Venous Thromboembolism
Conditions
Keywords
Treatment of venous thromboembolism
Brief summary
The purpose of this study is to determine the optimal dose of BAY 59-7939 and to compare the safety and effectiveness of this new drug with the standard way of treatment of deep vein thrombosis (heparin infusion plus one of the vitamin K antagonists), taking into account new events of thrombosis and pulmonary embolism and bleeding risk.
Detailed description
Within the U.S., Johnson & Johnson is sponsor.
Interventions
BAY59-7939 20 mg once daily (od) for 12 weeks
DRUG(LMW) Heparin + Vitamin K Antagonist
Low Molecular Weight (LMW) Heparin + Vitamin K Antagonist (VKA) for 5 days, then VKA only for the rest of 12 weeks
Sponsors
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed acute symptomatic DVT, i.e. proximal or extensive calf-vein thrombosis involving at least the upper third part of the calf veins, without concomitant symptomatic PE * Written informed consent
Exclusion criteria
* Legal lower age limitations (country specific) * Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT * Other indication for VKA than PE/DVT * More than 36 hours pre-randomization treatment with therapeutic dosages of (LMW) heparin or more than a single dose of VKA prior to randomization * Participation in another pharmacotherapeutic study within the prior 30 days * Creatinine clearance \< 30 mL/min, impaired liver function (transaminases \> 2 x ULN), or bacterial endocarditis * Life expectancy \< 3 months * Active bleeding or high risk for bleeding contraindicating treatment with (LMW) heparin * Uncontrolled hypertension: systolic blood pressure \> 200 mmHg and diastolic blood pressure \> 110 mmHg * Pregnancy or childbearing potential without proper contraceptive measures * Any other contraindication listed in the labeling of warfarin, acenocoumarol, phenprocoumon, fluindione, UFH, enoxaparin, or tinzaparin * Systemic treatment with azole compounds or other strong CYP3A4 inhibitors (e.g. ketoconazole, fluconazol, itraconazole, HIV protease inhibitors) within 4 days prior to randomization and during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint was the composite of symptomatic recurrent DVT or symptomatic fatal and non-fatal PE at 12 weeks and deterioration in thrombotic burden, as assessed by CUS and PLS, at baseline and at 12 weeks. | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| The principal safety outcome is all clinically relevant bleeding (i.e. major bleeding and clinically relevant non-major bleeding) within 12 weeks. | 12 weeks |
| The separate components of the primary efficacy outcome at 12 weeks. | 12 weeks |
Countries
Australia, Brazil, Canada, Czechia, Denmark, France, Israel, Italy, Netherlands, Poland, South Africa, Sweden, United States
Outcome results
None listed