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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT:2006-001786-42 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Idrabiotaparinux | Experimental | 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). |
|
| Warfarin | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Idrabiotaparinux sodium | Drug | 0.5 mL pre-filled syringe for 3.0 mg Subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of symptomatic, fatal or not, VTE (PE or DVT) as confirmed by a Central Independent Adjudication Committee (CIAC) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of symptomatic, fatal or not, VTE (PE or DVT) as confirmed by a Central Independent Adjudication Committee (CIAC) | 6 months | |
| Incidence of any clinically relevant bleeding as classified by the CIAC (ie, major bleeding and other clinically relevant non major bleeding) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ICD CSD | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Bridgewater | New Jersey | 08807 | United States | ||
| Sanofi-Aventis Administrative Office |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22130488 | Result | 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. |
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| Warfarin | Drug | 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 |
|
| Avidin | Drug | 100 mg in 10 mg/mL solution Intravenous infusion for 30 minutes |
|
|
| Placebo (for warfarin) | Drug | Warfarin matching capsules Oral administration |
|
| Enoxaparin | Drug | Prefilled syringes as locally registered Subcutaneous injection |
|
| 3 months, 6 months and 3- to 6-month post-treatment follow-up |
| Buenos Aires |
| Argentina |
| sanofi-aventis Australia & New Zealand administrative office | Macquarie Park | New South Wales | Australia |
| Sanofi-Aventis Administrative Office | Vienna | Austria |
| Sanofi-Aventis Administrative Office | Minsk | Belarus |
| Sanofi-Aventis Administrative Office | Diegem | Belgium |
| Sanofi-Aventis Administrative Office | São Paulo | Brazil |
| Sanofi-Aventis Administrative Office | Sofia | Bulgaria |
| Sanofi-Aventis Administrative Office | Laval | Canada |
| Sanofi-Aventis Administrative Office | Santiago | Chile |
| Sanofi-Aventis Administrative Office | Shanghai | China |
| Sanofi-Aventis Administrative Office | Bogotá | Colombia |
| Sanofi-Aventis Administrative Office | Zagreb | Croatia |
| Sanofi-Aventis Administrative Office | Prague | Czechia |
| Sanofi-Aventis Administrative Office | Hørsholm | Denmark |
| Sanofi-Aventis Administrative Office | Cairo | Egypt |
| Sanofi-Aventis Administrative Office | Tallinn | Estonia |
| Sanofi-Aventis Administrative Office | Paris | France |
| Sanofi-Aventis Administrative Office | Athens | Greece |
| Sanofi-Aventis Administrative Office | Mumbai | India |
| Sanofi-Aventis Administrative Office | Netanya | Israel |
| Sanofi-Aventis Administrative Office | Milan | Italy |
| Sanofi-Aventis Administrative Office | México | Mexico |
| Sanofi-Aventis Administrative Office | Gouda | Netherlands |
| Sanofi-Aventis Administrative Office | Lysaker | Norway |
| Sanofi-Aventis Administrative Office | Lima | Peru |
| Sanofi-Aventis Administrative Office | Makati City | Philippines |
| Sanofi-Aventis Administrative Office | Warsaw | Poland |
| Sanofi-Aventis Administrative Office | Porto Salvo | Portugal |
| Sanofi-Aventis Administraive Office | San Juan | Puerto Rico |
| Sanofi-Aventis Admnistrative Office | Moscow | Russia |
| Sanofi-Aventis Administrative Office | Brastislava | Slovakia |
| Sanofi-Aventis Administrative Office | Midrand | South Africa |
| Sanofi-Aventis Administrative Office | Barcelona | Spain |
| Sanofi-Aventis Administrative Office | Bromma | Sweden |
| Sanofi-Aventis Administrative Office | Istanbul | Turkey (Türkiye) |
| Sanofi-Aventis Administrative Office | Kiev | Ukraine |
| Sanofi-Aventis Administrative Office | Guildford Surrey | United Kingdom |
| ID | Term |
|---|---|
| D004617 | Embolism |
| D013927 | Thrombosis |
| D020246 | Venous Thrombosis |
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D014859 | Warfarin |
| D001360 | Avidin |
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010047 | Ovalbumin |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D015387 | Egg Proteins, Dietary |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D004527 | Egg Proteins |
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
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