ong-term treatment for cancer patients with deep vein thrombosis or pulmonary embolism - a randomized open label study

Conditions: Deep venous thrombosis or pulmonary embolism in patients with cancer
MedDRA version: 12.0Level: LLTClassification code 10066899Term: Venous thromboembolism

Registration Number: EUCTR2009-015336-15-NL

Lead Sponsor: Department of Vascular Medicine of the Academic Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 1000

Inclusion Criteria

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)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Legal age limitations (country specific)
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 <3 months

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate whether low-molecular-weight heparin (Enoxaparin, Dalteparine, Nadroparine, Tinzaparine) is superior to vitamin K antagonists (VKA) in the long-term treatment of symptomatic venous thromboembolism in cancer patients who have completed 6 to 12 months of anticoagulant treatment ;Secondary Objective: Not applicable;Primary end point(s): The primary efficacy outcome is symptomatic recurrent VTE, i.e. the composite of recurrent DVT and fatal or non-fatal PE.

Secondary Outcome Measures