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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-015336-15-NL

Enrollment

1000

Registered

2009-08-25

Start date

2009-09-30

Completion date

Unknown

Last updated

2012-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Product Name: warfarin Pharmaceutical Form: Tablet INN or Proposed INN: WARFARIN CAS Number: 81812 Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 1000- Pro

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Germany, Italy, Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026