Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00133003
Status:
COMPLETED
Last Update Posted:
2008-04-15
First Post:
2005-08-18
Brief Title:
Abciximab Clopidogrel and Percutaneous Coronary Intervention in Acute Coronary Syndrome ISAR-REACT-2
Sponsor:
Deutsches Herzzentrum Muenchen
Organization:
Deutsches Herzzentrum Muenchen
Study Overview
Official Title:
Prospective Randomized Double-Blind Placebo-Controlled Trial of the Glycoprotein IIbIIIa Inhibition With Abciximab in Patients With ACS Undergoing Coronary Stenting After Pretreatment With a High Loading Dose of Clopidogrel ISAR-REACT-2
Status:
COMPLETED
Status Verified Date:
2008-04
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 there is any additional benefit from abciximab administration during percutaneous coronary intervention in patients presenting with acute coronary syndromes after pre-treatment with 600mg of clopidogrel
Detailed Description:
Although percutaneous coronary interventions PCIs are an established therapeutic approach in patients presenting with acute coronary syndrome ACS it is still unclear which the best antithrombotic therapy to be applied periprocedurally is The EPISTENT trial has shown that adding abciximab a glycoprotein GP IIbIIIa receptor inhibitor to the therapy with ticlopidine plus aspirin significantly reduces the incidence of ischemic complications death myocardial infarction or reinterventions after coronary stent implantation Ticlopidine also reduces procedural complications but has a delayed onset of action after coronary stenting and has been replaced by clopidogrel which provides similar efficacy and is associated with fewer side effects Experimental studies have shown that a 600 mg loading dose of clopidogrel is safe and acts rapidly leading to a maximal inhibition of platelet aggregation within 2 hours after administration In the ISAR-REACT trial a 600 mg loading dose of clopidogrel was well tolerated and associated with such a low frequency of early complications that the use of abciximab offered no clinically measurable benefit at 30 days Although patients with ACS have frequently been treated with a cooling-off strategy for 48 hours before undergoing PCI the ISAR-COOL trial demonstrated that patients undergoing PCI within 6-12 hours of presentation with an ACS actually suffer a lower rate of ischemic complications than those for whom an invasive approach is delayed However patients with ACS represent a higher risk subset and may need a more potent antithrombotic regimen periprocedurally Therefore the results of ISAR REACT which was performed in low and intermediate risk patients should not be generalized to high risk patients
Comparison
All patients with non-ST-segment elevation acute coronary syndromes who will undergo coronary angiography willing to participate in the trial will receive a loading dose of 600 mg clopidogrel at least 2 hours prior to the procedure Eligible patients who do not meet the exclusion criteria in whom angiography reveals that PCI is planned will be randomized to receive either abciximab plus low-dose heparin 70 unitskg or high dose heparin 140 unitskg plus placebo
Comparison
All patients with non-ST-segment elevation acute coronary syndromes who will undergo coronary angiography willing to participate in the trial will receive a loading dose of 600 mg clopidogrel at least 2 hours prior to the procedure Eligible patients who do not meet the exclusion criteria in whom angiography reveals that PCI is planned will be randomized to receive either abciximab plus low-dose heparin 70 unitskg or high dose heparin 140 unitskg plus placebo
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