Patients with confirmed acute symptomatic pulmonary embolism with or without confirmed acute symptomatic deep vein thrombosis of the lower limbs. MedDRA version: 8.1 Level: PT Classification code 10037377 Term: Pulmonary embolism
Conditions
Interventions
Product Name: biotinylated idraparinux
Product Code: SSR126517E
Pharmaceutical Form: Solution for injection
CAS Number: 405159-59-3
Curr
Sponsors
sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Confirmed acute symptomatic PE with or without confirmed acute symptomatic DVT of the lower limbs. 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: 1. Legal lower age limitations (country specific) 2. Women with childbearing potential without proper contraceptive measures 3. Written informed consent not obtained 4. Other indication than current episode of PE for anticoagulation 5. Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of PE 6. Treatment with a therapeutic dose of any LMWH or UFH or fondaparinux for more than 36 hours immediately preceding randomization 7. Life expectancy < 6 months 8. Participation, within the prior 30 days, in another pharmacotherapeutic study with non-registered investigational product 9. Pregnancy 10. Threatened abortion 11. Active major bleeding 12. Hemorrhagic tendencies or blood dyscrasias 13. Recent or contemplated surgery of central nervous system, eye, traumatic surgery resulting in large open surfaces 14. Spinal puncture and other diagnostic or therapeutic procedures with potential for uncontrollable bleeding 15. Malignant hypertension 16. Unsupervised patients with senility, alcoholism, or psychosis, or other lack of patient cooperation 17. Known hypersensitivity to warfarin or to any other component of this product 18. Patients with hypersensitivity to enoxaparin sodium, heparin, or pork products 19. Any other contraindication listed in your local warfarin or enoxaparin labeling, not listed above 20. Breast-feeding 21. Creatinine clearance < 10mL/min or end-stage renal failure (i.e. need for renal replacement therapy such as renal transplantation, hemodialysis or peritoneal dialysis). 22. Hypersensitivity to idraparinux or SSR126517E 23. Known allergy to avidin or egg proteins
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary efficacy objective is to evaluate whether a 3- or 6-month treatment with once-weekly SSR126517E s.c. injections is at least as effective as a 3- or 6-month treatment with INR-adjusted warfarin in the treatment and prevention of VTE recurrence at 3 months in patients with symptomatic PE with or without symptomatic DVT.;Secondary Objective: The secondary efficacy objective is to evaluate whether a 6-month treatment with once-weekly SSR126517E s.c injections is at least as effective as a 6-month treatment with INR-adjusted warfarin in the treatment and prevention of VTE recurrence at 6 months in patients with symptomatic PE with or without symptomatic DVT.; Primary end point(s): The primary efficacy endpoint is symptomatic fatal or non-fatal recurrent PE/DVT within 3 months. | — |
Countries
Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Greece, Italy, Netherlands, Portugal, Slovakia, Spain, Sweden, United Kingdom
Outcome results
None listed