Extended anticoagulation for thrombosis patients showing an activated coagulation system as detected by a simple blood test.
- Conditions
- Female and male patients having suffered from venous thrombosis or pulmonary thromboembolism being treated with oral anticoagulant therapy (OAT)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2006-006823-38-DE
- Lead Sponsor
- Rheinische Friedrichs-Wilhelms-Universität Bonn
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
To be enrolled in this study, patients must
•have an objectively confirmed first episode of unprovoced VTE or of VTE during a minor transient risk factor. Minor transient risk factors include
- 6 weeks of estrogen therapy
- prolonged air travel (i. e. > 6 hours)
- pregnancy
- less marked leg injuries or immobilization without injury or surgical intervention
•be scheduled to receive oral anticoagulant treatment for at least 3 months
•be willing to be randomized
•be willing to participate for the full duration of the study
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120
Exclusion criteria include
•pregnancy or breast feeding
•contraindications against OAT (i. e. intracranial hemorrhage, subarachnoid hemorrhage, hemorrhagic stroke)
•age < 18 years
•presence of antiphospholipid antibodies or any other thrombophilic risk factor requiring long-term OAT (i. e. antithrombin deficiency, hereditary PC deficiency)
•poor patient compliance
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