventions
Patients will have successfully completed 1160.113 prior to inclusion into this
study. Patients will remain on the treatment arm to which they were randomised
in RE-ALIGN and receive either warfarin
Sponsors
Boehringer Ingelheim
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| There are no primary or secondary efficacy and safety variables. Clinical efficacy and safety outcome variables, mortality and morbidity endpoints will be evaluated in an exploratory manner and are described in Section 5.3.1.1 and 5.3.2.1. other endpoints. | — |
Secondary
| Measure | Time frame |
|---|---|
| See Sections 5.3.1.1 and 5.3.2.1 of the protocol for other endpoints. | — |
Countries
Netherlands
Outcome results
None listed