Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00093158
Status:
COMPLETED
Last Update Posted:
2007-08-21
First Post:
2004-10-04
Brief Title:
Comparison of Angiomax Versus Heparin in Acute Coronary Syndromes ACS
Sponsor:
The Medicines Company
Organization:
The Medicines Company
Study Overview
Official Title:
The ACUITY Trial A Randomized Comparison of Angiomax Bivalirudin Versus Heparin Unfractionated Heparin or Enoxaparin in Patients Undergoing Early Invasive Management for Acute Coronary Syndromes Without ST-Segment Elevation
Status:
COMPLETED
Status Verified Date:
2007-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to show that when compared with heparin enoxaparin or unfractionated heparin and routine GPIIbIIIa inhibition either started upfront or at the time of percutaneous coronary intervention PCI Arm A
1 Bivalirudin with routine GPIIbIIIa inhibition either started upfront or at the time of PCI Arm B provides non-inferior or superior overall clinical outcomes and
2 Bivalirudin alone Arm C reduces clinically significant bleeding An important secondary objective for this comparison is to show that bivalirudin is not inferior for ischemic complications
1 Bivalirudin with routine GPIIbIIIa inhibition either started upfront or at the time of PCI Arm B provides non-inferior or superior overall clinical outcomes and
2 Bivalirudin alone Arm C reduces clinically significant bleeding An important secondary objective for this comparison is to show that bivalirudin is not inferior for ischemic complications
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 |
|---|---|---|---|
| ACUITY | None | None | None |