Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00444132
Status:
COMPLETED
Last Update Posted:
2007-09-20
First Post:
2007-03-06
Brief Title:
Clopidogrel Reloading in Clopidogrel Resistant Patients With ACS
Sponsor:
Sheba Medical Center
Organization:
Sheba Medical Center
Study Overview
Official Title:
Clopidogrel Reloading in Clopidogrel Resistant Patients With ACS
Status:
COMPLETED
Status Verified Date:
2007-09
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:
Laboratory clopidogrel resistance is associated with adverse atherothrombotic events in patients with coronary artery disease In the proposed study we wish to prospectively assess the effect of reloading with 600 mg clopidogrel and administer maintenance treatment with clopidogrel 150 mgday for one month in a group of acute myocardial infarction AMI patients who demonstrate non-responsiveness to clopidogrel
Detailed Description:
Prior studies have demonstrated significant variability in platelet response to clopidogrel in patients with coronary artery disease CAD Up to 25 of patients have been shown to be non-responders to a conventional dose of clopidogrel This phenomenon has been associated with higher incidence of recurrent cardiovascular CVS adverse events in patients with acute coronary syndrome ACS and higher incidence of peri-procedural myocardial damage thrombotic complications and ischemic events in patients undergoing elective percutaneous coronary intervention PCI Both the ex-vivo anti-platelet effect and the clinical benefit of clopidogrel are dose related Moreover in patients sustaining ACS while on maintenance clopidogrel treatment reloading with 600 mg clopidogrel resulted in further reduction in platelet aggregation although the patients were not non-responders Despite this the effect of dose escalation has never been examined in patients resistant to clopidogrel In the present study we wish to assess prospectively the effect of reloading with 600 mg clopidogrel and double dose maintenance treatment 150 mgday for one month in acute myocardial infarction AMI patients who demonstrate non-respondese to 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