Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX
MATRIX
Phase IIIb Study Minimizing Adverse Haemmhorragic Events by TRansradial Access Site and Systemic Implementation of angioX (MATRIX)
2 other identifiers
interventional
7,200
1 country
62
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2011
Typical duration for phase_3
62 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2011
CompletedFirst Posted
Study publicly available on registry
September 14, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJanuary 29, 2015
January 1, 2015
3.1 years
September 12, 2011
January 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
30 days
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.
30 days
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.
30 days
Secondary Outcomes (2)
the composite endpoint of death, MI, stroke or BARC-defined type 3 and 5 major bleeding complications
30 days
Death, non-fatal MI, stroke or BARC-defined type 3 and 5 major bleeding
30 days
Study Arms (6)
trans-radial and short-term Bivalirudin
EXPERIMENTALPatients will be randomized to receive a trans-radial intervention and concomitant bivalirudin infusion. bivalirudin will be stopped at the end of PCI.
trans-radial and long-term bivalirudin
EXPERIMENTALTrans-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 pharmacology
EXPERIMENTALTrans-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
trans-femoral and short-term bivalirudin
EXPERIMENTALTrans-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
EXPERIMENTALTrans-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 pharmacology
ACTIVE 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).
Interventions
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 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.
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 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 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 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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Italian Society of Invasive Cardiologylead
- Eustrategycollaborator
Study Sites (62)
Ospedale Clinicizzato SS Annunziata di Chieti
Chieti, Abruzzo, Italy
Ospedale Civile Santo Spirito
Pescara, Abruzzo, Italy
Ospedale Di Venere - ASL Bari
Bari, Apulia, Italy
Città di Lecce Ospedale (GVM)
Lecce, Apulia, Italy
Ospedale Vito Fazzi
Lecce, Apulia, Italy
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Apulia, Italy
Casa di Cura Villa Verde
Taranto, Apulia, Italy
Azienda Ospedaliera Pugliese Ciaccio - Catanzaro
Catanzaro, Calabria, Italy
A.O. AORN Cardarelli
Napoli, Campania, Italy
Azienda Ospedaliera Monaldi
Napoli, Campania, Italy
Policlinico Federico II
Napoli, Campania, Italy
Policlinico Sant'Orsola Malpighi
Bologna, Emilia-Romagna, Italy
University Hospital of Ferrara
Ferrara, Emilia-Romagna, 44100, Italy
Ospedale G. B. Morgagni
Forlì, Emilia-Romagna, Italy
Azienda S. Maria Nuova di Reggio Emilia
Reggio Emilia, Emilia-Romagna, Italy
Ospedale degli Infermi
Rimini, Emilia-Romagna, Italy
Azienda Ospedaliera Universitaria Ospedali Riuniti
Trieste, Friuli Venezia Giulia, Italy
Azienda Ospedaliera S. Maria della Misericordia di Udine
Udine, Friuli Venezia Giulia, Italy
Ospedale Santa Maria Goretti
Latina, Lazio, Italy
A.O. Sandro Pertini
Rome, Lazio, Italy
Ospedale del Santo Spirito in Sassia
Rome, Lazio, Italy
Ospedale San Camillo di Roma
Rome, Lazio, Italy
Policlinico Casilino
Rome, Lazio, Italy
Azienda Ospedaliera Universitaria "San Martino"
Genoa, Liguria, Italy
Ospedale Villa Scassi
Genoa, Liguria, Italy
Spedali Civili di Brescia
Brescia, Lombardy, Italy
