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
- -I26I26
- Registration Number
- PER-072-08
- Lead Sponsor
- sanofi-aventis Recherche & Development,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Not specified
- Target Recruitment
- 0
• Acute symptomatic PE confirmed with or without confirmed acute symptomatic DVT of the lower extremities.
• Limitations of legal lower age (specific to each country).
• Women with reproductive potential who are not using adequate contraceptive measures.
• That written informed consent is not obtained.
• Another indication different from the current PE episode for anticoagulants.
• Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current PE episode.
• Treatment with a therapeutic dose of any LMWH or UFH or fondaparinux for more than 36 hours immediately before the random distribution.
• Life expectancy <6 months.
• Participation in the previous 30 days in any other pharmacotherapy study with an unregistered research product.
• Pregnancy.
• Threatened abortion.
• Major active bleeding.
• Hemorrhagic tendencies or blood dyscrasias.
• Surgical intervention of the recent or contemplated central nervous system of eyes, traumatic surgery that produces large open surfaces.
• Lumbar puncture and other diagnostic or therapeutic procedures with potential for uncontrolled bleeding
• Malignant hypertension.
• Unsupervised patients with senility, alcoholism or psychosis, or some other type of lack of cooperation from the patient.
• Known hypersensitivity to warfarin or any other component of this product.
• Patients with hypersensitivity to enoxaparin sodium, heparin or pork products.
• Any other contraindication listed on your local warfarin or enoxaparin label, not listed above (see Appendix C).
• Breastfeeding.
• Creatinine clearance <10 ml / min or end-stage renal failure *
• Hypersensitivity to idraparinux or SSR126517E.
• Known allergy to avidin or egg proteins.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:The diagnosis of PE relapse will be made exclusively using pulmonary irrigation / ventilation scanning, helical computed tomography (CT) scanning, pulmonary angiography, alone or in combination, and compression ultrasonography (CUS) in case of lung scanning or scanning by Helical CT inconclusive.<br>The diagnosis of DVT will preferably be made by bilateral venography or CUS (including measurement of the diameter of the iliac, common femoral, popliteal and trifurcated veins, before and after compression) in the lower extremities.<br>Measure:Symptomatic PE / DVT relapse (fatal or not), validated by the CIAC, within 99 days of the random distribution in patients of both strata.<br>Timepoints:within 99 days of the random distribution<br>
- Secondary Outcome Measures
Name Time Method