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

Phase 3 Completed 3202 enrolled Sanofi

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start: 2006-06
Primary completion: 2010-10
Completion: 2010-10

Outcome

Met primary endpoint

paper odds ratio 0·79, 95% CI 0·50-1·25; p(non-inferiority)=0·0001 PMID 22130488 ↗

Publications

Results Buller HR, Gallus AS, Pillion G, Prins MH, Raskob GE; Cassiopea Investigators. Enoxaparin followed by once-weekly idrabiotaparinux versus enoxaparin plus warfarin for patients with acute symptomatic pulmonary embolism: a randomised, double-blind, double-dummy, non-inferiority trial. Lancet. 2012 Jan 14;379(9811):123-9. doi: 10.1016/S0140-6736(11)61505-5. Epub 2011 Nov 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Idrabiotaparinux sodium	Unknown	3 mg	Subcutaneous
Subject	Warfarin	Small molecule	1 mg	Oral
Subject	Warfarin	Small molecule	5 mg	Oral
Background	Avidin	Unknown	100 mg	Intravenous
Background	Enoxaparin sodium	Other / unclassified	1 mg/kg	Subcutaneous