Clinical Study Assessing SSR126517E Injections Once-weekly in Pulmonary Embolism Therapeutic Approach

Thrombosis Clinical Trial

— CASSIOPEA  

Official title:

An International, Multicenter, Randomized, Double-blind, Double-dummy, Parallel Group, Study of 3-month or 6-month Treatment With SSR126517E (3.0 mg s.c. Once-weekly) Versus Oral INR-adjusted Warfarin in the Treatment of Patients With Symptomatic Pulmonary Embolism With or Without Symptomatic Deep Venous Thrombosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00345618
• Other study ID #: EFC6034
• Secondary ID: EudraCT:2006-001
• Status: Completed
• Phase: Phase 3
• First received: June 27, 2006
• Last updated: December 6, 2013
• Start date: June 2006
• Est. completion date: October 2010

Study information

• Verified date: December 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

Objectives are to evaluate whether idrabiotaparinux (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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3202
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• Idrabiotaparinux
0.5 mL pre-filled syringe for 3.0 mg Subcutaneous injection
• Warfarin
Capsules with 1 or 5 mg for INR-adjusted dose (INR checked at least once a month) Oral administration
• Placebo (for idrabiotaparinux)
0.5 mL pre-filled syringe Subcutaneous injection
• Avidin
100 mg in 10 mg/mL solution Intravenous infusion for 30 minutes
• Placebo (for warfarin)
Warfarin matching capsules Oral administration
• Enoxaparin
Prefilled syringes as locally registered Subcutaneous injection
• Placebo (for avidin)
Avidin matching powder in 10 mg/mL solution Intravenous infusion for 30 minutes

Locations

Country	Name	City	State
Argentina	Sanofi-Aventis Administrative Office	Buenos Aires
Australia	sanofi-aventis Australia & New Zealand administrative office	Macquarie Park	New South Wales
Austria	Sanofi-Aventis Administrative Office	Wien
Belarus	Sanofi-Aventis Administrative Office	Minsk
Belgium	Sanofi-Aventis Administrative Office	Diegem
Brazil	Sanofi-Aventis Administrative Office	Sao Paulo
Bulgaria	Sanofi-Aventis Administrative Office	Sofia
Canada	Sanofi-Aventis Administrative Office	Laval
Chile	Sanofi-Aventis Administrative Office	Santiago
China	Sanofi-Aventis Administrative Office	Shangai
Colombia	Sanofi-Aventis Administrative Office	Santafe de Bogota
Croatia	Sanofi-Aventis Administrative Office	Zagreb
Czech Republic	Sanofi-Aventis Administrative Office	Praha
Denmark	Sanofi-Aventis Administrative Office	Horsholm
Egypt	Sanofi-Aventis Administrative Office	Cairo
Estonia	Sanofi-Aventis Administrative Office	Tallinn
France	Sanofi-Aventis Administrative Office	Paris
Greece	Sanofi-Aventis Administrative Office	Athens
India	Sanofi-Aventis Administrative Office	Mumbai
Israel	Sanofi-Aventis Administrative Office	Natanya
Italy	Sanofi-Aventis Administrative Office	Milano
Mexico	Sanofi-Aventis Administrative Office	Mexico
Netherlands	Sanofi-Aventis Administrative Office	Gouda
Norway	Sanofi-Aventis Administrative Office	Lysaker
Peru	Sanofi-Aventis Administrative Office	Lima
Philippines	Sanofi-Aventis Administrative Office	Makati City
Poland	Sanofi-Aventis Administrative Office	Warszawa
Portugal	Sanofi-Aventis Administrative Office	Porto Salvo
Puerto Rico	Sanofi-Aventis Administraive Office	Puerto Rico
Russian Federation	Sanofi-Aventis Admnistrative Office	Moscow
Slovakia	Sanofi-Aventis Administrative Office	Brastislava
South Africa	Sanofi-Aventis Administrative Office	Midrand
Spain	Sanofi-Aventis Administrative Office	Barcelona
Sweden	Sanofi-Aventis Administrative Office	Bromma
Turkey	Sanofi-Aventis Administrative Office	Istanbul
Ukraine	Sanofi-Aventis Administrative Office	Kiev
United Kingdom	Sanofi-Aventis Administrative Office	Guildford Surrey
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belarus,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Colombia,  Croatia,  Czech Republic,  Denmark,  Egypt,  Estonia,  France,  Greece,  India,  Israel,  Italy,  Mexico,  Netherlands,  Norway,  Peru,  Philippines,  Poland,  Portugal,  Puerto Rico,  Russian Federation,  Slovakia,  South Africa,  Spain,  Sweden,  Turkey,  Ukraine,  United Kingdom, 

References & Publications (1)

Büller 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-d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of symptomatic, fatal or not, VTE (PE or DVT) as confirmed by a Central Independent Adjudication Committee (CIAC)		3 months	No
Secondary	Recurrence of symptomatic, fatal or not, VTE (PE or DVT) as confirmed by a Central Independent Adjudication Committee (CIAC)		6 months	No
Secondary	Incidence of any clinically relevant bleeding as classified by the CIAC (ie, major bleeding and other clinically relevant non major bleeding)		3 months, 6 months and 3- to 6-month post-treatment follow-up	Yes