AzTrials
AzTrials

Acute Coronary SyndromesPhase 3MATRIXNCT01433627

Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX

A Phase 3 study testing trans-radial and short-term bivalirudin, trans-radial and long-term bivalirudin infusion and Trans-femoral and Short-term bivalirudin in people with Acute Coronary Syndromes and STEMI, run by Italian Society of Invasive Cardiology at 62 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This protocol describes a study to compare intended trans-radial versus trans-femoral intervention and bivalirudin monotherapy versus current European standard of care consisting of unfractionated heparin (UFH) plus provisional use of glycoprotein IIb/IIIa inhibition via the use of one of the three available agents on… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Coronary Syndromes, STEMI, NSTEMI
What is being tested?
trans-radial and short-term bivalirudin, trans-radial and long-term bivalirudin infusion and Trans-femoral and Short-term bivalirudin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7,200 participants
Where
62 sitesItaly
Study dates
Oct 2011to Dec 2015
Phase
Phase 3
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

  • NSTEACS definition: Patients with all of the following criteria will be eligible:
  • history consistent with new, or worsening ischemia, occurring at rest or with minimal activity;
  • enrollment within 7 days of the most recent symptoms;
  • planned coronary angiography with possible indication to PCI;
  • at least 2 of the following criteria: 1. Aged 60 years or older, 2. Troponin T or I or creatine kinase MB above the upper limit of normal; 3. Electrocardiograph changes compatible with ischemia, ie, ST depression of 1 mm or greater in 2 contiguous leads, T-wave inversion more than 3 mm, or any dynamic ST shifts;
  • STEMI definition: i) chest pain for >20 min with an electrocardiographic ST-segment elevation ≥1 mm in two or more contiguous electrocardiogram (ECG) leads, or with a new left bundle-branch block, or an infero-lateral myocardial infarction (MI) with ST segment depression of ≥1 mm in ≥2 of leads V1-3 with a positive terminal T wave and ii) admission either within 12 h of symptom onset or between 12 and 24 h after onset with evidence of continuing ischemia or previous lytic treatment.

Who cannot join

  • Patients who can not give informed consent or have a life expectancy of <30 days
  • Allergy/intolerance to Bivalirudin or unfractionated heparin.
  • Stable or silent CAD as indication to coronary angiography
  • Treatment with LWMH within the past 6 hours
  • Treatment with any GPI in the previous 3 days
  • Absolute contraindications or allergy that cannot be pre-medicated to iodinated contrast or to any of the study medications including aspirin or clopidogrel.
Show all 15Show fewer
  • Contraindications to angiography, including but not limited to severe peripheral vascular disease.
  • If it is known pregnant or nursing mothers. Women of child-bearing age will be asked if they are pregnant or think that they may be pregnant.
  • If it is known a creatinine clearance <30 mL/min or dialysis dependent.
  • Previous enrollment in this study.
  • Treatment with other investigational drugs or devices within the 30 days preceding
  • Randomisation or planned use of other investigational drugs or devices in this trial.
  • Severe uncontrolled hypertension (defined as persistent systolic blood pressure higher than 220 mmHg despite medical treatment).
  • Subacute bacterial endocarditis
  • PCI in the previous 30 days

Trial locations and contacts

62 sites in 1 country.

62 sites in 1 country

Italy62 sites

  • P.O. Zona Aretina-Ospedale San Donato

    Arezzo, Tuscany

  • A.O. G. Mazzoni

    Ascoli Piceno, The Marches

  • Ospedale Di Venere - ASL Bari

    Bari, Apulia

  • Policlinico Sant'Orsola Malpighi

    Bologna, Emilia-Romagna

  • Spedali Civili di Brescia

    Brescia, Lombardy

  • Azienda USL Sirai

    Carbonia, Sardinia

  • A. O. Universitaria Policlinico V. Emanuele Ferrarotto

    Catania, Sicily

  • Azienda Ospedaliera Pugliese Ciaccio - Catanzaro

    Catanzaro, Calabria

  • Ospedale Clinicizzato SS Annunziata di Chieti

    Chieti, Abruzzo

  • Azienda Ospedaliera Sant'Anna di Como

    Como, Lombardy

  • Maria Cecilia Hospital

    Cotignola, RA

  • Ospedale S. Croce e Carlo

    Cuneo, Piedmont

  • Azienda Ospedaliera di Desio e Vimercate - P.O. di Desio

    Desio, Lombardy

  • Ospedale Sacra Famiglia

    Erba, Lombardy

  • Presidio Ospedaliero di Este

    Este, Veneto

  • University Hospital of Ferrara

    Ferrara, Emilia-Romagna, 44100

  • Ospedale G. B. Morgagni

    Forlì, Emilia-Romagna

  • Azienda Ospedaliera Universitaria "San Martino"

    Genoa, Liguria

  • Ospedale Villa Scassi

    Genoa, Liguria

  • Azienda USL - Grosseto

    Grosseto, Tuscany

  • Ospedale Santa Maria Goretti

    Latina, Lazio

  • Città di Lecce Ospedale (GVM)

    Lecce, Apulia

  • Ospedale Vito Fazzi

    Lecce, Apulia

  • Ospedale Mater Salutis di Legnago

    Legnago, Veneto

  • Ospedale di Lodi

    Lodi, Lombardy

  • Ospedale del Cuore "G. Pasquinucci" Massa

    Massa Carrara, Tuscany

  • A.O: Fatebenefratelli e oftalmico

    Milan, Lombardy

  • Ospedale Civile di Mirano

    Mirano, Veneto

  • A.O. AORN Cardarelli

    Naples, Campania

  • Azienda Ospedaliera Monaldi

    Naples, Campania

  • Policlinico Federico II

    Naples, Campania

  • Azienda Ospedaliero-Universitaria "Maggiore della Carità"

    Novara, Piedmont

  • Ospedale San Francesco

    Nuoro, Sardinia

  • A. O. Universitaria San Luigi Gonzaga di Orbassano

    Orbassano, Piedmont

  • Villa Maria Eleonora Hospital

    Palermo, Sicily

  • Azienda Ospedaliera San Salvatore

    Pesaro, The Marches

  • Ospedale Civile Santo Spirito

    Pescara, Abruzzo

  • Azienda Ospedaliera Universitaria Pisana

    Pisa, Tuscany

  • Azienda S. Maria Nuova di Reggio Emilia

    Reggio Emilia, Emilia-Romagna

  • Ospedale degli Infermi

    Rimini, Emilia-Romagna

  • Ospedale degli Infermi

    Rivoli, TO

  • A.O. Sandro Pertini

    Rome, Lazio

  • Ospedale del Santo Spirito in Sassia

    Rome, Lazio

  • Ospedale San Camillo di Roma

    Rome, Lazio

  • Policlinico Casilino

    Rome, Lazio

  • Università Campus Bio-Medico di Roma

    Rome

  • Istituto Clinico Humanitas IRCCS

    Rozzano, MI

  • IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, Apulia

  • Ospedali Riuniti ASL 17

    Savigliano, Piedmont

  • A.O. Civili Riuniti - Giovanni Paolo II

    Sciacca, Sicily

  • IRCCS Multimedica

    Sesto San Giovanni, Lombardy

  • Ospedale Umberto I di Siracusa

    Syracuse, Sicily

  • Ospedale S. Vincenzo

    Taormina, Sicily

  • Casa di Cura Villa Verde

    Taranto, Apulia

  • Presidio Ospedaliero Santa Chiara

    Trento, Trentino-Alto Adige

  • A.O. Treviglio

    Treviglio, Lombardy

  • Azienda Ospedaliera Universitaria Ospedali Riuniti

    Trieste, Friuli Venezia Giulia

  • A.O. Universitaria Molinette San Giovanni Battista

    Turin, Piedmont

  • Ospedale San Giovanni Bosco

    Turin, Piedmont

  • Azienda Ospedaliera S. Maria della Misericordia di Udine

    Udine, Friuli Venezia Giulia

  • A. O. Ospedale Civile di Vimercate

    Vimercate, Lombardy

  • Policlinico San Marco

    Zingonia, Lombardy

Other trials in Italy

About this study

Official title: Phase IIIb Study Minimizing Adverse Haemmhorragic Events by TRansradial Access Site and Systemic Implementation of angioX (MATRIX)

This protocol describes a study to compare intended trans-radial versus trans-femoral intervention and bivalirudin monotherapy versus current European standard of care consisting of unfractionated heparin (UFH) plus provisional use of glycoprotein IIb/IIIa inhibition via the use of one of the three available agents on the market (e.g. abciximab, tirofiban or eptifibatide) in patients (≥18 years) with ACS, that are intended for an invasive management strategy. This study will be conducted in compliance with Good Clinical Practices (GCP) including the Declaration of Helsinki and all applicable regulatory requirements.

Read the detailed description

The use of combined antithrombotic therapies over the last two decades has decreased the risk of a heart attack after percutaneous coronary intervention substantially but has also been associated with a significant increase in bleeding risk. Therapies or strategies that maintain the benefits seen with currently available antithrombotic therapies but which have lower bleeding risk are therefore of great clinical importance. Indeed, major bleeding is currently the most common non-cardiac complication of therapy for patients with coronary artery disease who have undergone percutaneous coronary intervention (PCI).

Bleeding in patients with acute coronary syndrome (ACS) is associated with an increased risk of long term mortality and morbidity, and this relationship is currently thought to be causal. Therefore' reducing the frequency of bleeding events while maintaining efficacy is an important goal in the management of patients with ACS. The most common site of bleeding in invasively managed patients with ACS is at the femoral artery puncture site used for heart catheterization

The MATRIX study is a multi-centre, prospective, randomised, open-label, 2 by 2 factorial comparison of trans-radial vs. trans-femoral intervention and bivalirudin vs. unfractionated heparin and provisional use of glycoprotein IIb/IIIa inhibitor.

Objectives:

  1. To demonstrate that trans-radial intervention as compared to femoral access site is associated to lower rate of the composite endpoint of death, MI or stroke within the first 30 days after randomization in acute coronary syndrome patients undergoing early invasive management.
  2. To demonstrate that bivalirudin infusion as compared to standard of care therapy consisting of unfractionated heparin and provisional use of glycoprotein IIb/IIIa inhibitors are associated to lower rate of the composite endpoint of death, MI or stroke within the first 30 days after randomization in acute coronary syndrome patients undergoing early invasive management.

Patients randomly assigned to receive bivalirudin will be randomized to stop bivalirudin infusion at the end of PCI or to prolong bivalirudin at an infusion rate of 0.25 mg/kg/hour for at least 6 hours after completion of PCI. The primary hypothesis in this sub-randomization is that prolonged post-intervention bivalirudin infusion will be superior to no bivalirudin post-PCI infusion with respect to the net composite outcome consisting of any death, MI, stroke, urgent TVR, stent thrombosis and BARC-defined type 3 and 5 bleeding events within 30 days. Secondary objectives for the sub-randomization of prolonged bivalirudin versus no post-PCI infusion in the bivalirudin group will consist of each component of the primary composite endpoint through the entire follow-up duration

Being tested
trans-radial and short-term bivalirudin, trans-radial and long-term bivalirudin infusion, trans-radial and standard of care pharmacology, Trans-femoral and Short-term bivalirudin, trans-femoral and long-term bivalirudin infusion
Keywords
acute coronary syndromes, myocardial infarction, access site, bivalirudin, bleedings
Medical subject headings
Acute Coronary Syndrome, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction, Myocardial Infarction

What participants receive

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

  • trans-radial and short-term bivalirudinOther

    Also called Access site selection and drug administration

    trans-radial intervention followed by Bivalirudin given immediately upon enrolment as bolus of 0.75 mg/kg followed immediately by an infusion of 1.75 mg/kg/h. This infusion should be run continuously until completion of PCI at which time the infusion should be stopped.

  • trans-radial and long-term bivalirudin infusionOther

    Also called access site selection and drug administration

    Trans-radial intervention: will be performed according to institutional guidelines and established local practice.

    Bivalirudin: given immediately upon enrolment as bolus of 0.75 mg/kg followed immediately by an infusion of 1.75 mg/kg/h. This infusion should be run continuously until completion of PCI at which time the infusion should be reduced to a dose of 0.25 mg/kg/h for at least 6 hours. An optional higher-dose infusion of 1.75 mg/kg/h is also permitted for up to 4 hours in the prolonged infusion arm but prohibited in the short bivalirudin group.

  • trans-radial and standard of care pharmacologyOther

    Also called access site and drug administration

    Unfractionated heparin (UFH) (100 IU/kg with no glycoprotein IIb/IIIa inhibitor (GPI) and 60 IU/kg with a GPI); +/- routine or bail out eptifibatide (two 180 μg /kg boluses with a 10 minute interval followed by an infusion of 2.0 μg /kg/min for 72-96 hours) or tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18 to 24 hours) or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours (maximum dose, 10 μg/min).

  • Trans-femoral and Short-term bivalirudinOther

    Also called access site selection and drug administration

    Trans-femoral intervention: will be performed according to institutional guidelines and established local practice. Access closure devices are allowed as per local practice.

    Bivalirudin will be given immediately upon enrolment as bolus of 0.75 mg/kg followed immediately by an infusion of 1.75 mg/kg/h. This infusion should be run continuously until completion of PCI.

  • trans-femoral and long-term bivalirudin infusionOther

    Also called access site selection and drug administration

    Trans-femoral intervention: will be performed according to institutional guidelines and established local practice. Access closure devices are allowed as per local practice.

    Bivalirudin will be given immediately upon enrolment as bolus of 0.75 mg/kg followed immediately by an infusion of 1.75 mg/kg/h. This infusion should be run continuously until completion of PCI at which time the infusion should be reduced to a dose of 0.25 mg/kg/h for at least 6 hours. An optional higher-dose infusion of 1.75 mg/kg/h is also permitted for up to 4 hours in the prolonged infusion arm but prohibited in the short bivalirudin group.

  • trans-femoral and standard of care pharmacologyOther

    Also called access site selection and drug administration

    Trans-femoral intervention: will be performed according to institutional guidelines and established local practice. Access closure devices are allowed as per local practice. Unfractionated heparin (UFH) (100 IU/kg with no glycoprotein IIb/IIIa inhibitor (GPI) and 60 IU/kg with a GPI); +/- routine or bail out eptifibatide (two 180 μg /kg boluses with a 10 minute interval followed by an infusion of 2.0 μg /kg/min for 72-96 hours) or tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18 to 24 hours) or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours (maximum dose, 10 μg/min).

Study groups in NCT01433627
Study groupRoleWhat they receive
trans-radial and short-term BivalirudinExperimentalPatients will be randomized to receive a trans-radial intervention and concomitant bivalirudin infusion. bivalirudin will be stopped at the end of PCI.
Receives: Other: trans-radial and short-term bivalirudin
trans-radial and long-term bivalirudinExperimentalTrans-radial intervention: will be performed according to institutional guidelines and established local practice. Bivalirudin: given immediately upon enrolment as bolus of 0.75 mg/kg followed immediately by an infusion of 1.75 mg/kg/h. This infusion should be run continuously until completion of PCI at which time the infusion should be reduced to a dose of 0.25 mg/kg/h for at least 6 hours. An optional higher-dose infusion of 1.75 mg/kg/h is also permitted for up to 4 hours in the prolonged infusion arm but prohibited in the short bivalirudin group.
Receives: Other: trans-radial and long-term bivalirudin infusion
trans-radial and standard of care pharmacologyExperimentalTrans-radial intervention: will be performed according to institutional guidelines and established local practice. unfractionated heparin (UFH) which may be followed by the addition of a glycoprotein IIb/IIIa inhibitor
Receives: Other: trans-radial and standard of care pharmacology
trans-femoral and short-term bivalirudinExperimentalTrans-femoral intervention: will be performed according to institutional guidelines and established local practice. Access closure devices are allowed as per local practice. Bivalirudin will be given immediately upon enrolment as bolus of 0.75 mg/kg followed immediately by an infusion of 1.75 mg/kg/h. This infusion should be run continuously until completion of PCI.
Receives: Other: Trans-femoral and Short-term bivalirudin
Trans-femoral and long-term bivalirudinExperimentalTrans-femoral intervention: will be performed according to institutional guidelines and established local practice. Access closure devices are allowed as per local practice. Bivalirudin will be given immediately upon enrolment as bolus of 0.75 mg/kg followed immediately by an infusion of 1.75 mg/kg/h. This infusion should be run continuously until completion of PCI at which time the infusion should be reduced to a dose of 0.25 mg/kg/h for at least 6 hours. An optional higher-dose infusion of 1.75 mg/kg/h is also permitted for up to 4 hours in the prolonged infusion arm but prohibited in the short bivalirudin group.
Receives: Other: trans-femoral and long-term bivalirudin infusion
trans-femoral and standard of care pharmacologyActive comparatorTrans-femoral intervention: will be performed according to institutional guidelines and established local practice. Access closure devices are allowed as per local practice. Unfractionated heparin (UFH) (100 IU/kg with no glycoprotein IIb/IIIa inhibitor (GPI) and 60 IU/kg with a GPI); +/- routine or bail out eptifibatide (two 180 μg /kg boluses with a 10 minute interval followed by an infusion of 2.0 μg /kg/min for 72-96 hours) or tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18 to 24 hours) or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours (maximum dose, 10 μg/min).
Receives: Other: trans-femoral and standard of care pharmacology

What is being measured

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

  1. the composite of Death, non-fatal myocardial infarction or stroke

    To demonstrate in ACS patients undergoing an early invasive management, i.e. diagnostic coronary angiogram+PCI or ad hoc planned PCI that trans-radial intervention as compared to femoral access site is associated to lower rate of the composite endpoint of death, MI or stroke within the first 30 days after randomization.

    Measured: 30 days

  2. The composite of death, non-fatal myocardial infarction or stroke

    To demonstrate that in an ACS patients with an intended PCI treatment strategy or in whom upstream treatment was felt necessary by local investigators the use of bivalirudin as compared to unfractionated heparin (UFH) plus or minus Glycoprotein IIb/IIIa inhibitor (GPI) is associated to lower rate of the composite endpoint of death, MI or stroke within the first 30 days after randomization.

    Measured: 30 days

  3. Death, non-fatal myocardial infarction, stroke, stent thrombosis or BARC-defined type 3 or 5 bleedings

    The primary hypothesis of this sub-randomization is that prolonged post-intervention bivalirudin infusion (long bivalirudin arm) will be superior to peri-PCI bivalirudin infusion only (short bivalirudin arm) with respect to the net composite outcomes consisting of any death, MI, stroke, stent thrombosis or BARC-defined type 3 and 5 bleeding events within 30 days.

    Measured: 30 days

Secondary outcomes (2)

  1. the composite endpoint of death, MI, stroke or BARC-defined type 3 and 5 major bleeding complications

    Key secondary objective: To demonstrate that trans-radial intervention as compared to femoral access site is associated to lower rate of the composite endpoint of death, MI, stroke or BARC-defined type 3 and 5 major bleeding complications within the first 30 days after randomization.

    Measured: 30 days

  2. Death, non-fatal MI, stroke or BARC-defined type 3 and 5 major bleeding

    To demonstrate that use of bivalirudin as compared to unfractionated heparin (UFH) plus or minus Glycoprotein IIb/IIIa inhibitor (GPI) is associated to lower rate of the composite endpoint of death, MI, stroke or BARC-defined type 3 and 5 major bleeding complications within the first 30 days after randomization.

    Measured: 30 days

Timeline

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

  1. First posted14 Sep 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionNov 2014
  4. Study completionDec 2015 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
7,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01433627
Sponsor's protocol ID
RFBU 11-I
Other IDs
2011-000430-11
Acronym
MATRIX
Status last verified
Jan 2015
First submitted
12 Sep 2011
Last updated
29 Jan 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Leonardi S, Landi A, Zito A, Branca M, Frigoli E, Ando' G, Briguori C, Calabro P, Gagnor A, Garbo R, Heg D, Limbruno U, Milzi A, Omerovic E, Russo F, Sabate M, Santarelli A, Sardella G, Tosi P, Van't Hof AWJ, Vranckx P, Valgimigli M. Prognostic Implications of Evolving Universal Definitions of Periprocedural Myocardial Infarction in Patients With Acute Coronary Syndrome. Circulation. 2026 Jan 27;153(4):230-242. doi: 10.1161/CIRCULATIONAHA.125.077174. Epub 2026 Jan 6.

    PubMed 41493005

  • Landi A, Zito A, Singh M, Angiolillo DJ, Capodanno D, Frigoli E, Milzi A, Rao SV, Urban P, Valgimigli M. Validation of the Mayo Clinic Percutaneous Coronary Intervention Risk Prediction Score in Patients With Acute Coronary Syndrome. J Am Heart Assoc. 2025 Oct 21;14(20):e043012. doi: 10.1161/JAHA.125.043012. Epub 2025 Oct 9.

    PubMed 41065238

  • Landi A, Chiarito M, Branca M, Frigoli E, Gagnor A, Calabro P, Briguori C, Ando G, Repetto A, Limbruno U, Sganzerla P, Lupi A, Cortese B, Ausiello A, Ierna S, Esposito G, Ferrante G, Santarelli A, Sardella G, Varbella F, Heg D, Mehran R, Valgimigli M. Validation of a Contemporary Acute Kidney Injury Risk Score in Patients With Acute Coronary Syndrome. JACC Cardiovasc Interv. 2023 Aug 14;16(15):1873-1886. doi: 10.1016/j.jcin.2023.06.015.

    PubMed 37587595

  • Garg M, Garcia-Garcia HM, Calderon AT, Gupta J, Sortur S, Levine MB, Singla P, Picchi A, Sardella G, Adamo M, Frigoli E, Limbruno U, Rigattieri S, Diletti R, Boccuzzi G, Zimarino M, Contarini M, Russo F, Calabro P, Ando G, Varbella F, Garducci S, Palmieri C, Briguori C, Sanchez JS, Valgimigli M. Reproducibility of an artificial intelligence optical coherence tomography software for tissue characterization: Implications for the design of longitudinal studies. Cardiovasc Revasc Med. 2024 Jan;58:79-87. doi: 10.1016/j.carrev.2023.07.003. Epub 2023 Jul 16.

    PubMed 37474355

  • Landi A, Branca M, Leonardi S, Frigoli E, Vranckx P, Tebaldi M, Varbella F, Calabro P, Esposito G, Sardella G, Garducci S, Ando G, Limbruno U, Sganzerla P, Santarelli A, Briguori C, Colangelo S, Brugaletta S, Adamo M, Omerovic E, Heg D, Windecker S, Valgimigli M; MATRIX Investigators. Transient vs In-Hospital Persistent Acute Kidney Injury in Patients With Acute Coronary Syndrome. JACC Cardiovasc Interv. 2023 Jan 23;16(2):193-205. doi: 10.1016/j.jcin.2022.10.009. Epub 2022 Dec 28.

    PubMed 36697156

  • Dan K, Garcia-Garcia HM, Yacob O, Kuku KO, Diaz-Torres MA, Picchi A, Sardella G, Adamo M, Frigoli E, Limbruno U, Rigattieri S, Diletti R, Boccuzzi G, Zimarino M, Contarini M, Russo F, Calabro P, Ando G, Varbella F, Garducci S, Palmieri C, Briguori C, Karagiannis A, Dijkstra J, Valgimigli M. Ultra-Short Term Evaluation of Coronary Vessel Wall Changes in Reference Segments Adjacent to Culprit Lesions in ST-Segment Elevation Myocardial Infarction. J Invasive Cardiol. 2021 Dec;33(12):E923-E930. doi: 10.25270/jic/21.00035. Epub 2021 Nov 18.

    PubMed 34792483

  • Landi A, Branca M, Ando G, Russo F, Frigoli E, Gargiulo G, Briguori C, Vranckx P, Leonardi S, Gragnano F, Calabro P, Campo G, Ambrosio G, Santucci A, Varbella F, Zaro T, Heg D, Windecker S, Juni P, Pedrazzini G, Valgimigli M; MATRIX Investigators. Acute kidney injury in patients with acute coronary syndrome undergoing invasive management treated with bivalirudin vs. unfractionated heparin: insights from the MATRIX trial. Eur Heart J Acute Cardiovasc Care. 2021 Dec 18;10(10):1170-1179. doi: 10.1093/ehjacc/zuab080.

    PubMed 34491323

  • Gragnano F, Branca M, Frigoli E, Leonardi S, Vranckx P, Di Maio D, Monda E, Fimiani L, Fioretti V, Chianese S, Esposito F, Franzese M, Scalise M, D'Angelo C, Scalise R, De Blasi G, Ando G, Esposito G, Calabro P, Windecker S, Pedrazzini G, Valgimigli M; MATRIX Trial Investigators. Access-Site Crossover in Patients With Acute Coronary Syndrome Undergoing Invasive Management. JACC Cardiovasc Interv. 2021 Feb 22;14(4):361-373. doi: 10.1016/j.jcin.2020.11.042.

    PubMed 33602431

  • Leonardi S, Gragnano F, Carrara G, Gargiulo G, Frigoli E, Vranckx P, Di Maio D, Spedicato V, Monda E, Fimiani L, Fioretti V, Esposito F, Avvedimento M, Magliulo F, Leone A, Chianese S, Franzese M, Scalise M, Schiavo A, Mazzone P, Esposito G, Ando G, Calabro P, Windecker S, Valgimigli M. Prognostic Implications of Declining Hemoglobin Content in Patients Hospitalized With Acute Coronary Syndromes. J Am Coll Cardiol. 2021 Feb 2;77(4):375-388. doi: 10.1016/j.jacc.2020.11.046.

    PubMed 33509394

  • Gargiulo G, Valgimigli M, Sunnaker M, Vranckx P, Frigoli E, Leonardi S, Spirito A, Gragnano F, Manavifar N, Galea R, De Caterina AR, Calabro P, Esposito G, Windecker S, Hunziker L. Choice of access site and type of anticoagulant in acute coronary syndromes with advanced Killip class or out-of-hospital cardiac arrest. Rev Esp Cardiol (Engl Ed). 2020 Nov;73(11):893-901. doi: 10.1016/j.rec.2020.01.005. Epub 2020 Mar 6. English, Spanish.

    PubMed 32151464

  • Garcia-Garcia HM, Picchi A, Sardella G, Adamo M, Frigoli E, Limbruno U, Rigattieri S, Diletti R, Boccuzzi G, Zimarino M, Contarini M, Russo F, Calabro' P, Ando G, Varbella F, Garducci S, Palmieri C, Briguori C, Kuku KO, Rothenbuhler M, Karagiannis A, Valgimigli M. Comparison of intra-procedural vs. post-stenting prolonged bivalirudin infusion for residual thrombus burden in patients with ST-segment elevation myocardial infarction undergoing: the MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and angioX) OCT study. Eur Heart J Cardiovasc Imaging. 2019 Dec 1;20(12):1418-1428. doi: 10.1093/ehjci/jez040.

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing trans-radial and short-term bivalirudin, trans-radial and long-term bivalirudin infusion and Trans-femoral and Short-term bivalirudin in people with Acute Coronary Syndromes and STEMI, run by Italian Society of Invasive Cardiology at 62 sites 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 6 inclusion and 15 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 29 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 composite of Death, non-fatal myocardial infarction or stroke (time frame: 30 days). The study lists 3 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 NCT01433627, which also lists 23 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 29 Jan 2015.

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