E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
acutely ill immobilized medical patients |
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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 primary objective is to confirm that certoparin is non-inferior in preventing the primary endpoint consisting of proximal deep vein thrombosis (DVT), symptomatic non-fatal pulmonary embolism (PE) and venous thromboembolism (VTE) related death during treatment when compared to unfractionated heparin (UFH) in acutely ill medical patients. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to evaluate the efficacy of certoparin compared to UFH in preventing the individual components of the primary endpoint and other clinically important endpoints during treatment when compared to UFH in the study population. These endpoints are: • proximal and distal DVT (combined and separately), • symptomatic DVT, • symptomatic non-fatal PE, • combination of proximal DVT, non fatal PE and death from all causes including PE • VTE related death, • death from all causes, • documented symptomatic VTE (PE and/or DVTs, during follow up period).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Hospitalized medical patients 70 years of age or older 2. Acute medical illness with significant decrease in mobility expected for at least 4 days (patient bedridden or only able to walk short distances) 3. written informed consent
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E.4 | Principal exclusion criteria |
1. immobilization longer than 3 days prior to randomization 2. prior major surgery, trauma or invasive procedure within the last 4 weeks including any injuries or operation of central nervous system 3. expected major surgical or invasive procedure within 3 weeks following randomization (e.g. thoracic surgery; but permitted are: e.g. uncomplicated angiography, gastroscopy) 4. patients with severe sepsis or need for ventilatory support (permitted are CPAP, oxygen via mask etc.) 5. LMWH/heparin administration longer than 48 hours in the 5 days prior to randomization 6. immobilization due to cast or fracture 7. indication for anticoagulatory or thrombolytic therapy 8. life expectancy < 6 months or illness with very high acute mortality (> 30%) 9. acute symptomatic DVT / PE 10. known hypersensitivity to any of the study drugs or drugs with similar chemical structures 11. Acute or history of heparin induced thrombocytopenia type II (HIT II) 12. hemorrhagic diathesis, deficiency of coagulation factors, severe thrombocytopenia 13. acute or history of non-hemorrhagic stroke (< 3 months); hemorrhagic stroke or intracranial bleeding (< 12 months) 14. acute or ongoing intracranial disease, e.g. cerebral aneurysm 15. high risk of gastrointestinal bleeding 16. spinal or epidural anesthesia, lumbar punction within the last 12 hours 17. uncontrolled hypertension, RRdiast. > 105 mmHg 18. severe liver disease 19. severe renal dysfunction (estimated GFR < 30 ml/min, Cockcroft-Gault or MDRD formula) 20. acute endocarditis 21. known active retinopathy, intravitreal or other intraocular bleeding 22. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer 23. Subjects unlikely to comply with the requirements of the protocol.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is a composite endpoint occurring during treatment. The composite endpoint consists of: • proximal deep vein thrombosis • symptomatic non-fatal pulmonary embolism • venous thromboembolism related death
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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 | 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 | 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) | 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 | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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 | 41 |
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 | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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 |
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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 | 2 |
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 | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |