Follow on Study From RE-ALIGN

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01505881
First received: January 5, 2012
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention 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 Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    Percentage of patients with Adverse Events. Prespecified clinical outcome events were not recorded as Adverse Events.


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

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

    Prespecified clinical outcome events were not recorded as Adverse Events.


  • 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) ] [ Designated as safety issue: No ]
    Percentage of patients with Serious Adverse Events (SAE). Prespecified clinical outcome events were not recorded as Adverse Events.

  • 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) ] [ Designated as safety issue: Yes ]

    Clinical efficacy outcome events presented are:

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



Enrollment: 158
Study Start Date: December 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01505881

Locations
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, Belgium
Canada, New Brunswick
1160.138.11001 Boehringer Ingelheim Investigational Site
Saint John, New Brunswick, Canada
Canada, Ontario
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
1160.138.11007 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
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, Czech Republic
Denmark
1160.138.45001 Boehringer Ingelheim Investigational Site
Copenhagen, Denmark
1160.138.45002 Boehringer Ingelheim Investigational Site
Odense C, Denmark
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, France
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, Germany
Netherlands
1160.138.31002 Boehringer Ingelheim Investigational Site
Amsterdam, Netherlands
1160.138.31004 Boehringer Ingelheim Investigational Site
Breda, Netherlands
Norway
1160.138.47002 Boehringer Ingelheim Investigational Site
Bergen, Norway
1160.138.47001 Boehringer Ingelheim Investigational Site
Oslo, Norway
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, Poland
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01505881     History of Changes
Other Study ID Numbers: 1160.138, 2011-002285-21
Study First Received: January 5, 2012
Results First Received: June 6, 2014
Last Updated: July 10, 2014
Health Authority: Belgium:
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: Central Committee Research Involving Human Subjects
Norway: Norwegian Medicines Agency
Poland: Registration Medicinal Product Medical Device Biocidal Product
United States: Food and Drug Administration

Additional relevant MeSH terms:
Thromboembolism
Cardiovascular Diseases
Embolism and Thrombosis
Thrombosis
Vascular Diseases
Dabigatran
Warfarin
Anticoagulants
Antithrombins
Enzyme Inhibitors
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Serine Proteinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014