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

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Venous Thromboembolism

Treatments: Drug: dabigatran etexilate 150 mg twice daily (BID); Drug: matching placebo twice daily (BID)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00558259

2007-002586-12 (EudraCT Number)

1160.63

Details and patient eligibility

About

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).

Enrollment: 1,353 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,353 participants in 2 patient groups, including a placebo group

dabigatran etexilate 150 mg BID

Experimental group

Description:

Patient to receive dabigatran etexilatate capsules 150 mg twice daily

Treatment:

Drug: dabigatran etexilate 150 mg twice daily (BID)

matching placebo twice daily (BID)

Placebo Comparator group

Description:

Patient to receive dabigatran extexilate matching placebo capsules twice daily

Treatment:

Drug: matching placebo twice daily (BID)