E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
A randomized controlled trial of testing and no testing for thrombophilia in patients with a first episode of venous thrombosis or pulmonary embolism (venous thromboembolism, 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. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10047249 |
E.1.2 | Term | Venous thrombosis |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
This study aims to assess efficacy and safety of testing for thrombophilia in patients with a first episode of VTE and subsequent additional anticoagulant treatment in those in whom thrombophilia is detected as compared to no testing and standard duration of therapy in all patients.
The primary efficacy outcome consists of: •recurrent VTE 18 months after the acute episode of VTE.
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E.2.2 | Secondary objectives of the trial |
Secondary efficacy outcomes are: •recurrent VTE at the end of the study. •a composite endpoint of recurrent VTE and bleeding at the end of the study •quality of life •costs of testing and subsequent predefined prolongation of anticoagulant therapy
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
1: PREDICT aims to develop a prognostic tool that may be used to predict recurrent venous thrombosis in patients treated for a first venous thrombosis (Version 1.1, July 15 2006).
2: Residual thrombosis at discontinuation of anticoagulant therapy. This substudy aims to assess the predictive value of residual thrombosis at the time of discontinuation of anticoagulant therapy on recurrent thrombosis (Version 1.1, July 15 2006).
3: DIAGNOSTIC aims to assess the value of testing for thrombophilia after a first episode of VTE: the consequences and responses to disclosure of test-results (Version 1.1, July 15 2006).
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E.3 | Principal 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
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E.4 | Principal exclusion criteria |
Target Disease Exceptions 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
Medical History and Concurrent Diseases 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
Prohibited Therapies and/or Medications 7. Indications for VKA other than DVT
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy outcome consists of: • recurrent VTE 18 months after the acute episode of VTE.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |