Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00043940
Status:
COMPLETED
Last Update Posted:
2011-09-16
First Post:
2002-08-14
Brief Title:
Anticoagulant Therapy With Bivalirudin in the Performance of Percutaneous Coronary Intervention in Patients With Heparin-Induced Thrombocytopenia AT BAT First Inning
Sponsor:
The Medicines Company
Organization:
The Medicines Company
Study Overview
Official Title:
Anticoagulant Therapy With Bivalirudin in the Performance of PCI in Patients With Heparin-Induced Thrombocytopenia
Status:
COMPLETED
Status Verified Date:
2011-09
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:
Primary Objective
To assess the safety of bivalirudin as an alternative anticoagulant therapy for patients with new or previous heparin-induced thrombocytopenia HIT heparin-induced thrombocytopenia and thrombosis syndrome HITTS undergoing percutaneous coronary intervention PCI This will be measured by the composite incidence of major bleeding events during administration or within 48 hours after stopping bivalirudin or at hospital discharge whichever occurs first The components of the composite endpoint are a intracranial bleeding b retroperitoneal bleeding c bleeding that results in hemodynamic compromise d bleeding that requires transfusion of three or more units of whole blood or packed red cells and e a decrease in hemoglobin of greater than or equal to gdL or in hematocrit of greater than or equal to 9
Secondary Objectives
Each component of the primary composite endpoint
To evaluate the level of anticoagulation achieved with bivalirudin The goal is to achieve an activated clotting time ACT between 300 and 350 sec during PCI and 4-hour bivalirudin infusion
To evaluate bivalirudins effects on platelet counts
To assess the safety of bivalirudin as an alternative anticoagulant therapy for patients with new or previous heparin-induced thrombocytopenia HIT heparin-induced thrombocytopenia and thrombosis syndrome HITTS undergoing percutaneous coronary intervention PCI This will be measured by the composite incidence of major bleeding events during administration or within 48 hours after stopping bivalirudin or at hospital discharge whichever occurs first The components of the composite endpoint are a intracranial bleeding b retroperitoneal bleeding c bleeding that results in hemodynamic compromise d bleeding that requires transfusion of three or more units of whole blood or packed red cells and e a decrease in hemoglobin of greater than or equal to gdL or in hematocrit of greater than or equal to 9
Secondary Objectives
Each component of the primary composite endpoint
To evaluate the level of anticoagulation achieved with bivalirudin The goal is to achieve an activated clotting time ACT between 300 and 350 sec during PCI and 4-hour bivalirudin infusion
To evaluate bivalirudins effects on platelet counts
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