heart failure patients (III-IV NYHA) MedDRA version: 9.1 Level: HLGT Classification code 10019280 Term: Heart failures
Conditions
Interventions
Trade Name: ARIXTRA
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Fondaparinux
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-
Sponsors
AZIENDA OSPEDALIERA UNIVERSITARIA CAREGGI
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: 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.;Primary end point(s): Circulating D-dimer plasma levels 2 months after enrolment | — |
Countries
Italy
Outcome results
None listed