Ignite Creation Date:
2024-05-06 @ 12:34 AM
Last Modification Date:
2024-10-26 @ 10:52 AM
Study NCT ID:
NCT01609647
Status:
COMPLETED
Last Update Posted:
2014-12-23
First Post:
2012-05-29
Brief Title:
Reloading Prasugrel or Clopidogrel on High Platelet Reactivity Before Percutaneous Coronary Intervention
Sponsor:
Dong-A University
Organization:
Dong-A University
Study Overview
Official Title:
Comparison of Prasugrel and Clopidogrel Reloading on High Platelet Reactivity in Clopidogrel-loaded Patients Undergoing Percutaneous Coronary Intervention
Status:
COMPLETED
Status Verified Date:
2014-12
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:
PRAISE-HPR
Brief Summary:
High platelet reactivity unit PRU after loading dose clopidogrel in patients undergoing percutaneous coronary intervention PCI is related to high risk of short and long term recurrent ischemic events including stent thrombosis
The investigators hypothesize that additional loading of prasugrel in patients with high PRU after clopidogrel loading would be superior to additional loading of clopidogrel in reducing platelet reactivity and thereby result in lower risk of short term recurrent ischemic events
The investigators hypothesize that additional loading of prasugrel in patients with high PRU after clopidogrel loading would be superior to additional loading of clopidogrel in reducing platelet reactivity and thereby result in lower risk of short term recurrent ischemic events
Detailed Description:
Dual antiplatelet therapy with acetylsalicyclic acid ASA and additional clopidogrel is now standard regimen for the prevention of recurrent ischemic events in patients who undergo PCI
But decreased effect of clopidogrel in a group of patients was reported and they are known to be associated with high risk of recurrent ischemic event Decreased effect of clopidogrel is mainly resulted from decreased function to metabolite prodrug clopidogrel to active form of drug
Prasugrel newer thienopyridine has been recently developed and showed advantages to clopidogrel Prasugrel is known to have shorter onset time to achieve steady state level than clopidogrel and constant pharmacologic effect regardless of patient diversity
High PRU after loading dose clopidogrel in patients undergoing PCI is known to be related to increased risk of short and long term recurrent ischemic events including stent thrombosis Prasugrel has been reported to be effective in reducing platelet reactivity in patients showing resistance to clopidogrel and high PRU
The investigators hypothesize that additional loading of prasugrel in patients with high PRU after clopidogrel loading would be superior to additional loading of clopidogrel in reducing platelet reactivity and thereby result in reduced risk of short term recurrent ischemic events
The investigators plan to include 70 acute coronary syndrome patients who are planned to undergo PCI and show high platelet reactivity Most patients with ACS administer loading dose of ASA and clopidogrel as soon as they are assumed to be ACS
The investigators plan to perform platelet reactivity test by VeryfyNow VN before PCI and enroll patients with high PRU defined by 235 or more They are to randomly administered additional 300mg of clopidogrel or 20mg of prasugrel
But decreased effect of clopidogrel in a group of patients was reported and they are known to be associated with high risk of recurrent ischemic event Decreased effect of clopidogrel is mainly resulted from decreased function to metabolite prodrug clopidogrel to active form of drug
Prasugrel newer thienopyridine has been recently developed and showed advantages to clopidogrel Prasugrel is known to have shorter onset time to achieve steady state level than clopidogrel and constant pharmacologic effect regardless of patient diversity
High PRU after loading dose clopidogrel in patients undergoing PCI is known to be related to increased risk of short and long term recurrent ischemic events including stent thrombosis Prasugrel has been reported to be effective in reducing platelet reactivity in patients showing resistance to clopidogrel and high PRU
The investigators hypothesize that additional loading of prasugrel in patients with high PRU after clopidogrel loading would be superior to additional loading of clopidogrel in reducing platelet reactivity and thereby result in reduced risk of short term recurrent ischemic events
The investigators plan to include 70 acute coronary syndrome patients who are planned to undergo PCI and show high platelet reactivity Most patients with ACS administer loading dose of ASA and clopidogrel as soon as they are assumed to be ACS
The investigators plan to perform platelet reactivity test by VeryfyNow VN before PCI and enroll patients with high PRU defined by 235 or more They are to randomly administered additional 300mg of clopidogrel or 20mg of prasugrel
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