Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00222261
Status:
COMPLETED
Last Update Posted:
2011-03-23
First Post:
2005-09-13
Brief Title:
Aspirin Non-responsiveness and Clopidogrel Endpoint Trial
Sponsor:
Ullevaal University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Aspirin Non-responsiveness and Clopidogrel Endpoint Trial
Status:
COMPLETED
Status Verified Date:
2011-03
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:
ASCET
Brief Summary:
In the ASCET study 1000 patients with documented coronary heart disease will be randomized to either continued treatment with aspirin 160 mgd or change to clopidogrel 75mgd Clinical endpoints will be recorded for at least 2 years and related to the initial aspirin response assessed by the PFA-100 method to investigate whether aspirin non-responders have higher composite event rate than responders or whether Clopidogrel treatment in patients non-responsive to aspirin will reduce their risk of future clinical events The clinical events are the composite of unstable angina myocardial infarction stroke or death
Detailed Description:
Background Aspirin is widely used as an antiplatelet drug in patients with coronary heart disease Despite documented clinical benefit many patients on aspirin still experience severe cardiovascular events Several laboratory reports have shown lack of platelet inhibition in 5-40 of aspirin-treated patients and the term aspirin resistance has been introduced The clinical relevance of these laboratory findings is however still unknown New antiplatelet drugs have been developed and the adenosin diphosphate ADP receptor inhibitor clopidogrel has at least the same efficacy as aspirin with an acceptable safety profile Laboratory methods for determination of platelet reactivity and treatment efficacy have been complicated and time consuming New methodologies like the PFA-100 system have made such analyses more suitable for clinical use
Design In the ASCET study 1000 patients with documented coronary heart disease will be randomized to either continued treatment with aspirin 160 mgd or change to clopidogrel 75mgd after initial determination of their platelet reactivity while on aspirin treatment Clinical endpoints will be recorded for at least 2 years and related to the initial aspirin response
Scand Cardiovasc J 2004 Dec386353-6
Design In the ASCET study 1000 patients with documented coronary heart disease will be randomized to either continued treatment with aspirin 160 mgd or change to clopidogrel 75mgd after initial determination of their platelet reactivity while on aspirin treatment Clinical endpoints will be recorded for at least 2 years and related to the initial aspirin response
Scand Cardiovasc J 2004 Dec386353-6
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