| September 27, 2005 |
| January 9, 2008 |
| November 2004 |
| April 2007 (final data collection date for primary outcome measure) |
- The evaluation of the degree of ST-segment resolution after the mechanical intervention. [ Time Frame: 90 minutes after last balloon inflation ] [ Designated as safety issue: No ]
- The cumulative rate of death for any cause, reinfarction and target vessel revascularisation [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
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- The evaluation of the degree of ST-segment resolution obtained immediately after the mechanical intervention at randomisation.
- The incidence of the composite of death, nonfatal AMI, stroke and clinically-driven target vessel revascularization at 8 months.
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| Complete list of historical versions of study NCT00229515 on ClinicalTrials.gov Archive Site |
- Death, recurrent acute myocardial infarction, target vessel revascularization and target lesion revascularisation, considered separately or in combination. [ Time Frame: at any time during follow-up ] [ Designated as safety issue: Yes ]
- The evaluation of the cost-effectiveness of the involved experimental treatments. [ Time Frame: 8 months, 1,3 and 5 years ] [ Designated as safety issue: No ]
- stent thrombosis according to the ARC classification [ Time Frame: any time during follow-up ] [ Designated as safety issue: Yes ]
- the degree of cumulative or single lead ST segment resolution at time frames different from the primary endpoint. the degree of residual ST segment elevation. [ Time Frame: immediately after intervention, at 90 minutes and at discharge ] [ Designated as safety issue: No ]
- bleeding rate defined according to different classifications including TIMI, Acuity, GUSTO and Steeple. [ Time Frame: at 30 days, 1 year, 3 and 5 years ] [ Designated as safety issue: Yes ]
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- Death, recurrent acute myocardial infarction, target vessel revascularization and target lesion revascularisation, considered separately or in combination, at 30 days, 4 months, 8 months, 1 and 3 years.
- The evaluation of the cost-effectiveness of the involved treatments at 30 days, 4 months, 8 months, 1 and 3 years.
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| Multicentre 2x2 Factorial Randomised Study Comparing Tirofiban Versus Abciximab and SES Versus BMS in AMI |
| 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 |
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. |
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 IIb/IIIa 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.
Comparison(s): 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. |
| Phase IV |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study |
| Myocardial Infarction |
- Other: abciximab followed by implantation of bare metal stent
- Other: abciximab and Sirolimus eluting stent
- Other: tirofiban and bare metal stent
- Other: tirofiban and sirolimus-eluting stent
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- Active Comparator: Patients will receive abciximab infusion at standard regimen prior undergoing percutaneous coronary intervention for STEMI followed by BMS implantation in the culprit lesion
- Experimental: Abciximab followed by implantation of sirolimus-eluting stent in the culprit lesion
- Experimental: tirofiban infusion followed by bare metal stent implantation
- Experimental: tirofiban and sirolimus-eluting stent
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- Valgimigli M, Percoco G, Malagutti P, Campo G, Ferrari F, Barbieri D, Cicchitelli G, McFadden EP, Merlini F, Ansani L, Guardigli G, Bettini A, Parrinello G, Boersma E, Ferrari R; STRATEGY Investigators. Tirofiban and sirolimus-eluting stent vs abciximab and bare-metal stent for acute myocardial infarction: a randomized trial. JAMA. 2005 May 4;293(17):2109-17.
- Valgimigli M, Campo G, Percoco G, Bolognese L, Vassanelli C, Colangelo S, de Cesare N, Rodriguez AE, Ferrario M, Moreno R, Piva T, Sheiban I, Pasquetto G, Prati F, Nazzaro MS, Parrinello G, Ferrari R; Multicentre Evaluation of Single High-Dose Bolus Tirofiban vs Abciximab With Sirolimus-Eluting Stent or Bare Metal Stent in Acute Myocardial Infarction Study (MULTISTRATEGY) Investigators. Comparison of angioplasty with infusion of tirofiban or abciximab and with implantation of sirolimus-eluting or uncoated stents for acute myocardial infarction: the MULTISTRATEGY randomized trial. JAMA. 2008 Apr 16;299(15):1788-99. Epub 2008 Mar 30.
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| |
| Active, not recruiting |
| 744 |
| March 2012 |
| April 2007 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- ST segment elevation myocardial infarction
- Schedule for primary percutaneous coronary intervention
- Informed consent
Exclusion Criteria:
- Administration of fibrinolytic or any GP IIb/IIIa inhibitors for the treatment of current acute myocardial infarction or within 1 month before it
- History of bleeding diathesis or allergy to the studies drug
- Major surgery within 30 days
- Limited life expectancy, e.g. neoplasms, others
- Pregnancy
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| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Italy |
| |
| NCT00229515 |
| Marco Valgimigli, Azienda Ospedaliera Universitaria di Ferrara |
| TSES-02-III |
| Universitaria di Ferrara |
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| Study Chair: |
Roberto Ferrari, Professor |
Cattedra di Cardiologia, Azienda Ospedaliera Universitaria di Ferrara, Italy |
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| Universitaria di Ferrara |
| December 2007 |