Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long Term Prevention of Recurrent Symptomatic VTE


Tracking Information

Start Date  ICMJENovember 2007
Estimated Primary Completion DateAugust 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: June 18, 2008)		The primary efficacy objective is to evaluate whether dabigatran etexilate is superior to placebo in the long term prevention of recurrent symptomatic (VTE) in patients with DVT or PE who completed 6 to 18 months of treatment with VKA [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE 
 (submitted: November 13, 2007)		The primary efficacy objective is to evaluate whether dabigatran etexilate is superior to placebo in the long term prevention of recurrent symptomatic (VTE) in patients with DVT or PE who completed 6 to 18 months of treatment with VKA
Change HistoryComplete list of historical versions of study NCT00558259 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: June 18, 2008)		Composite of recurrent symptomatic VTE (defined PE excl unexplained death), bleeds, adverse events (AEs), laboratory measures, Acute Coronary Syndromes, EQ 5D and vital signs [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: November 13, 2007)		Composite of recurrent symptomatic VTE (defined PE excl unexplained death), bleeds, adverse events (AEs), laboratory measures, Acute Coronary Syndromes, EQ 5D and vital signs

Descriptive Information

Brief Title  ICMJETwice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long Term Prevention of Recurrent Symptomatic VTE
Official Title  ICMJETwice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long-term Prevention of Recurrent Symptomatic Proximal Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis or Pulmonary Embolism.
Brief Summary

The primary efficacy objective is to evaluate whether dabigatran etexilate is superior to placebo in the long-term prevention of recurrent symptomatic venous thrombo-embolism (VTE) in patients with symptomatic deep-vein thrombosis (DVT) or pulmonary embolism (PE) who completed 6 to 18 months of treatment with vitamin K antagonist (VKA).

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJEPrevention, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEVenous Thromboembolism
Intervention  ICMJE
  • Drug: dabigatran etexilate
  • Drug: placebo

Recruitment Information

Estimated Enrollment  ICMJE1462
Completion Date 
Estimated Primary Completion DateAugust 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients with confirmed symptomatic PE or proximal DVT of the leg(s) who have been treated for 6 to 18 months with therapeutic dosages (intended INR between 2-3) of an oral VKA (e.g. warfarin, acenocoumarol, phenprocoumon, or fluindione) or RE-COVER study medication up to the moment of screening for the current study.
  2. Written informed consent

Exclusion Criteria:

  1. Younger then 18 years of age
  2. Indication for VKA other than DVT and/or PE
  3. Patients in whom anticoagulant treatment for their index PE or DVT should be continued
  4. Active liver disease or liver disease decreasing survival (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or ALAT > 3 x ULN
  5. Creatinine clearance < 30 ml/min
  6. Acute bacterial endocarditis
  7. Active bleeding or high risk for bleeding.
  8. Uncontrolled hypertension (investigators judgement)
  9. Intake of another experimental drug within the 30 days prior to randomization into the study
  10. Life expectancy <6 months
  11. Childbearing potential without proper contraceptive measures*, pregnancy or breast feeding
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Boehringer Ingelheim Study Coordinator1-800-243-0127clintriage.rdg@boehringer-ingelheim.com
Location Countries  ICMJEUnited States,   Australia,   Austria,   Belgium,   Canada,   Czech Republic,   Estonia,   Germany,   Italy,   Korea, Republic of,   Latvia,   Lithuania,   Netherlands,   New Zealand,   Norway,   Poland,   Russian Federation,   Singapore,   South Africa,   Sweden,   Switzerland,   Thailand

Administrative Information

NCT ID  ICMJENCT00558259
Responsible PartyBoehringer Ingelheim, Study Chair, Boehringer Ingelheim
Study ID Numbers  ICMJE1160.63, 2007-002586-12
Study Sponsor  ICMJEBoehringer Ingelheim Pharmaceuticals
Collaborators  ICMJE 
Investigators  ICMJE
Study Chair:Boehringer IngelheimBoehringer Ingelheim Pharmaceuticals
Information Provided ByBoehringer Ingelheim Pharmaceuticals