An international, multicenter, randomized, double-blind, double-dummy, parallel group, study of 3-month or 6-month treatment with SSR126517E (3.0 mg s.c. once weekly) versus oral INR-adjusted warfarin in the treatment of patients with symptomatic pulmonary embolism, with or without symptomatic deep venous thrombosis - CASSIOPEA

Conditions: Patients with confirmed acute symptomatic pulmonary embolism with or without confirmed acute symptomatic deep vein thrombosis of the lower limbs.
MedDRA version: 8.1Level: PTClassification code 10037377Term: Pulmonary embolism

Registration Number: EUCTR2006-001786-42-CZ

Lead Sponsor: sanofi-aventis recherche et développement

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 3200

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

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 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 the labeling of warfarin, or enoxaparin, 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br><br>;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 Outcome Measures