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: 14.1Level: LLTClassification code 10066899Term: Venous thromboembolismSystem Organ Class: 100000004866; MedDRA version: 14.1Level: LLTClassification code 10049909Term: Venous thromboembolism prophylaxisSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2009-015336-15-DE
• Lead Sponsor: Department of Vascular Medicine of the Academic Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-28
• Last Update Posted: 1 April 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Patients with cancer and confirmed PE or DVT of the leg who have been treated for minimally 6 an maximally 12 months with therapeutic doses of anticoatulants, i.e. LMWH or VKA or a new anticoagulant in a trial;
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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

Indications for anticoagulant therapy other than DVT or PE;
Any contraindication listed in the SmPc of the anticoagulant used;
Life expectancy under 3 months

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified