Embolism, Thrombosis
Conditions
Keywords
Deep venous thrombosis, pulmonary embolism, anticoagulant drugs
Brief summary
Objectives are to evaluate whether idrabiotaparinux sodium (SSR126517E) is as least as effective as a standard warfarin treatment to prevent recurrence of venous thromboembolic events (VTE) in patients with symptomatic pulmonary embolism (PE) with or without symptomatic deep venous thrombosis (DVT) and to assess its safety (bleedings) versus warfarin.
Detailed description
Treatment with a therapeutic dose of any low molecular weight heparin (LMWH) or unfractioned heparin (UFH) or fondaparinux is allowed only within the 36 hours immediately preceding randomization. Randomization is performed as soon as the diagnosis of PE (and DVT if concomitant suspected symptomatic DVT) is confirmed. Allocation to treatment is done centrally by Interactive Voice Response System (IVRS) and stratified by (1) center, (2) intended treatment duration, ie, 3 months or 6 months. At randomization, the planned duration of treatment (3 or 6 months) is prespecified by the Investigator and determined on the assessment of risk of VTE recurrence. Participants are randomized to either idrabiotaparinux + placebo of warfarin, or warfarin + placebo of idrabiotaparinux, with an initial treatment of at least 5 days with enoxaparin in both treatment groups. Participants in the 3-month stratum have an additional 13-week observational period after cessation of study treatment. Participants in the 6-month stratum have a 13-week up to 26-week observational period.
Interventions
0.5 mL pre-filled syringe for 3.0 mg Subcutaneous injection
DRUGWarfarin
Capsules with 1 or 5 mg for INR-adjusted dose (INR checked at least once a month) Oral administration
DRUGPlacebo (for idrabiotaparinux sodium)
0.5 mL pre-filled syringe Subcutaneous injection
DRUGAvidin
100 mg in 10 mg/mL solution Intravenous infusion for 30 minutes
Warfarin matching capsules Oral administration
DRUGEnoxaparin
Prefilled syringes as locally registered Subcutaneous injection
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Symptomatic pulmonary embolism with or without symptomatic deep vein thrombosis
Exclusion criteria
* End stage renal failure, hepatic failure, uncontrolled hypertension; * Active bleeding or high risk for bleeding; * Pregnancy or childbearing potential without proper contraceptive measures, threatened abortion. * Breastfeeding. * Known allergy to idraparinux or idrabiotaparinux, avidin or egg proteins; * hypersensitivity to warfarin, enoxaparin, heparin or pork product; or any other contraindication listed in the labelling of warfarin or enoxaparin; * Indication of prolonged anticoagulation therapy for other reason than PE; * Life expectancy \< 6 months;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence of symptomatic, fatal or not, VTE (PE or DVT) as confirmed by a Central Independent Adjudication Committee (CIAC) | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence of symptomatic, fatal or not, VTE (PE or DVT) as confirmed by a Central Independent Adjudication Committee (CIAC) | 6 months |
| Incidence of any clinically relevant bleeding as classified by the CIAC (ie, major bleeding and other clinically relevant non major bleeding) | 3 months, 6 months and 3- to 6-month post-treatment follow-up |
Countries
Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Egypt, Estonia, France, Greece, India, Israel, Italy, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Puerto Rico, Russia, Slovakia, South Africa, Spain, Sweden, Turkey (Türkiye), Ukraine, United Kingdom, United States
Outcome results
None listed