Efficacy and Safety of Dabigatran Compared to Warfarin for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Dabigatran; Warfarin

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