Phase 3 N=1,343 Randomized Double-blind Prevention

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

Venous Thromboembolism

Bottom Line

View on ClinicalTrials.gov: NCT00558259 ↗

Enrolled (actual)

1,343

Serious AEs

8.0%

Results posted

Mar 2012

Primary outcome: Primary: Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period — 3; 37 Participants — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: dabigatran etexilate 150 mg twice daily (BID) (Drug); matching placebo twice daily (BID) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Boehringer Ingelheim
Primary completion: Feb 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period	3; 37	<0.0001 sig
SECONDARY Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Excluding Unexplained Death During the Intended Treatment Period	3; 35	<0.0001 sig
SECONDARY Centrally Confirmed Symptomatic Recurrent Deep Venous Thrombotic (DVT) Events During the Intended Treatment Period	2; 23	< 0.0001 sig
SECONDARY Centrally Confirmed Symptomatic Pulmonary Embolism (PE) Events During the Intended Treatment Period	1; 14	0.0004 sig
SECONDARY Centrally Confirmed Unexplained Deaths During the Intended Treatment Period	0; 2	0.2428
SECONDARY Centrally Confirmed Bleeding Event During the Treatment Period	2; 0; 36; 12; 72; 39	0.4998
SECONDARY Centrally Confirmed Cardiovascular Events During the Treatment Period	3; 2	—
SECONDARY Laboratory Measures, Especially Liver Function Tests (LFTs)	2; 2; 3; 5; 0; 0	—

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).

Eligibility Criteria

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)
Intake of another experimental drug within the 30 days prior to randomization into the study
Life expectancy <6 months
Childbearing potential without proper contraceptive measures*, pregnancy or breast feeding

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00558259). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.