Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00373451
Status:
COMPLETED
Last Update Posted:
2012-05-08
First Post:
2006-09-07
Brief Title:
Randomized Comparison of Abciximab Plus Heparin With Bivalirudin in Acute Coronary Syndrome
Sponsor:
Deutsches Herzzentrum Muenchen
Organization:
Deutsches Herzzentrum Muenchen
Study Overview
Official Title:
Randomized Double-Blind Active-Controlled Multicenter Trial of Abciximab And Bivalirudin in Patients With Non-ST-Segment Elevation Myocardial Infarction Undergoing Percutaneous Coronary Interventions ISAR-REACT-4
Status:
COMPLETED
Status Verified Date:
2012-05
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:
ISAR-REACT-4
Brief Summary:
The purpose of this study is to determine which of these anti-clotting medications abciximab plus unfractionated heparin or bivalirudin is more effective to prevent thrombotic and bleeding complications in patients suffering from a heart attack and undergoing coronary intervention
Detailed Description:
Non-ST elevation myocardial infarction NSTEMI is associated with an increased risk of death and is a major reason for hospital admissions Most frequently the sequence of events that leads to NSTEMI is characterized by a disrupted atherosclerotic plaque platelet activation and aggregation thrombus formation and microembolizations Patients with NSTEMI are treated with an early invasive strategy and there is intensive work in progress to define the optimal antithrombotic therapy to be used in adjunct to percutaneous coronary intervention PCI in these patients Bivalirudin a direct thrombin inhibitor and the glycoprotein IIbIIIa inhibitor GPI abciximab have been in the focus of recent trials in patients with acute coronary syndrome ACS In a recent randomized open-label trial ACUITY trial patients with the suspicion of ACS on the basis of the type of anginal symptoms ST-segment displacement elevated biomarkers or several risk indicators were randomized to receive bivalirudin alone with bail-out GPIs bivalirudin plus GPIs or heparinlow-molecular weight heparin plus a GPI The GPIs most frequently used were eptifibatide and tirofiban Abciximab was given in only 9 of the cases In another randomized double-blind placebo-controlled trial ISAR-REACT-2 including ACS patients undergoing PCI abciximab was administered in cath lab and was associated with a significant reduction of ischemic events in patients with NSTEMI and did not lead to a measurable increase in major bleeding complications However it is not known whether abciximab is also superior to bivalirudin in patients with NSTEMI We designed this study to assess whether abciximab added to unfractionated heparin is superior to bivalirudin in patients with NSTEMI
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