E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with a Venous Thromboembolism (VTE) |
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MedDRA Classification |
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 |
The overarching objective of this study is to improve the prevention and treatment of recurrent VTE and post-thrombotic syndrome in patients being treated for a first episode of a proximal (above the knee) unprovoked blood clot. |
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E.2.2 | Secondary objectives of the trial |
The secondary research objectives are to: Establish the preformance characteristics of D-dimer testing as a prediction tool for the recurrence of VTE in patients with a first unprovoked blood clot; Establish factors which contribute to the recurrence of VTE in patients with a first unprovoked blood clot; Determine the protective effect of prolonged warfarin therapy against post-thrombotic syndrome in patients with first unprovoked blood clot; Identify the cost-effectiveness and impact on patient quality of life of alternative approaches to delivery of care and treatment of patients with VTE. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
People aged 18 years or over with a diagnosis of first proximal unprovoked DVT or PE on treatment with anticoagulants; Patients who have completed 3 uninterrupted months of anticoagulant therapy. |
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E.4 | Principal exclusion criteria |
Patients under the age of 18 years Patients with another indication for long term warfarin therapy eg Atrial Fibrillation Patients with a diagnosis of first unprovoked proximal DVT or PE who are no longer on anticoagulation therapy Patients with a high incidence of bleeding as evidenced by any of the following: Patients with a previous episode of major bleeding where the cause was not effectively treated Known thrombocytopaenia with a platelet count of less than 120 x109 /L Known chronic renal failure with a creatinine of more than 150 µmols/L (1.7mg/dl) or eGFR less than 30 Known chronic liver disease with a total bilirubin of more than 25µmols/L (1.5mg/dl) Active peptic ulcer Patients requiring antiplatelet therapy (eg Aspirin and/or Clopidrogel) Patients with a vena cava filter in place Patients who have had a d–dimer test performed within 2 months of potential enrolment other than for evaluation for suspected recurrent VTE that was not confirmed Patients whose life expectancy less than 5 years Patients unable to attend follow up visits due to geographic inaccessibility Patients participating in a competing investigation Patients with known antiphospholipid syndrome Patients with known inherited protein C and/or protein S or antithrombin deficiency Patients with a diagnosis of active cancer Patients unwilling or unable to give consent Pregnant or breastfeeding women Women of child bearing potential (and men with partners of child bearing potential) will be required to practice effective contraception during the two years of their participation in the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The number of recurrent thrombotic events during the study. |
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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 | No |
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 | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
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 | 16 |
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 | No |
E.8.7 | Trial has a data monitoring committee | Yes |
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 | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |