Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00133250
Status:
COMPLETED
Last Update Posted:
2010-03-16
First Post:
2005-08-20
Brief Title:
Value of Abciximab in Patients With AMI Undergoing Primary PCI After Clopidogrel Pretreatment BRAVE 3
Sponsor:
Deutsches Herzzentrum Muenchen
Organization:
Deutsches Herzzentrum Muenchen
Study Overview
Official Title:
Value of Abciximab in Patients With AMI Undergoing PCI After High Dose Clopidogrel Pretreatment BRAVE 3
Status:
COMPLETED
Status Verified Date:
2010-03
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 assess whether abciximab is associated with additional benefit in patients with AMI treated with PCI after high dose clopidogrel loading
Detailed Description:
The goal of all reperfusion therapies in acute myocardial infarction AMI is an effective restoration of coronary blood flow and the reduction of infarct size Recently the researchers were able to achieve excellent results with primary stenting plus abciximab in terms of reduction of infarct size and improvement of clinical outcome in the STOPAMI trial This strategy provided a clear benefit compared to fibrinolysis On the basis of the data published in the last 2 years hospitals without angioplasty facilities have now better possibilities to improve the results of primary treatment of patients with AMI by immediately referring these patients to highly experienced centers in coronary interventions There is an increasing interest to assess the additional advantages of pharmacologic reperfusion approaches which are readily applicable in the time window between presentation and arrival at the catheterization room Two studies have shown that the results of the PCI in patients with AMI pretreated with fibrinolysis may even be more unfavorable than those achieved with angioplasty alone Glycoprotein GP IIbIIIa blocker abciximab has been shown to improve the results of the primary PCI in AMI However no rapidly effective antiplatelets therapy was available at the time when the studies on the benefit of abciximab were performed Recent studies have shown that a high 600 mg loading dose of clopidogrel is significantly more rapidly acting and that maximal inhibition of platelet aggregation is achieved within 2 hours after administration In the ISAR-REACT trial a high loading dose of clopidogrel was well tolerated associated with such a low frequency of procedural complications that the use of abciximab offered no clinically measurable benefit at 30 days
Comparison
Abciximab bolusinfusion for 12h versus Placebo bolusinfusion for 12h after pre-treatment with 600 mg clopidogrel
Comparison
Abciximab bolusinfusion for 12h versus Placebo bolusinfusion for 12h after pre-treatment with 600 mg 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