Ignite Creation Date:
2024-05-05 @ 9:32 PM
Last Modification Date:
2024-10-26 @ 10:06 AM
Study NCT ID:
NCT00910065
Status:
COMPLETED
Last Update Posted:
2015-06-25
First Post:
2009-05-28
Brief Title:
BAY81-8781 IV Aspirin in the Indication of Acute Coronary Syndrome ACS
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
A Prospective Randomized Verum Controlled Open Label Parallel Group Multi-center Phase III Clinical Trial to Demonstrate the Superiority of 500 or 250 mg Aspirin iv BAY 81-8781 Treatment Versus 300 mg Aspirin N Tablets po BAY e4465A in Patients With Acute Coronary Syndrome Measured by Time Dependent Thromboxane Inhibition
Status:
COMPLETED
Status Verified Date:
2015-06
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:
ACUTE
Brief Summary:
The objective of this study is to investigate whether intravenous administration injected into a vein of acetylsalicylic acid Aspirin in doses of 250 and 500 mg is superior to oral treatment of ACS with tablets containing 300 mg of Aspirin
Detailed Description:
In November 2009 it was the companys decision to cancel this study as an international trial However to support the local MA application of Aspirin iv for the indication For the initial treatment in case of suspicion of acute coronary syndrome Bayer decided to perform this trial in Germany as a domestic trial with changed number of participants and study dates
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 |
|---|---|---|---|
| 2007-005163-94 | EUDRACT_NUMBER | None | None |