ong-term treatment for cancer patients with deep vein thrombosis or pulmonary embolism - a randomized open label study
- Conditions
- venous thrombosis / clot1002765510014523
- Registration Number
- NL-OMON39493
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
1. Patients with cancer and confirmed PE or DVT of the leg who have been treated for minimally 6 and maximally 12 months with therapeutic doses of anticoagulants, i.e. LMWH or VKA or a new anticoagulant in a trial
2. Written informed consent
3. Indication for long-term anticoagulant therapy (e.g. because of metastasized disease, chemotherapy)
1.* 18 years of age or below the legal age of consent as per country specific regulations
2. Indications for anticoagulant therapy other than DVT or PE
3. Any contraindication listed in the local labeling of enoxaparin, dalteparin, tinzaparin, nadroparin, warfarin, acenocoumarol or fenprocoumon
4. Childbearing potential without proper contraceptive measures, pregnancy or breastfeeding
5. Life expectancy of less than 3 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy outcome is symptomatic recurrent VTE, i.e. the composite<br /><br>of recurrent DVT and fatal or non-fatal PE. The primary efficacy analysis is<br /><br>based on the time to the first symptomatic recurrent VTE event. The principal<br /><br>safety outcome is major bleeding. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Not applicable. </p><br>