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Follow on Study From RE-ALIGN

Primary Purpose

Thromboembolism, Heart Valve Prosthesis

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
dabigatran etexilate low dose
warfarin 5mg
dabigatran etexilate intermediate dose
warfarin 1mg
dabigatran etexilate high dose
warfarin 3mg
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Thromboembolism

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 1160.138.32003 Boehringer Ingelheim Investigational Site
  • 1160.138.32002 Boehringer Ingelheim Investigational Site
  • 1160.138.32001 Boehringer Ingelheim Investigational Site
  • 1160.138.11001 Boehringer Ingelheim Investigational Site
  • 1160.138.11009 Boehringer Ingelheim Investigational Site
  • 1160.138.11011 Boehringer Ingelheim Investigational Site
  • 1160.138.11012 Boehringer Ingelheim Investigational Site
  • 1160.138.11007 Boehringer Ingelheim Investigational Site
  • 1160.138.42002 Boehringer Ingelheim Investigational Site
  • 1160.138.42003 Boehringer Ingelheim Investigational Site
  • 1160.138.42004 Boehringer Ingelheim Investigational Site
  • 1160.138.42001 Boehringer Ingelheim Investigational Site
  • 1160.138.45001 Boehringer Ingelheim Investigational Site
  • 1160.138.45002 Boehringer Ingelheim Investigational Site
  • 1160.138.33004 Boehringer Ingelheim Investigational Site
  • 1160.138.33001 Boehringer Ingelheim Investigational Site
  • 1160.138.33002 Boehringer Ingelheim Investigational Site
  • 1160.138.33003 Boehringer Ingelheim Investigational Site
  • 1160.138.49001 Boehringer Ingelheim Investigational Site
  • 1160.138.49002 Boehringer Ingelheim Investigational Site
  • 1160.138.49004 Boehringer Ingelheim Investigational Site
  • 1160.138.49003 Boehringer Ingelheim Investigational Site
  • 1160.138.49010 Boehringer Ingelheim Investigational Site
  • 1160.138.31002 Boehringer Ingelheim Investigational Site
  • 1160.138.31004 Boehringer Ingelheim Investigational Site
  • 1160.138.47002 Boehringer Ingelheim Investigational Site
  • 1160.138.47001 Boehringer Ingelheim Investigational Site
  • 1160.138.48004 Boehringer Ingelheim Investigational Site
  • 1160.138.48003 Boehringer Ingelheim Investigational Site
  • 1160.138.48001 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dabigatran etexilate

warfarin

Arm Description

Patient dose determined by dose allocated in 1160.113 and CrCl levels

warfarin doses to maintain INR levels

Outcomes

Primary Outcome Measures

Percentage of Patients With Any Adverse Event (AE)
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
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
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.
Clinical efficacy outcome events presented are: Death, Venous thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attack (TIA), Stroke, Systemic embolism and Valve thrombosis

