Multicentre 2x2 Factorial Randomised Study Comparing Tirofiban Versus Abciximab and SES Versus BMS in AMI
NCT00229515 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 744
Last updated 2011-10-27
Summary
The purpose of this study is to determine which from the four combinations tirofiban+sirolimus eluting stent (SES), tirofiban+bare metal stent (BMS), abciximab+SES, abciximab+BMS is the possible gold standard treatment for ST-segment elevation myocardial infarction in terms of efficacy and cost-efficacy.
Conditions
Interventions
- OTHER
-
abciximab followed by implantation of bare metal stent
Patients will receive infusion of abciximab at standard regimen before undergoing intervention for STEMI and then bare metal stent implantation in the culprit lesion
- OTHER
-
abciximab and Sirolimus eluting stent
Patients will receive abciximab infusion at standard regimen followed by implantation of sirolimus-eluting stent in the culprit lesion
- OTHER
-
tirofiban and bare metal stent
Patients will receive tirofiban infusion at high loading dose followed by standard infusion for 18-24 hours and subsequently they will be treated with bare metal stent implantation
- OTHER
-
tirofiban and sirolimus-eluting stent
Patients will receive tirofiban infusion at high loading dose followed by standard infusion for 18-24 hours and subsequently they will be treated with sirolimus-eluting stent implantation
Sponsors & Collaborators
-
Marco Valgimigli
lead OTHER
Principal Investigators
-
Roberto Ferrari, Professor · Cattedra di Cardiologia, Azienda Ospedaliera Universitaria di Ferrara, Italy
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-11-30
- Primary Completion
- 2007-04-30
- Completion
- 2012-03-31
Countries
- Italy
Study Locations
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