CompletedPhase 3

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

United States1,353 participantsStarted 2007-11

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.
✓. Written informed consent

Exclusion criteria

✕. Younger then 18 years of age
✕. Indication for VKA other than DVT and/or PE
✕. Patients in whom anticoagulant treatment for their index PE or DVT should be continued
✕. Active liver disease or liver disease decreasing survival (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or ALAT \> 3 x ULN
✕. Creatinine clearance \< 30 ml/min
✕. Acute bacterial endocarditis
✕. Active bleeding or high risk for bleeding.
✕. Uncontrolled hypertension (investigators judgement)

What they're measuring

Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period

Timeframe: 6 months

Trial details

NCT IDNCT00558259

SponsorBoehringer Ingelheim

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-02

Results submitted2012-01-31

View on ClinicalTrials.gov More Venous Thromboembolism trials