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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 (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00345618
First received: June 27, 2006
Last updated: December 6, 2013
Last verified: December 2013

June 27, 2006
December 6, 2013
June 2006
October 2010   (final data collection date for primary outcome measure)
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 ]
Recurrence of fatal and non fatal venous thrombo-embolic events (deep vein thrombosis or pulmonary embolism) at 3 months
Complete list of historical versions of study NCT00345618 on ClinicalTrials.gov Archive Site
  • 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 ]
Recurrence of venous thrombo-embolic events at 6 months, bleedings over a 3- and 6-month period.
Not Provided
Not Provided
 
Clinical Study Assessing SSR126517E Injections Once-weekly in Pulmonary Embolism Therapeutic Approach
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Embolism
  • Thrombosis
  • Drug: Idrabiotaparinux

    0.5 mL pre-filled syringe for 3.0 mg

    Subcutaneous injection

    Other Names:
    • Biotinylated Idraparinux
    • SSR126517
  • 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: 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

  • Drug: Placebo (for avidin)

    Avidin matching powder in 10 mg/mL solution

    Intravenous infusion for 30 minutes

  • 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).

    Interventions:
    • Drug: Idrabiotaparinux
    • Drug: Avidin
    • Drug: Placebo (for warfarin)
    • Drug: Enoxaparin
  • 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).

    Interventions:
    • Drug: Warfarin
    • Drug: Placebo (for idrabiotaparinux)
    • Drug: Enoxaparin
    • Drug: Placebo (for avidin)
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. doi: 10.1016/S0140-6736(11)61505-5. Epub 2011 Nov 28. PubMed PMID: 22130488.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3202
October 2010
October 2010   (final data collection date for primary outcome measure)

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;
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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
 
NCT00345618
EFC6034, EudraCT:2006-001786-42
Yes
Sanofi
Sanofi
Not Provided
Study Director: ICD CSD Sanofi
Sanofi
December 2013

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