ong-term treatment for cancer patients with deep venous thrombosis or pulmonary embolism - ND

Conditions: Venous thromboembolism including deep vein thrombosis and pulmonary embolism
MedDRA version: 9.1Level: HLTClassification code 10037379
MedDRA version: 9.1Level: PTClassification code 10051055

Registration Number: EUCTR2009-015336-15-IT

Lead Sponsor: IVERSITA` DEGLI STUDI G. D`ANNUNZIO CHIETI

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 pulmonary embolism or deep vein thrombosis who have been treated for 6 to 12 months with therapeutic doses of low molecular weight heparin, vitamin K antagonist or a new anticoagulant in a trial 2. Indication for long-term anticoagulant therapy (e.g. because of metastasized disease or chemotherapy) 3 Written informed consent
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 deep vein thrombosis or pulmonary embolism 3. Any contraindication listed in the local labeling of low molecular weight heparins, warfarin or vitasmin K antagonists 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: The primary efficacy objective is to evaluate whether low-molecular-weight heparin is superior to vitamin K antagonists in the long-term treatment of symptomatic venous thromboembolism in cancer patients who have completed 6 to 12 months of anticoagulant treatment;Secondary Objective: None;Primary end point(s): The primary efficacy outcome is symptomatic recurrent venous thromboembolism, i.e. the composite of recurrent deep vein thrombosis and fatal or non-fatal pulmonary embolism

Secondary Outcome Measures