None listed
Conditions
Interventions
Group 1 Type of group
AVE5026.20 mg s.c. q.d. (10 mg q.d. for patients with IRS, defined as creatinine clearance
Enoxaparin, 40 mg s.c. q.d. (20 mg q.d. for patients with IRS)
Sponsors
sanofi-aventis Recherche & Development,
Eligibility
Age
40 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Patient with acute medical illness who needs to keep a bed for at least 3 days. • Age> 40 years • Hospitalized due to at least one of the following medical illnesses: - Congestive heart failure (NYHA class III / IV), Acute respiratory failure (not requiring mechanical ventilation), Acute infection (without septic shock), Acute rheumatic disease, Acute episode of inflammatory bowel disease • Signed written informed consent
Exclusion criteria
Exclusion criteria: • Prior surgery with general anesthesia within 30 days prior to inclusion • Any major surgery planned during the investigation treatment period • Any treatment with other antithrombotic agents within a period of 2 weeks before the randomized or planned assignment during the course of the study. • Subject that requires a curative anticoagulant or thrombolytic treatment. • Acute stroke. • When the subject is unlikely to comply with the protocol, for example, uncooperative attitude, inability to give informed consent, to return to follow-up visits, inability to receive daily injection (administered by a health care professional ) after being discharged from the hospital and unlikely to complete the study. • Treatment with any product under investigation or device under investigation during the last 30 days or 5 half-lives (if applicable) before randomization. • Any previous exposure to AVE5026 (for example in any previous clinical study of AVE5026). • Early survival <6 months • Major active bleeding • Thrombocytopenia associated with a positive in vitro test for antiplatelet antibodies in the presence of enoxaparin sodium. • Known hypersensitivity to enoxaparin sodium (for example, pruritus, hives, anaphylactoid reactions). • Known hypersensitivity to heparin or porcine products. • Conditions with an increased risk of bleeding, such as bacterial endocarditis, congenital or acquired bleeding disorders, active ulcerative and angiodysplastic gastrointestinal disease, hemorrhagic stroke, or shortly after brain, spine or ophthalmologic surgery. • End-stage disease (creatinine clearance calculated <10 mL / min [Appendix B]) or dialysis patients. • Pregnant or breastfeeding women. • Women with unprotected pregnancy potential with an effective birth control method of birth control, as defined for contraception in the Informed Consent Form during the study and / or who are not willing to undergo a pregnancy test or cannot do so .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:In case of clinical suspicion of DVT or PE, it is necessary to confirm or rule out the diagnosis using objective investigations: The clinical diagnosis of DVT should be confirmed by ultrasound with compression or venography. The clinical diagnosis of PD should be confirmed with a pulmonary ventilation examination. perfusion, pulmonary angiogram or pulmonary study with spiral computed tomography (CT). Measure:Combination of the following resulting events recorded until Day 15 or until the day of the Compression Ultrasound (CUS) mandatory [Day 10 -5], whichever comes first: DVT and / or pulmonary embolism and any death related to VTE Timepoints:Day 15 or until the day of the Compression Ultrasound (CUS) mandatory [Day 10 -5] | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The clinical diagnosis of DVT should be confirmed by ultrasound with compression or venography. Measure:Occurrence of any asymptomatic proximal DVT detected by CUS Timepoints:Day 15 or until the day of the mandatory CUS (whichever comes first) ; Outcome name:In case of clinical suspicion of DVT or PE, it is necessary to confirm or rule out the diagnosis using objective investigations: The clinical diagnosis of DVT should be confirmed by ultrasound with compression or venography. The clinical diagnosis of PD should be confirmed with a pulmonary ventilation examination. perfusion, pulmonary angiogram or pulmonary study with spiral computed tomography (CT). Measure:DVT and / or non-fatal pulmonary embolism (BP) confirmed in case of symptoms prior to the mandatory CUS date Timepoints:Day 15 or until the day of the mandatory CUS (whichever comes first) ; Outcome name:All deaths will be adjudicated by the CCIA for classification as death related to VTE, fatal bleeding or others. Measure:Any death related to VTE (fatal PE or unexplained deaths) Timepoints:Day 15 or until the day of the mandatory CUS (whichever comes first) | — |
Countries
Austria, Belgium, Czech Republic, Estonia, France, Germany, Hungary, Italy, Latovia, Lithuania, Netherlands, Peru, Poland, Portugal, Slovenia, Spain, United Kindgdom
Contacts
Public ContactAlexandra Vavoulis
ICON CLINICAL RESEARCH PERU S.A.
Outcome results
None listed