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

January 5, 2012
July 10, 2014
December 2011
June 2013   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT01505881 on ClinicalTrials.gov Archive Site
  • 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

Not Provided
Not Provided
Not Provided
 
Follow on Study From RE-ALIGN
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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Thromboembolism
  • Heart Valve Prosthesis
  • Drug: dabigatran etexilate low dose
    active treatment (low)
  • Drug: warfarin 5mg
    comparator warfarin
  • Drug: dabigatran etexilate intermediate dose
    active treatment (medium)
  • Drug: warfarin 1mg
    comparator warfarin
  • Drug: dabigatran etexilate high dose
    active treatment (high)
  • Drug: warfarin 3mg
    comparator warfarin
  • Experimental: Dabigatran etexilate
    Patient dose determined by dose allocated in 1160.113 and CrCl levels
    Interventions:
    • Drug: dabigatran etexilate low dose
    • Drug: dabigatran etexilate intermediate dose
    • Drug: dabigatran etexilate high dose
  • Active Comparator: warfarin
    warfarin doses to maintain INR levels
    Interventions:
    • Drug: warfarin 5mg
    • Drug: warfarin 1mg
    • Drug: warfarin 3mg
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
158
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   Czech Republic,   Denmark,   France,   Germany,   Netherlands,   Norway,   Poland
 
NCT01505881
1160.138, 2011-002285-21
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP