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AzTrials

Myocardial InfarctionPhase 4NCT00229515

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

A Phase 4 study testing abciximab followed by implantation of bare metal stent, abciximab and Sirolimus eluting stent and tirofiban and bare metal stent in people with Myocardial Infarction, run by Marco Valgimigli at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myocardial Infarction
What is being tested?
abciximab followed by implantation of bare metal stent, abciximab and Sirolimus eluting stent and tirofiban and bare metal stent
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
744 participants
Where
1 siteItaly
Study dates
Nov 2004to Mar 2012
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ST segment elevation myocardial infarction
  • Schedule for primary percutaneous coronary intervention
  • Informed consent

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Italy1 site

  • Cattedra di Cardiologia, Azienda Ospedaliera Universitaria di Ferrara

    Ferrara, 44100

Other trials in Italy

About this study

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

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.

Read the 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 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.

Being tested
abciximab followed by implantation of bare metal stent, abciximab and Sirolimus eluting stent, tirofiban and bare metal stent, tirofiban and sirolimus-eluting stent
Keywords
Myocardial infarction, Revascularization, Stent, ST segment elevation
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • abciximab followed by implantation of bare metal stentOther

    Also called Glycoprotein IIB/IIIa inhibitors, 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

  • abciximab and Sirolimus eluting stentOther

    Also called glycoprotein IIb/IIIa inhibitors, stent, DES, drug-eluting stent

    Patients will receive abciximab infusion at standard regimen followed by implantation of sirolimus-eluting stent in the culprit lesion

  • tirofiban and bare metal stentOther

    Also called glycoprotein IIb/IIIa inhibitors, stent, uncoated stent, 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

  • tirofiban and sirolimus-eluting stentOther

    Also called glycoprotein IIb/IIIa inhibitors, stent, drug-eluting stent, 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

Study groups in NCT00229515
Study groupRoleWhat they receive
1Active comparatorPatients will receive abciximab infusion at standard regimen prior undergoing percutaneous coronary intervention for STEMI followed by BMS implantation in the culprit lesion
Receives: Other: abciximab followed by implantation of bare metal stent
2ExperimentalAbciximab followed by implantation of sirolimus-eluting stent in the culprit lesion
Receives: Other: abciximab and Sirolimus eluting stent
3Experimentaltirofiban infusion followed by bare metal stent implantation
Receives: Other: tirofiban and bare metal stent
4Experimentaltirofiban and sirolimus-eluting stent
Receives: Other: tirofiban and sirolimus-eluting stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The evaluation of the degree of ST-segment resolution after the mechanical intervention.

    Measured: 90 minutes after last balloon inflation

  2. The cumulative rate of death for any cause, reinfarction and target vessel revascularisation

    Measured: 8 months

Secondary outcomes (5)

  1. Death, recurrent acute myocardial infarction, target vessel revascularization and target lesion revascularisation, considered separately or in combination.

    Measured: at any time during follow-up

  2. The evaluation of the cost-effectiveness of the involved experimental treatments.

    Measured: 8 months, 1,3 and 5 years

  3. stent thrombosis according to the ARC classification

    Measured: any time during follow-up

  4. 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.

    Measured: immediately after intervention, at 90 minutes and at discharge

  5. bleeding rate defined according to different classifications including TIMI, Acuity, GUSTO and Steeple.

    Measured: at 30 days, 1 year, 3 and 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2005 (estimated)
  2. Study startNov 2004
  3. Primary completionApr 2007
  4. Study completionMar 2012 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
744 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00229515
Sponsor's protocol ID
TSES-02-III
Status last verified
Oct 2011
First submitted
27 Sep 2005
Last updated
27 Oct 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • 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. doi: 10.1001/jama.293.17.2109.

    PubMed 15870414

  • Garg S, Sarno G, Serruys PW, Rodriguez AE, Bolognese L, Anselmi M, De Cesare N, Colangelo S, Moreno R, Gambetti S, Monti M, Bristot L, Bressers M, Garcia-Garcia HM, Parrinello G, Campo G, Valgimigli M; STRATEGY and MULTISTRATEGY Investigators. Prediction of 1-year clinical outcomes using the SYNTAX score in patients with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention: a substudy of the STRATEGY (Single High-Dose Bolus Tirofiban and Sirolimus-Eluting Stent Versus Abciximab and Bare-Metal Stent in Acute Myocardial Infarction) and MULTISTRATEGY (Multicenter Evaluation of Single High-Dose Bolus Tirofiban Versus Abciximab With Sirolimus-Eluting Stent or Bare-Metal Stent in Acute Myocardial Infarction Study) trials. JACC Cardiovasc Interv. 2011 Jan;4(1):66-75. doi: 10.1016/j.jcin.2010.09.017.

    PubMed 21251631

  • 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. doi: 10.1001/jama.299.15.joc80026. Epub 2008 Mar 30.

    PubMed 18375998

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing abciximab followed by implantation of bare metal stent, abciximab and Sirolimus eluting stent and tirofiban and bare metal stent in people with Myocardial Infarction, run by Marco Valgimigli at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The evaluation of the degree of ST-segment resolution after the mechanical intervention. (time frame: 90 minutes after last balloon inflation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00229515, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2011; AzTrials last refreshed its copy on 30 Oct 2026.

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