Follow on Study From RE-ALIGN

Study Overview
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Brief Summary
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To collect additional data relating to safety and indicators of efficacy for patients who have participated in the 1160.113 study.

Official 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

Conditions
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Thromboembolism, Heart Valve Prosthesis

Intervention / Treatment
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* Drug: dabigatran etexilate low dose
* Drug: warfarin 5mg
* Drug: dabigatran etexilate intermediate dose
* Drug: warfarin 1mg
* Drug: dabigatran etexilate high dose
* Drug: warfarin 3mg


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Completed study 1160.113 per protocol Continuing need for anticoagulation Exclusion criteria: uncontrolled hypertension severe renal impairment active liver disease increased risk of bleeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dabigatran etexilate<br>Patient dose determined by dose allocated in 1160.113 and CrCl levels | Drug: dabigatran etexilate low dose<br>* active treatment (low)<br>Drug: dabigatran etexilate intermediate dose<br>* active treatment (medium)<br>Drug: dabigatran etexilate high dose<br>* active treatment (high)<br>|
| Active Comparator: warfarin<br>warfarin doses to maintain INR levels | Drug: warfarin 5mg<br>* comparator warfarin<br>Drug: warfarin 1mg<br>* comparator warfarin<br>Drug: warfarin 3mg<br>* comparator warfarin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) |