Ignite Creation Date:
2024-05-06 @ 12:01 AM
Last Modification Date:
2024-10-26 @ 10:42 AM
Study NCT ID:
NCT01463150
Status:
COMPLETED
Last Update Posted:
2012-07-11
First Post:
2011-10-27
Brief Title:
Prasugrel 5mg Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Aged 75 Years andor Weighing 60 kg Post Percutaneous Coronary Intervention PCI
Sponsor:
University of Patras
Organization:
University of Patras
Study Overview
Official Title:
Prasugrel 5mg Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Aged 75 Years andor Weighing 60 kg Post Percutaneous Coronary Intervention PCI
Status:
COMPLETED
Status Verified Date:
2012-04
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 use of dual antiplatelet therapy is considered standard of care in patients post percutaneous coronary intervention PCI with stenting However a significant proportion of patients is considered clopidogrel resistant and this resistance is shown to be accompanied by future adverse events The aim of the study is to define in consecutive patients with acute coronary syndrome ACS undergoing PCI those aged75years andor weighted60 Kg with high on-clopidogrel platelet reactivity Platelet Reactivity Units-PRU235 as estimated 24 hours post PCI with the VerifyNow assay Those patients will be randomized after informed concent in 11 fashion to prasugrel 5 mg or clopidogrel 150mg daily Platelet reactivity will be assessed at day 15 and then treatment crossover will be performed At day 30 platelet reactivity will be determined as well
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