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

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

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).

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

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Antithrombins; Dabigatran; Thrombin

Criteria

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