Thrombosis Clinical Trial
Official title:
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
Objectives are to evaluate whether idrabiotaparinux (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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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