Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00345618
Status:
COMPLETED
Last Update Posted:
2016-03-21
First Post:
2006-06-27
Brief Title:
Clinical Study Assessing Idrabiotaparinux Sodium Injections Once-weekly in Pulmonary Embolism Therapeutic Approach
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
An International Multicenter Randomized Double-blind Double-dummy Parallel Group Study of 3-month or 6-month Treatment With SSR126517E 30 mg sc Once-weekly Versus Oral INR-adjusted Warfarin in the Treatment of Patients With Symptomatic Pulmonary Embolism With or Without Symptomatic Deep Venous Thrombosis
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CASSIOPEA
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT2006-001786-42 | None | None | None |