E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | |
E.1.1.1 | Medical condition in easily understood language |
Patients who are verified to have had deep venous thrombosis and/or pulmonary embolism |
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E.1.1.2 | Therapeutic area | Diseases [C] - Blood and lymphatic diseases [C15] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049909 |
E.1.2 | Term | Venous thromboembolism prophylaxis |
E.1.2 | System Organ Class | 100000004865 |
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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 |
To determine the primary outcome event rate in patients taking generic rosuvastatin compared to placebo. |
|
E.2.2 | Secondary objectives of the trial |
1.To determine the major bleeding event rate in patients taking generic rosuvastatin compared to placebo. 2.To explore if rosuvastatin reduces the incidence of PTS, as measured by the Villalta scale at end of study. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Symptomatic objectively confirmed proximal leg DVT (above the trifurcation of the popliteal vein) and/or PE (segmental or greater) diagnosed in the last 30 days. |
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E.4 | Principal exclusion criteria |
1. Unable or unwilling to provide written informed consent; 2. ≤ 18 years of age; 3. Women of childbearing potential1 unwilling to use appropriate contraception2; 4. Currently prescribed a statin; 5. A known medical history or current diagnosis of any of the following: ➢ Diabetes; ➢ Abdominal aortic aneurysm; ➢ Peripheral arterial disease presumed to be of atherosclerotic origin; ➢ Stroke; ➢ Transient ischemic attack (TIA); ➢ Myocardial infarction (MI); ➢ Acute coronary syndromes; ➢ Stable/unstable angina; ➢ Coronary or other arterial revascularization. 6. Known diagnosis of hypercholesterolemia or dyslipidemia; 7. Contraindication to rosuvastatin; ➢ Known hypersensitivity or intolerance to statins; ➢ History of muscle disorders or statin-related muscle pain; ➢ Known liver disease (active liver disease or unexplained elevations of serum transaminases exceeding 3 times the upper limit of normal); ➢ Chronic kidney disease (Creatinine clearance < 30ml/min within previous 3 months); ➢ Currently pregnant or breast-feeding; ➢ Taking cyclosporine; ➢ Taking atazanavir/ritonavir. 8. Unstable medical or psychological condition that would interfere with trial participation |
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E.5 End points |
E.5.1 | Primary end point(s) |
Symptomatic recurrent major VTE (proximal DVT or segmental or larger PE) occurring between randomization and the end of follow-up (i.e. completion of the trial) in patients taking generic rosuvastatin as compared with placebo |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Between randomization of the first patient and end of study - maximum 5 years. |
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E.5.2 | Secondary end point(s) |
➢ Post-thrombotic syndrome as measured by the Villalta score; ➢ Non-major VTE; o Distal DVT (distal to the trifurcation of the popliteal vein); o Isolated sub-segmental PE; o Upper Extremity DVT; o Unusual site DVT o Superficial phlebitis > 5 cm; o Superficial phlebitis ≤ 5 cm; ➢ Components of composite arterial vascular events; o Fatal myocardial infarction; o Non-fatal myocardial infarction; o Hospitalization for unstable angina; o Coronary artery revascularization; o Sudden cardiac death; o Ischemic stroke. ➢ All-cause mortality (adjudication not required).
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Between randomisation of the first patient and end of study, last patient last visit - maximum 5 years. |
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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 | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 3 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Canada |
France |
Italy |
Netherlands |
Norway |
|
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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |