None listed
Conditions
Interventions
Group 1 Type of group
Warfarin (or its placebo) should be started within 24 hours after randomization and administered for a period of 3 or 6 months depending on the baseline risk factors for VTE recurrence. The dose of warfarin (or its placebo) will be adjusted to maintain the centralized INR (true or simulated) within the therapeutic range (goal 2.5, range 2.0-3.0).
Group name:Group 2 Type of group
Injections of SSR126517E (or its placebo) will begin 12 h after the last post-randomized enoxaparin administration. SSR126517E (or your placebo) will be administered s.c. once a week for a period of 3 or 6 months. All patients will receive a first injection of 0.5 ml (3 mg in the SSR126517E group). The following injections will also be 0.5 ml, except in patients with severe renal insufficiency
Sponsors
sanofi-aventis Recherche & Development,
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: • Acute symptomatic PE confirmed with or without confirmed acute symptomatic DVT of the lower extremities.
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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. Measure:Symptomatic PE / DVT relapse (fatal or not), validated by the CIAC, within 99 days of the random distribution in patients of both strata. Timepoints:within 99 days of the random distribution | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. 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. Measure:Symptomatic PE / DVT recurrence of lower extremities, validated by the CIAC, in a period of 190 days. Timepoints:190 days. ; 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. 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. Measure:Time to first recurrence of symptomatic PE / DVT within the patients treatment period Timepoints:3 and 6 months | — |
Countries
Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Greece, Italy, Netherlands, Peru, Portugal, Spain, Sweden, United Kindgdom
Contacts
Public ContactPablo Acevedo
SANOFI AVENTIS DEL PERU S.A.
Outcome results
None listed