Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00398463
Status:
COMPLETED
Last Update Posted:
2011-07-01
First Post:
2006-11-09
Brief Title:
Study of Tirofiban Administration in Patients With Aspirin and or Clopidogrel Resistance
Sponsor:
Università degli Studi di Ferrara
Organization:
Università degli Studi di Ferrara
Study Overview
Official Title:
Tailoring Treatment With Tirofiban in Patients Showing Resistance to Aspirin andor Resistance to Clopidogrel
Status:
COMPLETED
Status Verified Date:
2008-06
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:
3T2R
Brief Summary:
This study will evaluate whether adding tirofiban administered at high bolus dose on top of aspirin and clopidogrel will lead to a lower rate of periprocedural myocardial infarction after percutaneous coronary intervention in elective patients presenting with aspirin andor clopidogrel resistance
Detailed Description:
This study will investigate the effect of treatment with a high bolus dosage of Tirofiban in addition to Aspirin Heparin and 300mg or 600mg clopidogrel on the rate of periprocedural myocardial infarction compared to Aspirin Heparin or bivalirudin and 300mg or 600mg clopidogrel alone in patients resistant to aspirin andor to clopidogrel
This is a randomized double blind placebo controlled with bailout tirofiban as rescue multicenter study Enrollment will last between 12 and 36 months depending on the final number of participating centres The minimum follow-up will be 30 days after the index procedure
This is a randomized double blind placebo controlled with bailout tirofiban as rescue multicenter study Enrollment will last between 12 and 36 months depending on the final number of participating centres The minimum follow-up will be 30 days after the index procedure
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