Ignite Creation Date:
2024-05-06 @ 1:23 AM
Last Modification Date:
2024-10-26 @ 11:03 AM
Study NCT ID:
NCT01790854
Status:
TERMINATED
Last Update Posted:
2016-07-29
First Post:
2013-02-12
Brief Title:
BLeeding Events and Maintenance DoSe of PraSugrel
Sponsor:
David Antoniucci
Organization:
Careggi Hospital
Study Overview
Official Title:
Bless Study BLeeding Events and Maintenance DoSe of PraSugrel
Status:
TERMINATED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low events rate Scarce economical resources
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BLESS
Brief Summary:
Aim to verify if after the acute phase of ACS acute coronary syndrome 1-months from 1 to 12 months the reduction of maintenance dose of prasugrel from 10 mg to 5 mgday may reduce the bleeding events 5 mg vs 10 mg All patients will be treated with 325 mg of aspirin followed by a maintenance dosage of 100 mg of aspirin for at least 1 year At baseline after 60 mg loading dose of prasugrel and after 1 month 7 days after the randomization at 10 or 5 mg of prasugrel all patients will undergo light transmittance aggregometry LTA test to evaluate residual platelet reactivity pharmacodynamic effects
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