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

This study has been completed.

Sponsor:

Information provided by:

Sanofi

ClinicalTrials.gov Identifier:

NCT00345618

First received: June 27, 2006

Last updated: October 13, 2010

Last verified: October 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

June 27, 2006

Last Updated Date

October 13, 2010

Start Date ^ICMJE

June 2006

Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Recurrence of fatal and non fatal venous thrombo-embolic events (deep vein thrombosis or pulmonary embolism) [ Time Frame: at 3 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Recurrence of fatal and non fatal venous thrombo-embolic events (deep vein thrombosis or pulmonary embolism) at 3 months

Change History

Complete list of historical versions of study NCT00345618 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Recurrence of venous thrombo-embolic events at 6 months, bleedings [ Time Frame: over a 3- and 6-month period ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Recurrence of venous thrombo-embolic events at 6 months, bleedings over a 3- and 6-month period.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

To determine, in patients with clots in the lungs, whether SSR126517E is as least as effective as a standard warfarin treatment to prevent recurrence of clot in legs or lungs, and to assess its safety (bleedings) versus warfarin.

Detailed Description

Intravenous infusion of avidin (SSR29261) may be administered in case of severe bleeding, or overdose, or invasive procedure with the potential of ubncontyrolled bleeding.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Embolism
Thrombosis

Intervention ^ICMJE

Drug: SSR126517E
subcutaneous route
Drug: warfarin
oral INR-adjusted

Study Arm (s)

Experimental: 1
Intervention: Drug: SSR126517E
Active Comparator: 2
Intervention: Drug: warfarin

Publications *

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-dummy, non-inferiority trial. Lancet. 2012 Jan 14;379(9811):123-9. Epub 2011 Nov 28.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

3200

Completion Date

October 2010

Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 SSR126517E, avidin or egg proteins; hypersensitivity to warfarin, enoxaparin, heparin or pork product.
Indication of prolonged anticoagulation for other reason than PE.
Life expectancy < 6 months.
Any other contraindication listed in the labelling of warfarin or enoxaparin not listed above

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

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

Administrative Information

NCT Number ^ICMJE

NCT00345618

Other Study ID Numbers ^ICMJE

EFC6034, EudraCT:2006-001786-42

Has Data Monitoring Committee

Not Provided

Responsible Party

ICD, sanofi-aventis

Study Sponsor ^ICMJE

Sanofi

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

ICD CSD

Sanofi

Information Provided By

Sanofi

Verification Date

October 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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