Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long-term Prevention of Recurrent Symptomatic Proximal Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis or Pulmonary Embolism.
- NCT00558259
- PHASE3
- INTERVENTIONAL
Last updated: 2014-06-27
Purpose of Trial
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).
This study is for people with
Venous Thromboembolism
Interventions being studied
dabigatran etexilate 150 mg twice daily (BID)
matching placebo twice daily (BID)
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
ELIGIBILITY
Gender: ALL
Age: 18+
Healthy Volunteers: No
21 Locations
Birmingham
1160.63.01025 Boehringer Ingelheim Investigational Site
Alabama, United States
Huntsville
1160.63.01023 Boehringer Ingelheim Investigational Site
Alabama, United States
Laguna Hills
1160.63.01002 Boehringer Ingelheim Investigational Site
California, United States
Colorado Springs
1160.63.01014 Boehringer Ingelheim Investigational Site
Colorado, United States
Jacksonville
1160.63.01003 Boehringer Ingelheim Investigational Site
Florida, United States
Key West
1160.63.01030 Boehringer Ingelheim Investigational Site
Florida, United States
Lafayette
1160.63.01022 Boehringer Ingelheim Investigational Site
Louisiana, United States
New Iberia
1160.63.01044 Boehringer Ingelheim Investigational Site
Louisiana, United States
Biddeford
1160.63.01017 Boehringer Ingelheim Investigational Site
Maine, United States
Salisbury
1160.63.01004 Boehringer Ingelheim Investigational Site
Maryland, United States
Worcester
1160.63.01016 Boehringer Ingelheim Investigational Site
Massachusetts, United States
St. Louis
1160.63.01037 Boehringer Ingelheim Investigational Site
Missouri, United States
Missoula
1160.63.01019 Boehringer Ingelheim Investigational Site
Montana, United States
Columbus
1160.63.01032 Boehringer Ingelheim Investigational Site
Ohio, United States
Uniontown
1160.63.01001 Boehringer Ingelheim Investigational Site
Pennsylvania, United States
Uniontown
1160.63.01024 Boehringer Ingelheim Investigational Site
Pennsylvania, United States
Charleston
1160.63.01005 Boehringer Ingelheim Investigational Site
South Carolina, United States
Spartanburg
1160.63.01020 Boehringer Ingelheim Investigational Site
South Carolina, United States
Salt Lake City
1160.63.01011 Boehringer Ingelheim Investigational Site
Utah, United States
Richmond
1160.63.01007 Boehringer Ingelheim Investigational Site
Virginia, United States
Bellevue
1160.63.01035 Boehringer Ingelheim Investigational Site
Washington, United States
Primary Contact(s)
Boehringer Ingelheim
Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at
ClinicalTrials.gov