NCT00345618

Clinical Study Assessing Idrabiotaparinux Sodium Injections Once-weekly in Pulmonary Embolism Therapeutic Approach

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,202 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Embolism
• Thrombosis

Interventions

Type	Name	Description
DRUG	Idrabiotaparinux sodium	0.5 mL pre-filled syringe for 3.0 mg Subcutaneous injection
DRUG	Warfarin	Capsules with 1 or 5 mg for INR-adjusted dose (INR checked at least once a month) Oral administration
DRUG	Placebo (for idrabiotaparinux sodium)	0.5 mL pre-filled syringe Subcutaneous injection
DRUG	Avidin	100 mg in 10 mg/mL solution Intravenous infusion for 30 minutes
DRUG	Placebo (for warfarin)	Warfarin matching capsules Oral administration
DRUG	Enoxaparin	Prefilled syringes as locally registered Subcutaneous injection

Timeline

• Start date: 2006-06-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2006-06-28
• Last updated: 2016-03-21

Locations

38 sites across 38 countries: United States, 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