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

NCT ID: NCT00345618

Last Updated: 2016-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 3202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2010-10-31

Brief 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.

Detailed Description

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.

Conditions

Embolism; Thrombosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Idrabiotaparinux

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).

Group Type: EXPERIMENTAL

Idrabiotaparinux sodium

Intervention Type: DRUG

0.5 mL pre-filled syringe for 3.0 mg

Subcutaneous injection

Avidin

Intervention Type: DRUG

100 mg in 10 mg/mL solution

Intravenous infusion for 30 minutes

Placebo (for warfarin)

Intervention Type: DRUG

Warfarin matching capsules

Oral administration

Enoxaparin

Intervention Type: DRUG

Prefilled syringes as locally registered

Subcutaneous injection

Warfarin

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).

Group Type: ACTIVE_COMPARATOR

Warfarin

Intervention Type: DRUG

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

Oral administration

Placebo (for idrabiotaparinux sodium)

Intervention Type: DRUG

0.5 mL pre-filled syringe

Subcutaneous injection

Avidin

Intervention Type: DRUG

100 mg in 10 mg/mL solution

Intravenous infusion for 30 minutes

Enoxaparin

Intervention Type: DRUG

Prefilled syringes as locally registered

Subcutaneous injection

Interventions

Idrabiotaparinux sodium

0.5 mL pre-filled syringe for 3.0 mg

Subcutaneous injection

Intervention Type: DRUG

Warfarin

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

Oral administration

Intervention Type: DRUG

Placebo (for idrabiotaparinux sodium)

0.5 mL pre-filled syringe

Subcutaneous injection

Intervention Type: DRUG

Avidin

100 mg in 10 mg/mL solution

Intravenous infusion for 30 minutes

Intervention Type: DRUG

Placebo (for warfarin)

Warfarin matching capsules

Oral administration

Intervention Type: DRUG

Enoxaparin

Prefilled syringes as locally registered

Subcutaneous injection

Intervention Type: DRUG

Other Intervention Names

Biotinylated Idraparinux; SSR126517; SSR29261

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ICD CSD

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Sanofi-Aventis Administrative Office

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

Countries

United States; Argentina; Australia; Austria; Belarus; Belgium; Brazil; Bulgaria; Canada; Chile; China; Colombia; Croatia; Czechia; Denmark; Egypt; Estonia; France; Greece; India; Israel; Italy; Mexico; Netherlands; Norway; Peru; Philippines; Poland; Portugal; Puerto Rico; Russia; Slovakia; South Africa; Spain; Sweden; Turkey (Türkiye); Ukraine; United Kingdom

References

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.

Reference Type: RESULT

PMID: 22130488 (View on PubMed)

Other Identifiers

EudraCT:2006-001786-42

Identifier Type: -

Identifier Source: secondary_id

EFC6034

Identifier Type: -

Identifier Source: org_study_id