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

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).

Intervention(s) in this Clinical Trial

• Drug: dabigatran etexilate 150 mg BID
  • dabigatran etexilate capsules 150 mg BID
• Drug: matching placebo BID
  • Matching placebo BID

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: dabigatran etexilate 150 mg BID
  • Patient to receive dabigatran etexilatate capsules 150 mg twice daily
• Placebo Comparator: matching placebo BID
  • Patient to receive dabigatran extexilate matching placebo capsules twice daily

Primary Measures

• Major bleeding
  • Time Frame: on treatment
    Safety Issue?: Yes
• Symptomatic recurrent VTE, i.e., the composite of recurrent DVT or fatal or non fatal PE during the intended treatment period
  • Time Frame: 6 months
    Safety Issue?: No

Secondary Measures

• Clinical relevant bleeding, all deaths and cardiovascular events
  • Time Frame: on treatment
    Safety Issue?: Yes
• Composite of recurrent symptomatic DVT, recurrent non fatal PE and fatal PE where fatal PE is defined as PE based on objective testing, but excluding unexplained death AND the separate components of the primary efficacy outcome
  • Time Frame: 6 months
    Safety Issue?: No

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

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 Investigator: Boehringer Ingelheim Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Chair Boehringer Ingelheim Pharmaceuticals  

Information obtained from ClinicalTrials.gov on February 12, 2012

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

Study ID Number: 1160.63

ClinicalTrials.gov Identifier: NCT00558259

Health Authority: Australia: Dept of Health and Ageing Therapeutic Goods Admin