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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01505881 |
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Date of registration:
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05/01/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Follow on Study From RE-ALIGN
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Scientific title:
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Evaluation of the Long Term Safety of the Use of Dabigatran Etexilate in Patients With a Bileaflet Mechanical Heart Valve |
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Date of first enrolment:
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December 2011 |
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Target sample size:
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158 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01505881 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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Belgium
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Canada
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Czech Republic
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Denmark
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France
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Germany
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Netherlands
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Norway
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Poland
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Sweden
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United States
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Contacts
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Name:
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Boehringer Ingelheim |
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Address:
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Telephone:
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Email:
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Affiliation:
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Boehringer Ingelheim |
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Completed study 1160.113 per protocol
2. Continuing need for anticoagulation
Exclusion criteria:
1. uncontrolled hypertension
2. severe renal impairment
3. active liver disease
4. increased risk of bleeding
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Thromboembolism
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Heart Valve Prosthesis
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Intervention(s)
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Drug: warfarin 3mg
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Drug: warfarin 5mg
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Drug: dabigatran etexilate low dose
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Drug: warfarin 1mg
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Drug: dabigatran etexilate high dose
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Drug: dabigatran etexilate intermediate dose
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Primary Outcome(s)
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Percentage of Patients With Any Adverse Event (AE)
[Time Frame: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)]
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Secondary Outcome(s)
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Percentage of Patients With AEs Leading to Discontinuation of Trial Drug
[Time Frame: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)]
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Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis.
[Time Frame: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)]
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Percentage of Patients With Serious AEs
[Time Frame: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)]
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Secondary ID(s)
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1160.138
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2011-002285-21
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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