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

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.

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;