| - candidate number | 2267 |
| - NTR Number | NTR784 |
| - ISRCTN | ISRCTN07836779 |
| - Date ISRCTN created | 28-dec-2006 |
| - date ISRCTN requested | 18-dec-2006 |
| - Date Registered NTR | 27-sep-2006 |
| - Secondary IDs | N/A |
| - Public Title | 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. |
| - Scientific Title | 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. |
| - ACRONYM | NOSTRADAMUS |
| - hypothesis | Testing for thrombophilia after a first episode of VTE with subsequent prolongation of anticoagulant treatment in thrombophilic patients is beneficial in terms of clinical outcomes, quality of life, and costs. |
| - Healt Condition(s) or Problem(s) studied | Pulmonary embolism, Deep vein thrombosis |
| - 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 |
| - mec approval received | yes |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | None |
| - control | Active |
| - group | Parallel |
| - Type | [default] |
| - Studytype | intervention |
| - planned startdate | 1-okt-2006 |
| - planned closingdate | 1-apr-2010 |
| - Target number of participants | 1336 |
| - Interventions | 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 |
| - Primary outcome | recurrent VTE 18 months after the acute episode of VTE |
| - Secondary outcome | 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 |
| - Timepoints | |
| - Trial web site | N/A |
| - status | stopped |
| - CONTACT FOR PUBLIC QUERIES | Dr. S. Middeldorp |
| - CONTACT for SCIENTIFIC QUERIES | Dr. S. Middeldorp |
| - Sponsor/Initiator | Academic Medical Center (AMC), Department of Vascular Medicine |
| - Funding (Source(s) of Monetary or Material Support) | ZON-MW, The Netherlands Organization for Health Research and Development, Netherlands Heart Foundation (NHS, Nederlandse Hartstichting) |
| - Publications | N/A |
| - Brief summary | A randomized controlled trial of testing and no testing for thrombophilia in patients with a first episode of VTE will be performed. Subsequent additional anticoagulant treatment for a predefined period will be installed in those in whom thrombophilia is detected in the testing group, while others will receive a standard predefined duration of treatment. In addition, the impact on quality of life of thrombophilia testing will be measured. Efficacy and safety outcomes are risk for recurrent VTE and clinically important bleeding (also as a composite outcome). Other outcomes are overall quality of life and costs associated with the outcome measures 18 months after the initial episode of VTE. Outcomes will be compared between thrombophilic patients allocated to the testing group and to the no testing group. A total of 1336 patients will have to be included to detect a benefit of 90% by prolonging anticoagulant treatment in patients with thrombophilia while on treatment, and no reduction in the 6 months after cessation of treatment (overall RRR 55%) [power 80%, CI 95%]. |
| - Main changes (audit trail) | |
| - RECORD | 27-sep-2006 - 25-jan-2008 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl