Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00229515
Status:
UNKNOWN
Last Update Posted:
2011-10-27
First Post:
2005-09-27
Brief Title:
Multicentre 2x2 Factorial Randomised Study Comparing Tirofiban Versus Abciximab and SES Versus BMS in AMI
Sponsor:
Marco Valgimigli
Organization:
Università degli Studi di Ferrara
Study Overview
Official Title:
Multicentre 2x2 Factorial Randomised Study Comparing Tirofiban Administered With the Single High-Dose Bolus Versus Abciximab and Sirolimus Eluting Stent Versus Bare Metal Stent in Acute Myocardial Infarction - MULTI-STRATEGY Trial
Status:
UNKNOWN
Status Verified Date:
2011-10
Last Known Status:
ACTIVE_NOT_RECRUITING
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 purpose of this study is to determine which from the four combinations tirofibansirolimus eluting stent SES tirofibanbare metal stent BMS abciximabSES abciximabBMS is the possible gold standard treatment for ST-segment elevation myocardial infarction in terms of efficacy and cost-efficacy
Detailed Description:
The combination abciximab plus bare metal stent BMS is currently considered the standard therapy for AMI The use of sirolimus eluting stent SES is related to a reduction of the need for urgent target vessel revascularization TVR With current acquisition prices for abciximab and SES replacing abciximab with tirofiban administered as a single high-dose bolus SHDB regimen is a promising strategy that would preserve financial resources In a recent study the combination tirofiban and SES resulted to be associated to an overall lower major adverse cardiovascular events MACE rate with respect to the abciximab plus BMS However since no conclusion can be drawn yet regarding the relative contribution of a specific GP IIbIIIa inhibitor or a stent type with respect to the other the combination of abciximab and SES may be associated to an even lower event rate with respect to SHDB tirofiban and SES thus offsetting the higher initial cost
Comparisons four strategies SHDB tirofiban BMS SHDB tirofiban SES abciximab BMS abciximab SES are compared to determine the possible gold standard treatment for ST-segment elevation myocardial infarction in terms of efficacy and cost-efficacy
Comparisons four strategies SHDB tirofiban BMS SHDB tirofiban SES abciximab BMS abciximab SES are compared to determine the possible gold standard treatment for ST-segment elevation myocardial infarction in terms of efficacy and cost-efficacy
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