Once-daily oral Direct Factor Xa Inhibitor BAY 59-7939 in Patients with acute symptomatic Deep Vein Thrombosis. The Einstein-DVT dose-finding study. - Einstein-DVT dose-finding study

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 520

Inclusion Criteria

- Patients with confirmed acute symptomatic deep vein thrombosis i.e. proximal or extensive calf-vein thrombisis involving at least the upper third part of the calf veins, without concomitant symptomatic PE
- Patients who have signed an informed consent form for participation prior to study entry
Are the trial subjects under 18?
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

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 > 2X 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, acenocumarol, phenprocoumon, fluidione, UFH, enoxaparin, or tinzaparin
- Systemic treatment with azole compounds or other strong CYP3A4 inhibitors (e.g. ketoconazole, fluconazol, itraconazol, HIV protease inhibitors) within 4 days prior to randomization and during the study

Prior and concomitant medication
Medication prior to randomization

Therapeutic dosages of (LMW) heparin are allowed up to a maximum of 36 hours prior to randomization. The duration of prophilactic dosages of (LWM) heparin is not restricted. A single pre-randomization starting dose of VKA is also allowed.

Concomitant medication
Non-steroid anti-inflammatory drugs (NSAIDs) and antiplatelet agents are discouraged. However if indicated, aspirin up to a dosage of 100 mg/day as well as clopidogrel (75 mg/day) are allowed. Use of systemic treatment with azole compounds or other strong CYP3A4 inhibitors (e.g. ketoconazole, fluconazol, itraconazol, HIV protease inhibitors) within 4 days prior to randomization and during the study are not allowed

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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