A Phase 3 interventional study of Idrabiotaparinux sodium and Warfarin in Embolism and Thrombosis, sponsored by Sanofi. Completed at 38 sites in 38 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-21.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
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.
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.
739 studies on the registry are indexed under Pulmonary Embolism; 158 are open to participants now.
This study's enrollment of 3,202 is above the median of 150 across 381 interventional studies indexed under Pulmonary Embolism.
Browse Pulmonary Embolism studies →Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Idrabiotaparinux sodium, 3.0 mg, once-weekly for 3 or 6 months depending on the stratum, after enoxaparin, 1.0 mg/kg, every 12 hours for at least 5 days. Avidin, 100 mg, at the discretion of the investigator whenever deemed appropriate and possible (ie, life-threatening bleeding, emergency invasive procedure with the potential of uncontrolled bleeding, or over-dosage).
Drug: Idrabiotaparinux sodium · Drug: Avidin · Drug: Placebo (for warfarin) · Drug: Enoxaparin
Warfarin, INR-adjusted dose, started 24 hours after the start of enoxaparin, 1.0 mg/kg, every 12 hours for at least 5 days, and continued for 3 or 6 months depending on the stratum. Avidin, 100 mg, at the discretion of the investigator whenever deemed appropriate and possible (ie, life-threatening bleeding, emergency invasive procedure with the potential of uncontrolled bleeding, or over-dosage).
Drug: Warfarin · Drug: Placebo (for idrabiotaparinux sodium) · Drug: Avidin · Drug: Enoxaparin
0.5 mL pre-filled syringe for 3.0 mg Subcutaneous injection
Also known as: Biotinylated Idraparinux, SSR126517
Capsules with 1 or 5 mg for INR-adjusted dose (INR checked at least once a month) Oral administration
0.5 mL pre-filled syringe Subcutaneous injection
100 mg in 10 mg/mL solution Intravenous infusion for 30 minutes
Also known as: SSR29261
Warfarin matching capsules Oral administration
Prefilled syringes as locally registered Subcutaneous injection
Recurrence of symptomatic, fatal or not, VTE (PE or DVT) as confirmed by a Central Independent Adjudication Committee (CIAC)
Time frame: 3 months
Recurrence of symptomatic, fatal or not, VTE (PE or DVT) as confirmed by a Central Independent Adjudication Committee (CIAC)
Time frame: 6 months
Incidence of any clinically relevant bleeding as classified by the CIAC (ie, major bleeding and other clinically relevant non major bleeding)
Time frame: 3 months, 6 months and 3- to 6-month post-treatment follow-up
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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