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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00345618




Registration number
NCT00345618
Ethics application status
Date submitted
27/06/2006
Date registered
28/06/2006
Date last updated
21/03/2016

Titles & IDs
Public title
Clinical Study Assessing Idrabiotaparinux Sodium Injections Once-weekly in Pulmonary Embolism Therapeutic Approach
Scientific 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
Secondary ID [1] 0 0
EudraCT:2006-001786-42
Secondary ID [2] 0 0
EFC6034
Universal Trial Number (UTN)
Trial acronym
CASSIOPEA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Embolism 0 0
Thrombosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Idrabiotaparinux sodium
Treatment: Drugs - Warfarin
Treatment: Drugs - Placebo (for idrabiotaparinux sodium)
Treatment: Drugs - Avidin
Treatment: Drugs - Placebo (for warfarin)
Treatment: Drugs - Enoxaparin

Experimental: Idrabiotaparinux - Idrabiotaparinux 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).

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 over-dosage).


Treatment: Drugs: Idrabiotaparinux sodium
0.5 mL pre-filled syringe for 3.0 mg
Subcutaneous injection

Treatment: Drugs: Warfarin
Capsules with 1 or 5 mg for INR-adjusted dose (INR checked at least once a month)
Oral administration

Treatment: Drugs: Placebo (for idrabiotaparinux sodium)
0.5 mL pre-filled syringe
Subcutaneous injection

Treatment: Drugs: Avidin
100 mg in 10 mg/mL solution
Intravenous infusion for 30 minutes

Treatment: Drugs: Placebo (for warfarin)
Warfarin matching capsules
Oral administration

Treatment: Drugs: Enoxaparin
Prefilled syringes as locally registered
Subcutaneous injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Recurrence of symptomatic, fatal or not, VTE (PE or DVT) as confirmed by a Central Independent Adjudication Committee (CIAC)
Timepoint [1] 0 0
3 months
Secondary outcome [1] 0 0
Recurrence of symptomatic, fatal or not, VTE (PE or DVT) as confirmed by a Central Independent Adjudication Committee (CIAC)
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Incidence of any clinically relevant bleeding as classified by the CIAC (ie, major bleeding and other clinically relevant non major bleeding)
Timepoint [2] 0 0
3 months, 6 months and 3- to 6-month post-treatment follow-up

Eligibility
Key inclusion criteria
- Symptomatic pulmonary embolism with or without symptomatic deep vein thrombosis
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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;

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2010
Sample size
Target
Accrual to date
Final
3202
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
sanofi-aventis Australia & New Zealand administrative office - Macquarie Park
Recruitment postcode(s) [1] 0 0
- Macquarie Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New Jersey
Country [2] 0 0
Argentina
State/province [2] 0 0
Buenos Aires
Country [3] 0 0
Austria
State/province [3] 0 0
Wien
Country [4] 0 0
Belarus
State/province [4] 0 0
Minsk
Country [5] 0 0
Belgium
State/province [5] 0 0
Diegem
Country [6] 0 0
Brazil
State/province [6] 0 0
Sao Paulo
Country [7] 0 0
Bulgaria
State/province [7] 0 0
Sofia
Country [8] 0 0
Canada
State/province [8] 0 0
Laval
Country [9] 0 0
Chile
State/province [9] 0 0
Santiago
Country [10] 0 0
China
State/province [10] 0 0
Shangai
Country [11] 0 0
Colombia
State/province [11] 0 0
Santafe de Bogota
Country [12] 0 0
Croatia
State/province [12] 0 0
Zagreb
Country [13] 0 0
Czech Republic
State/province [13] 0 0
Praha
Country [14] 0 0
Denmark
State/province [14] 0 0
Horsholm
Country [15] 0 0
Egypt
State/province [15] 0 0
Cairo
Country [16] 0 0
Estonia
State/province [16] 0 0
Tallinn
Country [17] 0 0
France
State/province [17] 0 0
Paris
Country [18] 0 0
Greece
State/province [18] 0 0
Athens
Country [19] 0 0
India
State/province [19] 0 0
Mumbai
Country [20] 0 0
Israel
State/province [20] 0 0
Natanya
Country [21] 0 0
Italy
State/province [21] 0 0
Milano
Country [22] 0 0
Mexico
State/province [22] 0 0
Mexico
Country [23] 0 0
Netherlands
State/province [23] 0 0
Gouda
Country [24] 0 0
Norway
State/province [24] 0 0
Lysaker
Country [25] 0 0
Peru
State/province [25] 0 0
Lima
Country [26] 0 0
Philippines
State/province [26] 0 0
Makati City
Country [27] 0 0
Poland
State/province [27] 0 0
Warszawa
Country [28] 0 0
Portugal
State/province [28] 0 0
Porto Salvo
Country [29] 0 0
Puerto Rico
State/province [29] 0 0
Puerto Rico
Country [30] 0 0
Russian Federation
State/province [30] 0 0
Moscow
Country [31] 0 0
Slovakia
State/province [31] 0 0
Brastislava
Country [32] 0 0
South Africa
State/province [32] 0 0
Midrand
Country [33] 0 0
Spain
State/province [33] 0 0
Barcelona
Country [34] 0 0
Sweden
State/province [34] 0 0
Bromma
Country [35] 0 0
Turkey
State/province [35] 0 0
Istanbul
Country [36] 0 0
Ukraine
State/province [36] 0 0
Kiev
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Guildford Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00345618
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ICD CSD
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00345618