Thromboembolism Clinical Trial
Official title:
Evaluation of the Long Term Safety of the Use of Dabigatran Etexilate in Patients With a Bileaflet Mechanical Heart Valve
To collect additional data relating to safety and indicators of efficacy for patients who have participated in the 1160.113 study.
| Status | Terminated |
| Enrollment | 158 |
| Est. completion date | June 2013 |
| Est. primary completion date | June 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Belgium | 1160.138.32003 Boehringer Ingelheim Investigational Site | Bruxelles | |
| Belgium | 1160.138.32002 Boehringer Ingelheim Investigational Site | Genk | |
| Belgium | 1160.138.32001 Boehringer Ingelheim Investigational Site | Leuven | |
| Canada | 1160.138.11009 Boehringer Ingelheim Investigational Site | Hamilton | Ontario |
| Canada | 1160.138.11011 Boehringer Ingelheim Investigational Site | London | Ontario |
| Canada | 1160.138.11012 Boehringer Ingelheim Investigational Site | Newmarket | Ontario |
| Canada | 1160.138.11001 Boehringer Ingelheim Investigational Site | Saint John | New Brunswick |
| Canada | 1160.138.11007 Boehringer Ingelheim Investigational Site | Toronto | Ontario |
| Czech Republic | 1160.138.42002 Boehringer Ingelheim Investigational Site | Brno | |
| Czech Republic | 1160.138.42003 Boehringer Ingelheim Investigational Site | Olomouc | |
| Czech Republic | 1160.138.42004 Boehringer Ingelheim Investigational Site | Ostrava | |
| Czech Republic | 1160.138.42001 Boehringer Ingelheim Investigational Site | Prague 5 | |
| Denmark | 1160.138.45001 Boehringer Ingelheim Investigational Site | Copenhagen | |
| Denmark | 1160.138.45002 Boehringer Ingelheim Investigational Site | Odense C | |
| France | 1160.138.33004 Boehringer Ingelheim Investigational Site | Bron | |
| France | 1160.138.33001 Boehringer Ingelheim Investigational Site | Paris cedex 18 | |
| France | 1160.138.33002 Boehringer Ingelheim Investigational Site | Pessac | |
| France | 1160.138.33003 Boehringer Ingelheim Investigational Site | Rennes Cedex 2 | |
| Germany | 1160.138.49001 Boehringer Ingelheim Investigational Site | Dresden | |
| Germany | 1160.138.49002 Boehringer Ingelheim Investigational Site | Essen | |
| Germany | 1160.138.49004 Boehringer Ingelheim Investigational Site | Freiburg | |
| Germany | 1160.138.49003 Boehringer Ingelheim Investigational Site | Heidelberg | |
| Germany | 1160.138.49010 Boehringer Ingelheim Investigational Site | Witten | |
| Netherlands | 1160.138.31002 Boehringer Ingelheim Investigational Site | Amsterdam | |
| Netherlands | 1160.138.31004 Boehringer Ingelheim Investigational Site | Breda | |
| Norway | 1160.138.47002 Boehringer Ingelheim Investigational Site | Bergen | |
| Norway | 1160.138.47001 Boehringer Ingelheim Investigational Site | Oslo | |
| Poland | 1160.138.48004 Boehringer Ingelheim Investigational Site | Gdansk | |
| Poland | 1160.138.48003 Boehringer Ingelheim Investigational Site | Warszawa | |
| Poland | 1160.138.48001 Boehringer Ingelheim Investigational Site | Wroclaw |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
Belgium, Canada, Czech Republic, Denmark, France, Germany, Netherlands, Norway, Poland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Patients With Any Adverse Event (AE) | Percentage of patients with Adverse Events. Prespecified clinical outcome events were not recorded as Adverse Events. | From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days) | No |
| Secondary | Percentage of Patients With AEs Leading to Discontinuation of Trial Drug | Percentage of patients with Adverse Events leading to discontinuation of trial drug. Prespecified clinical outcome events were not recorded as Adverse Events. |
From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days) | No |
| Secondary | Percentage of Patients With Serious AEs | Percentage of patients with Serious Adverse Events (SAE). Prespecified clinical outcome events were not recorded as Adverse Events. | From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days) | No |
| Secondary | Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis. | Clinical efficacy outcome events presented are: Death, Venous thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attack (TIA), Stroke, Systemic embolism and Valve thrombosis |
From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days) | Yes |
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