Official Title: “Twice-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.”

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).

Study Type: Interventional

Study Design: Prevention, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: November 2009

Intervention(s) in this Clinical Trial

• Drug: dabigatran etexilate
  • 150 mg bid
• Drug: placebo
  • NA bid

Primary Measures

• 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
    

Secondary Measures

• 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
    

Inclusion Criteria:

• 1. Patients with confirmed symptomatic PE or proximal DVT who have been treated for 6 to 18 month with therapeutic dosages (intended INR between 2-3) of an oral VKA (e.g., warfarin, acenocoumarol, phenprocoumon, or fluindione) up to the moment of randomization 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Boehringer Ingelheim Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Chair Boehringer Ingelheim Pharmaceuticals  

Overall Contact: Boehringer Ingelheim Study Coordinator  clintriage@boehringer-ingelheim.com

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00558259

Study ID Number: 1160.63

ClinicalTrials.gov Identifier: NCT00558259

Health Authority: United States: Food and Drug Administration