Clinical Study Assessing Idrabiotaparinux Sodium Injections Once-weekly in Pulmonary Embolism Therapeutic Approach
CASSIOPEA
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
2 other identifiers
interventional
3,202
35 countries
35
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2006
Typical duration for phase_3
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 27, 2006
CompletedFirst Posted
Study publicly available on registry
June 28, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedMarch 21, 2016
February 1, 2016
4.3 years
June 27, 2006
February 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrence of symptomatic, fatal or not, VTE (PE or DVT) as confirmed by a Central Independent Adjudication Committee (CIAC)
3 months
Secondary Outcomes (2)
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)
3 months, 6 months and 3- to 6-month post-treatment follow-up
Study Arms (2)
Idrabiotaparinux
EXPERIMENTALIdrabiotaparinux 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 COMPARATORWarfarin, 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).
Interventions
0.5 mL pre-filled syringe for 3.0 mg Subcutaneous injection
Capsules with 1 or 5 mg for INR-adjusted dose (INR checked at least once a month) Oral administration
100 mg in 10 mg/mL solution Intravenous infusion for 30 minutes
Prefilled syringes as locally registered Subcutaneous injection
Eligibility Criteria
You may qualify if:
- Symptomatic pulmonary embolism with or without symptomatic deep vein thrombosis
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (38)
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807, 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
Related Publications (1)
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.
PMID: 22130488RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ICD CSD
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2006
First Posted
June 28, 2006
Study Start
June 1, 2006
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
March 21, 2016
Record last verified: 2016-02