Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00404716
Status:
COMPLETED
Last Update Posted:
2006-11-29
First Post:
2006-11-28
Brief Title:
Triple Versus Dual Antiplatelet Therapy in Patients Undergoing Coronary Stent Implantation
Sponsor:
Shenyang Northern Hospital
Organization:
Shenyang Northern Hospital
Study Overview
Official Title:
Effects of Triple Versus Dual Antiplatelet Therapy in Patients With Acute Coronary Syndrome Undergoing Coronary 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:
Cilostazol is an kind of oral antiplatelet agent with a rapid onset of action that selectively inhibits phosphodiesterase III a mechanism different from adenosine diphosphate ADP receptor antagonists Previous studies had suggested that cilostazol has lipid-modifying and vasodilating effects in addition to antiplatelet effects From those experimental and clinical backgrounds we assumed that triple antiplatelet therapy with aspirin clopidogrel and cilostazol might have a beneficial effect on the prevention of atherothrombosis complications following coronary stenting Therefore we evaluated the safety and efficacy of triple antiplatelet regimen of aspirin clopidogrel and cilostazol compared with dual antiplatelet regimen of aspirin and clopidogrel in patients with acute coronary syndrome undergoing successful coronary artery stenting
Patients undergoing successful coronary stenting were divided into dual antiplatelet therapy aspirin plus clopidogrel and triple antiplatelet therapy aspirin and clopidogrel plus cilostazol groups All enrolled patients in triple regimen group will receive cilostazol 100mg bid for 6 months in addition to standard dose and duration of aspirin and clopidogrel for post-PCI The primary endpoints included death myocardial infarction target lesion revascularization stent thrombosis within 30 days binary restenosis at six month and major adverse cardiac events MACE at one year The secondary endpoints were side effects of study drugs including major bleeding vascular complication hypersensitivebility and bleeding complications The study will be powered to test the hypothesis that triple antiplatelet therapy is better than dual antiplatelet therapy
Patients undergoing successful coronary stenting were divided into dual antiplatelet therapy aspirin plus clopidogrel and triple antiplatelet therapy aspirin and clopidogrel plus cilostazol groups All enrolled patients in triple regimen group will receive cilostazol 100mg bid for 6 months in addition to standard dose and duration of aspirin and clopidogrel for post-PCI The primary endpoints included death myocardial infarction target lesion revascularization stent thrombosis within 30 days binary restenosis at six month and major adverse cardiac events MACE at one year The secondary endpoints were side effects of study drugs including major bleeding vascular complication hypersensitivebility and bleeding complications The study will be powered to test the hypothesis that triple antiplatelet therapy is better than dual antiplatelet therapy
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