Acute syntomatic deep vein thrombosis MedDRA version: 7.0 Classification code 10051055
Conditions
Sponsors
Bayer HealthCare AG
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 2X ULN), or bacterial endocarditis - Life expectancy 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objectives of this Phase II dose finding trial are to assess the dose-effect relationship of once-daily BAY 59-7939 in the treatment of patients with confirmed acute symptomatic deep vein thrombosis, using the combination of (LMW) heparin and VKA as comparator. The objective is also to determine the optimum once daily dose of BAY 59-7939 for use in phase III studies. Pharmacokinetic and pharmacodynamic parameters (incl, activated partial thrombin time (aPTT), INR, Factor Xa activity and Heptest) will also be assessed. ;Secondary Objective: ;Primary end point(s): The primary efficacy endpoint will be the composite of syntomatic recurrent DVT or syntomatic fatal and non-fatal PE at 12 weeks and deterioration in thrombotic burden, as assessed by CUS and PLS, at basekine and at 12 weeks.. Secondary efficacy endpoints : - The separate components of the primary efficacy outcome at 12 weeks The following definitions are applied by the CIAC to confirm a suspected episode of symptomatic recurrent PE/DVT: 1. Suspected PE with one of the following findings: - a (new) intraluminal filling defect in (sub)segmental or more proximal branches on spiral CT scan - a (new) intraluminal filling defect or an extension of an existing defect or a new sudden cutoff of vessels more than 2.5 mm in diameter on the pulmonary angiogram - a (new) perfusion defect of at least 75% of a segment with a local normal ventilation result (high-probability) on ventilation/perfusion lung scan (VPLS) or 2. Suspected recurrent DVT with one of the following findings: - abnormal CUS where compression had been normal or, if non-compressible at screening, a substantial increase (4 mm or more) in diameter of the thrombus during full compression - an extension of an intraluminal filling defect, or a new intraluminal filling defect or an extension of non-visualization of veins in the presence of a sudden cut-off on venography or 3. Fatal PE based on autopsy or 4. Death which cannot | — |
Countries
Czech Republic, Denmark, Italy, Sweden
Outcome results
None listed