Oral Direct Factor Xa Inhibitor BAY 59-7939 in Patients with acute symptomatic Deep Vein Thrombosis. A phase II dose finding and proof of principle trial.ODIXa-DVT
- Conditions
- Deep vein thrombosisCardiovascular - Other cardiovascular diseases
- Registration Number
- ACTRN12605000601639
- Lead Sponsor
- Bayer Australia Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 600
Patients with acute symptomatic proximal deep vein thrombosis (objectively confirmed by complete compression ultrasound).
Related to medical historyTIA or ischemic stroke within the last 6 months prior to study entry.History of heparin-induced thrombocytopenia, allergy to heparins.Intracerebral or intraocular bleeding within the last 6 months prior to study entry.History of gastrointestinal bleeding within the last 6 months prior to the study.History or presence of gastrointestinal disease which could result in an impaired absorption of the study drug.Related to current symptoms or findingsFemale with childbearing potential using no adequate contraception method.Pregnant and breastfeeding women.Symptomatic pulmonary embolism.Surgery either major or minor within the last 10 days.Neurosurgery within the last 4 weeks.Heart insufficiency NYHA III-IV.Bacterial endocarditis.Known congenital or acquired hemorrhagic diathesis including patients with acquired or congenital thrombopathy.Thrombocytopenia.Macroscopic hematuria.Uncontrolled severe hypertension.Impaired liver function (transaminases > 2 x ULN).Impaired renal function.Patients with known brain metastases.Patients receiving cytotoxic chemotherapy.Life-expectancy < 6 months.Presence of active peptic ulcer or gastrointestinal disease with increased risk of gastrointestinal bleeding or any other increased risk for bleeding (eg diabetic retinopathy).Body weight < 45 kg.Drug-or alcohol abuse.Related to current treatment Therapy with oral anticoagulants, heparins or factor Xa inhibitors other than study medication are not allowed.Therapy with platelet aggregation inhibitors must be stopped prior to randomization. Patients where continued treatment with platelet aggregation inhibitors is clinically indicated will be excluded. The therapy with acetylicsalicylic acid at daily doses up to 500 mg/d is allowed during the study and prior to randomization. Any treatment prior to randomization with heparins (exception: unfractionated heparin treatment within 36 hours, 2 therapeutic doses of a LMWH 24 hours apart or 3 therapeutic doses of a LMWH 12 hours apart. Prophylactic doses of UFH or LMWH are allowed).Fibrinolytic agents are not allowed during the study.All other drugs influencing coagulation (exception: NSAIDs with half-life < 17 hours) are not allowed during the study.Systemic and local topical treatment with azole compounds and other strong CYP3A4 inhibitors are not allowed within 4 days prior to randomization and during the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The response to treatment as determined by Complete Compression Ultrasound (CCUS)[After 3 weeks of treatment.]
- Secondary Outcome Measures
Name Time Method Response to treatment as assessed by CCUS.[At Day 84];Residual vein diameter as assessed by CCUS.[On Day 84.];Incidence of symptomatic and confirmed recurrence or extension of DVT.[During the 3 months treatment period.];Incidence of symptomatic and confirmed PE[During the 3 months treatment period.];Composite endpoint of symptomatic and confirmed recurrence and extension of DVT and symptomatic PE (nonfatal DVT and/or nonfatal PE) and deaths[During the 3 months treatment period.];Composite endpoint of symptomatic and confirmed recurrence and extension of DVT and symptomatic PE (nonfatal DVT and/or nonfatal PE) and deaths related to VTE[During the 3 months treatment period.];Incidence of symptomatic and confirmed recurrence and extension of DVT and symptomatic PE.[Within 30 days after stop of treatment with study drug.]