E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
heart failure patients (III-IV NYHA) |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10019280 |
E.1.2 | Term | Heart failures |
|
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 evaluate the effects of fondaparinux on biochemical parameters and clinical events according to different duration of treatment in heart failure patients (III-IV NYHA). Primary end-point: circulating D-dimer plasma levels 2 months after enrolment |
|
E.2.2 | Secondary objectives of the trial |
Secondary endpoints: circulating thrombin-antithrombin complexes (TAT), prothrombin fragment 1+2 (F1+2), interleukin-6 (IL-6), C-Reactive Protein (CRP), Tumor necrosis factor-alpha (TNF-alpha) at discharge and 1, 2 and 12 months after enrolment. Circulating D-dimer plasma levels at discharge and 1, 12 months after enrolment. Total mortality, cardiovascular mortality and need of re-hospitalization 12 months after enrolment. Pulmonary emboly and/or deep vein thrombosis Minor and major bleeding. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Diagnosis of heart failure according to the Framingham criteria(III-IV NYHA) patients aged ≥ 60 years Patients with a planned hospital stay of at least 4 days |
|
E.4 | Principal exclusion criteria |
Ischemic or haemorrhagic stroke within 12 months prior to admission; Creatinin clearance < 20 ml/min; Cerebral metastasis; Acute bacterial endocarditis; neoplastic or connective tissue disease; a recent history(3 months) of brain, spinal, or ophthalmological surgery; an indwelling intrathecal or epidural catheter; oral anticoagulant therapy; an indication for anticoagulant prophylaxis or therapy; life expectancy of less than one month; use of any experimental drug within 30 days before admission; major psychiatric disorders; Abuse of alcohol and / or drugs in the last year. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Circulating D-dimer plasma levels 2 months after enrolment |
|
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 | No |
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) | 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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
stesso farmaco con durata differente della terapia |
|
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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
| |
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 | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |