Efficacy and Safety of Dabigatran Compared to Warfarin for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism
Condition: Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism
Intervention: dabigatran etexilate 150 mg; warfarin (INR 2-3)
Intervention description: twice daily; prn to maintain INR (2-3)
Intervention MeSH terms: Warfarin; Dabigatran
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 2564.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this trial is to determine the comparative safety and efficacy of dabigatran
      etexilate 150 mg bid administered orally and warfarin as needed (pro re nata - prn) to
      maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute
      symptomatic venous thromboembolism (VTE), following initial treatment (5-10 days) with a
      parenteral anticoagulant approved for this indication. This trial aims to demonstrate
      non-inferiority of dabigatran compared with warfarin in patients with acute symptomatic VTE.
      After achieving non-inferiority, this trial also aims to establish superiority (by means of
      hierarchical tests) of dabigatran over warfarin.
    

Eligibility criteria:

        Inclusion criteria

          1. Acute deep vein thrombosis (DVT) of the leg involving proximal veins, and/or pulmonary
             embolism (PE) iin patients for whom at least 6 months of anticoagulant therapy is
             considered appropriate

          2. Male or female, being 18 years of age or older

          3. Written informed consent for study participation

        Exclusion criteria

          1. Overt symptoms of VTE for longer than 2 weeks prior to enrolment

          2. PE satisfying at least one of the following criteria: Haemodynamic instability,
             embolectomy is indicated or performed, thrombolytic therapy is indicated or performed,
             or suspected source of PE is other than the legs

          3. Actual or anticipated use of vena cava filter

          4. Contraindications to anticoagulant therapy

          5. Patients who in the investigators opinion should not be treated with warfarin

          6. Allergy to heparins or other alternate approved therapy used for initial treatment,
             warfarin or dabigatran, or to one of the excipients included in these medications

          7. Patients who in the investigators judgement are perceived as having an excessive risk
             of bleeding

          8. Known anaemia

          9. Need of anticoagulant treatment for disorders other than VTE

         10. Recent unstable cardiovascular disease

         11. Elevated AST or ALT > 2x ULN

         12. Liver disease expected to have any potential impact on survival

         13. Patients who have developed transaminase elevations upon exposure to ximelagatran

         14. Severe renal impairment

         15. Women who are pregnant, nursing, or of childbearing potential who refuse to use a
             medically acceptable form of contraception

         16. Participation in another clinical trial with an investigational drug during the last
             30 days or previous participation in this study

         17. Patients considered unsuitable for inclusion by the investigator