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

Sanofi3,202 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

3,202

Conditions

Embolism Thrombosis

Interventions

Idrabiotaparinux sodiumDRUG

0.5 mL pre-filled syringe for 3.0 mg Subcutaneous injection

WarfarinDRUG

Capsules with 1 or 5 mg for INR-adjusted dose (INR checked at least once a month) Oral administration

Placebo (for idrabiotaparinux sodium)DRUG

0.5 mL pre-filled syringe Subcutaneous injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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;

Locations (38)

Outcomes

Primary Outcomes

Recurrence of symptomatic, fatal or not, VTE (PE or DVT) as confirmed by a Central Independent Adjudication Committee (CIAC)

Time frame: 3 months

Secondary Outcomes

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

Data from ClinicalTrials.gov

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