Full Information

First Posted
January 5, 2012
Last Updated
July 10, 2014
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT01505881
Brief Title
Follow on Study From RE-ALIGN
Official Title
Evaluation of the Long Term Safety of the Use of Dabigatran Etexilate in Patients With a Bileaflet Mechanical Heart Valve
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Terminated
Study Start Date
December 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thromboembolism, Heart Valve Prosthesis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dabigatran etexilate
Arm Type
Experimental
Arm Description
Patient dose determined by dose allocated in 1160.113 and CrCl levels
Arm Title
warfarin
Arm Type
Active Comparator
Arm Description
warfarin doses to maintain INR levels
Intervention Type
Drug
Intervention Name(s)
dabigatran etexilate low dose
Intervention Description
active treatment (low)
Intervention Type
Drug
Intervention Name(s)
warfarin 5mg
Intervention Description
comparator warfarin
Intervention Type
Drug
Intervention Name(s)
dabigatran etexilate intermediate dose
Intervention Description
active treatment (medium)
Intervention Type
Drug
Intervention Name(s)
warfarin 1mg
Intervention Description
comparator warfarin
Intervention Type
Drug
Intervention Name(s)
dabigatran etexilate high dose
Intervention Description
active treatment (high)
Intervention Type
Drug
Intervention Name(s)
warfarin 3mg
Intervention Description
comparator warfarin
Primary Outcome Measure Information:
Title
Percentage of Patients With Any Adverse Event (AE)
Description
Percentage of patients with Adverse Events. Prespecified clinical outcome events were not recorded as Adverse Events.
Time Frame
From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
Secondary Outcome Measure Information:
Title
Percentage of Patients With AEs Leading to Discontinuation of Trial Drug
Description
Percentage of patients with Adverse Events leading to discontinuation of trial drug. Prespecified clinical outcome events were not recorded as Adverse Events.
Time Frame
From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
Title
Percentage of Patients With Serious AEs
Description
Percentage of patients with Serious Adverse Events (SAE). Prespecified clinical outcome events were not recorded as Adverse Events.
Time Frame
From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
Title
Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis.
Description
Clinical efficacy outcome events presented are: Death, Venous thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attack (TIA), Stroke, 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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1160.138.32003 Boehringer Ingelheim Investigational Site
City
Bruxelles
Country
Belgium
Facility Name
1160.138.32002 Boehringer Ingelheim Investigational Site
City
Genk
Country
Belgium
Facility Name
1160.138.32001 Boehringer Ingelheim Investigational Site
City
Leuven
Country
Belgium
Facility Name
1160.138.11001 Boehringer Ingelheim Investigational Site
City
Saint John
State/Province
New Brunswick
Country
Canada
Facility Name
1160.138.11009 Boehringer Ingelheim Investigational Site
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
1160.138.11011 Boehringer Ingelheim Investigational Site
City
London
State/Province
Ontario
Country
Canada
Facility Name
1160.138.11012 Boehringer Ingelheim Investigational Site
City
Newmarket
State/Province
Ontario
Country
Canada
Facility Name
1160.138.11007 Boehringer Ingelheim Investigational Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
1160.138.42002 Boehringer Ingelheim Investigational Site
City
Brno
Country
Czech Republic
Facility Name
1160.138.42003 Boehringer Ingelheim Investigational Site
City
Olomouc
Country
Czech Republic
Facility Name
1160.138.42004 Boehringer Ingelheim Investigational Site
City
Ostrava
Country
Czech Republic
Facility Name
1160.138.42001 Boehringer Ingelheim Investigational Site
City
Prague 5
Country
Czech Republic
Facility Name
1160.138.45001 Boehringer Ingelheim Investigational Site
City
Copenhagen
Country
Denmark
Facility Name
1160.138.45002 Boehringer Ingelheim Investigational Site
City
Odense C
Country
Denmark
Facility Name
1160.138.33004 Boehringer Ingelheim Investigational Site
City
Bron
Country
France
Facility Name
1160.138.33001 Boehringer Ingelheim Investigational Site
City
Paris cedex 18
Country
France
Facility Name
1160.138.33002 Boehringer Ingelheim Investigational Site
City
Pessac
Country
France
Facility Name
1160.138.33003 Boehringer Ingelheim Investigational Site
City
Rennes Cedex 2
Country
France
Facility Name
1160.138.49001 Boehringer Ingelheim Investigational Site
City
Dresden
Country
Germany
Facility Name
1160.138.49002 Boehringer Ingelheim Investigational Site
City
Essen
Country
Germany
Facility Name
1160.138.49004 Boehringer Ingelheim Investigational Site
City
Freiburg
Country
Germany
Facility Name
1160.138.49003 Boehringer Ingelheim Investigational Site
City
Heidelberg
Country
Germany
Facility Name
1160.138.49010 Boehringer Ingelheim Investigational Site
City
Witten
Country
Germany
Facility Name
1160.138.31002 Boehringer Ingelheim Investigational Site
City
Amsterdam
Country
Netherlands
Facility Name
1160.138.31004 Boehringer Ingelheim Investigational Site
City
Breda
Country
Netherlands
Facility Name
1160.138.47002 Boehringer Ingelheim Investigational Site
City
Bergen
Country
Norway
Facility Name
1160.138.47001 Boehringer Ingelheim Investigational Site
City
Oslo
Country
Norway
Facility Name
1160.138.48004 Boehringer Ingelheim Investigational Site
City
Gdansk
Country
Poland
Facility Name
1160.138.48003 Boehringer Ingelheim Investigational Site
City
Warszawa
Country
Poland
Facility Name
1160.138.48001 Boehringer Ingelheim Investigational Site
City
Wroclaw
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
23991661
Citation
Eikelboom JW, Connolly SJ, Brueckmann M, Granger CB, Kappetein AP, Mack MJ, Blatchford J, Devenny K, Friedman J, Guiver K, Harper R, Khder Y, Lobmeyer MT, Maas H, Voigt JU, Simoons ML, Van de Werf F; RE-ALIGN Investigators. Dabigatran versus warfarin in patients with mechanical heart valves. N Engl J Med. 2013 Sep 26;369(13):1206-14. doi: 10.1056/NEJMoa1300615. Epub 2013 Aug 31.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1160/1160.138_Statement.pdf
Description
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