Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00404053
Status:
COMPLETED
Last Update Posted:
2006-11-29
First Post:
2006-11-24
Brief Title:
Clopidogrel Maintaining Dosage in Acute Coronary Syndrome After Drug Eluting Stent Implantation
Sponsor:
Shenyang Northern Hospital
Organization:
Shenyang Northern Hospital
Study Overview
Official Title:
One Year Effects of Different Clopidogrel Maintaining Dosage on Patients With Acute Coronary Syndrome Undergoing Coronary Drug Eluting Stent Implantation
Status:
COMPLETED
Status Verified Date:
2006-11
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:
In view of its safety profile and the results of clinical trials clopidogrel has become the standard treatment for patients with acute coronary syndrome ACS and drug eluting stentDES implantation Two large studies in patients with ACS shown that pretreatment with clopidogrel had beneficial effects The pretreatment regimens were given a mean of 6 days before intervention in the observational PCI-CURE trial and 3 to 24 h in the randomized CREDO trial respectively Accordingly current clinical practice carries out pretreatment with a 300mg loading dose of clopidogrel at least 6 h before DES implantation procedure in patients with ACS Compared with the 300mg clopidogrel loading dose 600mg loading dose exhibited a superior antiplatelet effect and improved short-term clinical outcomes in patients undergoing DES implantation for ACS according to recent a few publications But despite clopidogrel 600mg loading dose and the routine use of 75mg per day as a maintaining dose recurrent ischemic events occurred in some patients Therefore the goal of this study will evaluate the efficacy of a 600mg loading dose of clopidogrel plus 150mg per day as a maintaining dose in patients with ACS undergoing DES implantation
ACS patients undergoing DES implantation who receive planned 600mg loading dose clopidogrel pretreatment are eligible for the study All enrolled patients will be randomized to receive daily clopidogrel 75 mg or 150mg as maintaining doses starting as soon as post-PCI in addition to daily aspirin 100 mg and lasted for the first month after DES implantation One month later all patients receive daily clopidogrel 75mg until 912month after DES implantation The primary endpoints include death of all causes myocardial infarction revascularization of the target lesson sub-acute and late stent thrombosis one year after PCI The secondary endpoints are major and minor bleeding events The study will be powered to test the hypothesis that higher maintaining dose150mg of clopidogrel will reduce major adverse cardiac events compared to currently used common dose75 mg at one year following PCI
ACS patients undergoing DES implantation who receive planned 600mg loading dose clopidogrel pretreatment are eligible for the study All enrolled patients will be randomized to receive daily clopidogrel 75 mg or 150mg as maintaining doses starting as soon as post-PCI in addition to daily aspirin 100 mg and lasted for the first month after DES implantation One month later all patients receive daily clopidogrel 75mg until 912month after DES implantation The primary endpoints include death of all causes myocardial infarction revascularization of the target lesson sub-acute and late stent thrombosis one year after PCI The secondary endpoints are major and minor bleeding events The study will be powered to test the hypothesis that higher maintaining dose150mg of clopidogrel will reduce major adverse cardiac events compared to currently used common dose75 mg at one year following PCI
Detailed Description:
None
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