Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00070655
Status:
COMPLETED
Last Update Posted:
2011-04-06
First Post:
2003-10-06
Brief Title:
Evaluating the Use of SR34006 Compared to Warfarin or Acenocoumarol in Patients With Atrial Fibrillation AMADEUS
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
The AMADEUS Trial A Multicenter Randomized Open-label Assessor Blind Non-inferiority Study Comparing the Efficacy and Safety of Once-weekly Subcutaneous Idraparinux SR34006 With Adjusted-dose Oral Vitamin-K Antagonists in the Prevention of Thromboembolic Events in Patients With Atrial Fibrillation
Status:
COMPLETED
Status Verified Date:
2011-04
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:
None
Brief Summary:
This trial will include patients who have a heart condition called atrial fibrillation Atrial fibrillation is an abnormal rhythm irregular beat in the heart Patients with atrial fibrillation have an increased chance for a blood clot to form in the heart and move to other blood vessels in the body and cause obstruction This obstruction may damage tissue For example a blood clot plugging a vessel in the brain could cause a stroke Therefore patients with atrial fibrillation may be given anticoagulant blood-thinning tablets such as warfarin or acenocoumarol
The purpose of this study is to compare the safety and effectiveness of a new injectable anticoagulant drug that is administered once weekly SR34006 with warfarin or acenocoumarol tablets
Assignment to either SR34006 Injection or vitamin K antagonist warfarin or acenocoumarol tablets will be purely by chance and will be known by both patients and their doctors
The purpose of this study is to compare the safety and effectiveness of a new injectable anticoagulant drug that is administered once weekly SR34006 with warfarin or acenocoumarol tablets
Assignment to either SR34006 Injection or vitamin K antagonist warfarin or acenocoumarol tablets will be purely by chance and will be known by both patients and their doctors
Detailed Description:
None
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 |
|---|---|---|---|
| SR34006 | None | None | None |