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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00345618
First received: June 27, 2006
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Embolism
Thrombosis
Drug: Idrabiotaparinux
Drug: Warfarin
Drug: Placebo (for idrabiotaparinux)
Drug: Avidin
Drug: Placebo (for warfarin)
Drug: Enoxaparin
Drug: Placebo (for avidin)
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Recurrence of symptomatic, fatal or not, VTE (PE or DVT) as confirmed by a Central Independent Adjudication Committee (CIAC) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recurrence of symptomatic, fatal or not, VTE (PE or DVT) as confirmed by a Central Independent Adjudication Committee (CIAC) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Incidence of any clinically relevant bleeding as classified by the CIAC (ie, major bleeding and other clinically relevant non major bleeding) [ Time Frame: 3 months, 6 months and 3- to 6-month post-treatment follow-up ] [ Designated as safety issue: Yes ]

Enrollment: 3202
Study Start Date: June 2006
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Idrabiotaparinux

Idrabiotaparinux, 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 overdosage).

Drug: Idrabiotaparinux

0.5 mL pre-filled syringe for 3.0 mg

Subcutaneous injection

Other Names:
  • Biotinylated Idraparinux
  • SSR126517
Drug: Avidin

100 mg in 10 mg/mL solution

Intravenous infusion for 30 minutes

Other Name: SSR29261
Drug: Placebo (for warfarin)

Warfarin matching capsules

Oral administration

Drug: Enoxaparin

Prefilled syringes as locally registered

Subcutaneous injection

Active Comparator: 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 overdosage).

Drug: Warfarin

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

Oral administration

Drug: Placebo (for idrabiotaparinux)

0.5 mL pre-filled syringe

Subcutaneous injection

Drug: Enoxaparin

Prefilled syringes as locally registered

Subcutaneous injection

Drug: Placebo (for avidin)

Avidin matching powder in 10 mg/mL solution

Intravenous infusion for 30 minutes


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00345618

  Hide Study Locations
Locations
United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Argentina
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
Australia, New South Wales
sanofi-aventis Australia & New Zealand administrative office
Macquarie Park, New South Wales, Australia
Austria
Sanofi-Aventis Administrative Office
Wien, Austria
Belarus
Sanofi-Aventis Administrative Office
Minsk, Belarus
Belgium
Sanofi-Aventis Administrative Office
Diegem, Belgium
Brazil
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
Bulgaria
Sanofi-Aventis Administrative Office
Sofia, Bulgaria
Canada
Sanofi-Aventis Administrative Office
Laval, Canada
Chile
Sanofi-Aventis Administrative Office
Santiago, Chile
China
Sanofi-Aventis Administrative Office
Shangai, China
Colombia
Sanofi-Aventis Administrative Office
Santafe de Bogota, Colombia
Croatia
Sanofi-Aventis Administrative Office
Zagreb, Croatia
Czech Republic
Sanofi-Aventis Administrative Office
Praha, Czech Republic
Denmark
Sanofi-Aventis Administrative Office
Horsholm, Denmark
Egypt
Sanofi-Aventis Administrative Office
Cairo, Egypt
Estonia
Sanofi-Aventis Administrative Office
Tallinn, Estonia
France
Sanofi-Aventis Administrative Office
Paris, France
Greece
Sanofi-Aventis Administrative Office
Athens, Greece
India
Sanofi-Aventis Administrative Office
Mumbai, India
Israel
Sanofi-Aventis Administrative Office
Natanya, Israel
Italy
Sanofi-Aventis Administrative Office
Milano, Italy
Mexico
Sanofi-Aventis Administrative Office
Mexico, Mexico
Netherlands
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Norway
Sanofi-Aventis Administrative Office
Lysaker, Norway
Peru
Sanofi-Aventis Administrative Office
Lima, Peru
Philippines
Sanofi-Aventis Administrative Office
Makati City, Philippines
Poland
Sanofi-Aventis Administrative Office
Warszawa, Poland
Portugal
Sanofi-Aventis Administrative Office
Porto Salvo, Portugal
Puerto Rico
Sanofi-Aventis Administraive Office
Puerto Rico, Puerto Rico
Russian Federation
Sanofi-Aventis Admnistrative Office
Moscow, Russian Federation
Slovakia
Sanofi-Aventis Administrative Office
Brastislava, Slovakia
South Africa
Sanofi-Aventis Administrative Office
Midrand, South Africa
Spain
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sweden
Sanofi-Aventis Administrative Office
Bromma, Sweden
Turkey
Sanofi-Aventis Administrative Office
Istanbul, Turkey
Ukraine
Sanofi-Aventis Administrative Office
Kiev, Ukraine
United Kingdom
Sanofi-Aventis Administrative Office
Guildford Surrey, United Kingdom
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

Publications:
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00345618     History of Changes
Other Study ID Numbers: EFC6034, EudraCT:2006-001786-42
Study First Received: June 27, 2006
Last Updated: December 6, 2013
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Ethics Commission

Keywords provided by Sanofi:
Deep venous thrombosis
pulmonary embolism
anticoagulant drugs

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Thromboembolism
Anticoagulants
Warfarin
Enoxaparin
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 23, 2014