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ClinicalTrials.gov Identifier: NCT01505881
Recruitment Status : Terminated
First Posted : January 9, 2012
Results First Posted : July 11, 2014
Last Update Posted : July 11, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Thromboembolism Heart Valve Prosthesis Drug: dabigatran etexilate low dose Drug: warfarin 5mg Drug: dabigatran etexilate intermediate dose Drug: warfarin 1mg Drug: dabigatran etexilate high dose Drug: warfarin 3mg Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 158 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of the Long Term Safety of the Use of Dabigatran Etexilate in Patients With a Bileaflet Mechanical Heart Valve
Study Start Date : December 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dabigatran etexilate
Patient dose determined by dose allocated in 1160.113 and CrCl levels
 Drug: dabigatran etexilate low dose
active treatment (low)

Drug: dabigatran etexilate intermediate dose
active treatment (medium)

Drug: dabigatran etexilate high dose
active treatment (high)
Active Comparator: warfarin
warfarin doses to maintain INR levels
 Drug: warfarin 5mg
comparator warfarin

Drug: warfarin 1mg
comparator warfarin

Drug: warfarin 3mg
comparator warfarin


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]
    Percentage of patients with Adverse Events. Prespecified clinical outcome events were not recorded as Adverse Events.


Secondary Outcome Measures :
  1. 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) ]

    Percentage of patients with Adverse Events leading to discontinuation of trial drug.

    Prespecified clinical outcome events were not recorded as Adverse Events.


  2. 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) ]
    Percentage of patients with Serious Adverse Events (SAE). Prespecified clinical outcome events were not recorded as Adverse Events.

  3. 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) ]

    Clinical efficacy outcome events presented are:

    Death, Venous thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attack (TIA), Stroke, Systemic embolism and Valve thrombosis



Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01505881


Locations
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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01505881    
Other Study ID Numbers: 1160.138
2011-002285-21 ( EudraCT Number: EudraCT )
First Posted: January 9, 2012    Key Record Dates
Results First Posted: July 11, 2014
Last Update Posted: July 11, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Warfarin
Dabigatran
 Anticoagulants
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action