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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR784 |
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Date of registration:
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27/09/2006 |
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Primary sponsor: |
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Public title:
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NOSTRADAMUS: Testing for thrombophilia in patients with a first episode of venous thromboembolism (VTE): a randomized controlled trial to assess effects on clinical outcomes, quality of life, and costs.
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Scientific title:
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NOSTRADAMUS: Testing for thrombophilia in patients with a first episode of venous thromboembolism: a randomized controlled trial to assess effects on clinical outcomes, quality of life, and costs. - NOSTRADAMUS |
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Date of first enrolment:
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1/10/2006 |
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Target sample size:
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1336 |
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Recruitment status: |
other |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=784 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: [default]
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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S.
Middeldorp |
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Address:
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Academic Medical Center (AMC), Department of Vascular Medicine, F4-276,
P.O. Box 22660, Meibergdreef 9
1100 DD
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 5665976 |
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Email:
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alife@amc.uva.nl |
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Affiliation:
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Name:
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S.
Middeldorp |
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Address:
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Academic Medical Center (AMC), Department of Vascular Medicine, F4-276,
P.O. Box 22660, Meibergdreef 9
1100 DD
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 5665976 |
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Email:
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alife@amc.uva.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Subjects must be willing and able to give written informed consent
2. Confirmed symptomatic DVT, i.e., proximal vein or extensive calf-vein
thrombosis, involving at least the upper third part of the deep calf veins (trifurcation, AND/OR confirmed symptomatic PE, no longer than 2 months prior to randomization
3. age 18 years or older
Exclusion criteria: 1. Previous episodes of DVT or PE
2. Active bleeding or high risk for bleeding contraindicating treatment with LMWH, fondaparinux or VKA
3. Insertion of a caval filter to treat the episode of VTE
4. Active cancer or anti-cancer treatment in the 6 months prior to the acute episode of VTE
5. Life expectancy < 18 months
6. Arterial thrombotic events in the context of a confirmed antiphospholipid antibody syndrome
7. Indications for VKA other than DVT
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Pulmonary embolism, Deep vein thrombosis
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Intervention(s)
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Randomization between disclosure and undisclosure of results of thrombophilia screening and subsequent additional anticoagulant treatment for a predefined period will be installed in those in whom thrombophilia is detected in the disclosure group
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Primary Outcome(s)
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recurrent VTE 18 months after the acute episode of VTE
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Secondary Outcome(s)
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1. Recurrent VTE at the end of the study
2. A composite endpoint of recurrent VTE and bleeding at the end of the study
3. Quality of life
4. costs of testing and subsequent predefined prolongation of anticoagulant therapy
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Secondary ID(s)
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ISRCTN07836779
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N/A
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Source(s) of Monetary Support
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ZON-MW, The Netherlands Organization for Health Research and Development, Netherlands Heart Foundation (NHS, Nederlandse Hartstichting)
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