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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
  Purpose

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.


Condition Intervention Phase
Embolism
Thrombosis
 Drug: SSR126517E
Drug: warfarin
 Phase 3

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

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ]

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

Estimated Enrollment: 3200
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: 1 Drug: SSR126517E
subcutaneous route
Active Comparator: 2 Drug: warfarin
oral INR-adjusted

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.

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

  Show 38 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: ICD, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00345618     History of Changes
Other Study ID Numbers: EFC6034, EudraCT:2006-001786-42
Study First Received: June 27, 2006
Last Updated: October 13, 2010
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
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013