Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00262054
Status:
COMPLETED
Last Update Posted:
2010-03-15
First Post:
2005-12-05
Brief Title:
Un-fractionated Heparin Versus Bivalirudin During Percutaneous Coronary Interventions PCI ISAR-REACT-3
Sponsor:
Deutsches Herzzentrum Muenchen
Organization:
Deutsches Herzzentrum Muenchen
Study Overview
Official Title:
Prospective Randomized Double-Blind Active-Controlled Multicenter Trial of Bivalirudin and Un-fractionated Heparin in Patients Undergoing Percutaneous Coronary Interventions ISAR-REACT-3
Status:
COMPLETED
Status Verified Date:
2008-08
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:
The purpose of this study is to determine whether bivalirudin given during PCI is associated with better outcomes compared to un-fractionated heparin
Detailed Description:
Thrombin plays a major role in acute coronary artery occlusions during percutaneous coronary interventions Unfractionated heparin has been traditionally used during invasive coronary procedures to reduce the risk of thrombotic occlusion Bivalirudin a direct antithrombin inhibitor has several advantages over unfractionated heparin it acts independently of antithrombin and inhibits both free and clot-bound thrombin it is not neutralized by circulating inhibitors exhibits consistent dose-response characteristics and does not cause thrombocytopenia Previous studies have shown that use of bivalirudin among patients undergoing percutaneous coronary interventions is associated with better outcomes death myocardial infarction urgent repeat revascularization or in-hospital major bleeding as compared with unfractionated heparin and adjunctive use of glycoprotein IIbIIIa platelet receptor inhibitors However previous studies have included patients treated with plain balloon angioplasty or stenting after inadequate pre-treatment with thienopyridines ticlopidine or clopidogrel Recent guidelines recommend that all patients undergoing percutaneous coronary interventions must receive a loading dose of 300 -600 mg of clopidogrel A 600 mg loading dose of clopidogrel eliminates the need for glycoprotein IIbIIIa platelet receptor inhibitors in adjunct to heparin According to existing evidence antithrombotic regimens based on either bivalirudin or pre-treatment with 600 mg of clopidogrel in addition to UFH intraprocedurally are effective strategies to reduce ischemic and hemorrhagic complications in patients with coronary artery disease undergoing PCI At present it is not known whether bivalirudin is superior to UHF in patients who have been optimally pre-treated with a loading dose of clopidogrel
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 |
|---|---|---|---|
| KKF 11-05 | None | None | None |