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Multicentre 2x2 Factorial Randomised Study Comparing Tirofiban Versus Abciximab and SES Versus BMS in AMI

M

Marco Valgimigli

Status and phase

Unknown
Phase 4

Conditions

Myocardial Infarction

Treatments

Other: abciximab and Sirolimus eluting stent
Other: tirofiban and bare metal stent
Other: abciximab followed by implantation of bare metal stent
Other: tirofiban and sirolimus-eluting stent

Study type

Interventional

Funder types

Other

Identifiers

NCT00229515
TSES-02-III

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

744 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

744 participants in 4 patient groups

1
Active Comparator group
Description:
Patients will receive abciximab infusion at standard regimen prior undergoing percutaneous coronary intervention for STEMI followed by BMS implantation in the culprit lesion
Treatment:
Other: abciximab followed by implantation of bare metal stent
2
Experimental group
Description:
Abciximab followed by implantation of sirolimus-eluting stent in the culprit lesion
Treatment:
Other: abciximab and Sirolimus eluting stent
3
Experimental group
Description:
tirofiban infusion followed by bare metal stent implantation
Treatment:
Other: tirofiban and bare metal stent
4
Experimental group
Description:
tirofiban and sirolimus-eluting stent
Treatment:
Other: tirofiban and sirolimus-eluting stent

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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