Azienda Ospedaliera Sant'Anna di Como
Como, Lombardy, Italy
Azienda Ospedaliera di Desio e Vimercate - P.O. di Desio
Desio, Lombardy, Italy
Ospedale Sacra Famiglia
Erba, Lombardy, Italy
Ospedale di Lodi
Lodi, Lombardy, Italy
A.O: Fatebenefratelli e oftalmico
Milan, Lombardy, Italy
IRCCS Multimedica
Sesto San Giovanni, Lombardy, Italy
A.O. Treviglio
Treviglio, Lombardy, Italy
A. O. Ospedale Civile di Vimercate
Vimercate, Lombardy, Italy
Policlinico San Marco
Zingonia, Lombardy, Italy
Istituto Clinico Humanitas IRCCS
Rozzano, MI, Italy
Ospedale S. Croce e Carlo
Cuneo, Piedmont, Italy
Azienda Ospedaliero-Universitaria "Maggiore della Carità"
Novara, Piedmont, Italy
A. O. Universitaria San Luigi Gonzaga di Orbassano
Orbassano, Piedmont, Italy
Ospedali Riuniti ASL 17
Savigliano, Piedmont, Italy
A.O. Universitaria Molinette San Giovanni Battista
Turin, Piedmont, Italy
Ospedale San Giovanni Bosco
Turin, Piedmont, Italy
Maria Cecilia Hospital
Cotignola, RA, Italy
Azienda USL Sirai
Carbonia, Sardinia, Italy
Ospedale San Francesco
Nuoro, Sardinia, Italy
A. O. Universitaria Policlinico V. Emanuele Ferrarotto
Catania, Sicily, Italy
Villa Maria Eleonora Hospital
Palermo, Sicily, Italy
A.O. Civili Riuniti - Giovanni Paolo II
Sciacca, Sicily, Italy
Ospedale Umberto I di Siracusa
Syracuse, Sicily, Italy
Ospedale S. Vincenzo
Taormina, Sicily, Italy
A.O. G. Mazzoni
Ascoli Piceno, The Marches, Italy
Azienda Ospedaliera San Salvatore
Pesaro, The Marches, Italy
Ospedale degli Infermi
Rivoli, TO, Italy
Presidio Ospedaliero Santa Chiara
Trento, Trentino-Alto Adige, Italy
P.O. Zona Aretina-Ospedale San Donato
Arezzo, Tuscany, Italy
Azienda USL - Grosseto
Grosseto, Tuscany, Italy
Ospedale del Cuore "G. Pasquinucci" Massa
Massa Carrara, Tuscany, Italy
Azienda Ospedaliera Universitaria Pisana
Pisa, Tuscany, Italy
Presidio Ospedaliero di Este
Este, Veneto, Italy
Ospedale Mater Salutis di Legnago
Legnago, Veneto, Italy
Ospedale Civile di Mirano
Mirano, Veneto, Italy
Università Campus Bio-Medico di Roma
Rome, Italy
Related Publications (23)
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 6. doi: 10.1161/CIRCULATIONAHA.125.077174. Online ahead of print.
PMID: 41493005DERIVEDLandi 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.
PMID: 41065238DERIVEDLandi 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.
PMID: 37587595DERIVEDGarg 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.
PMID: 37474355DERIVEDLandi 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.
PMID: 36697156DERIVEDDan 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.
PMID: 34792483DERIVEDLandi 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.
PMID: 34491323DERIVEDGragnano 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.
PMID: 33602431DERIVEDLeonardi 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.
PMID: 33509394DERIVEDGargiulo 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.
PMID: 32151464DERIVEDGarcia-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.
PMID: 30920584DERIVEDGargiulo G, Carrara G, Frigoli E, Leonardi S, Vranckx P, Campo G, Varbella F, Calabro P, Zaro T, Bartolini D, Briguori C, Ando G, Ferrario M, Limbruno U, Colangelo S, Sganzerla P, Russo F, Nazzaro MS, Esposito G, Ferrante G, Santarelli A, Sardella G, Windecker S, Valgimigli M. Post-Procedural Bivalirudin Infusion at Full or Low Regimen in Patients With Acute Coronary Syndrome. J Am Coll Cardiol. 2019 Feb 26;73(7):758-774. doi: 10.1016/j.jacc.2018.12.023.
PMID: 30784669DERIVEDValgimigli M, Frigoli E, Leonardi S, Vranckx P, Rothenbuhler M, Tebaldi M, Varbella F, Calabro P, Garducci S, Rubartelli P, Briguori C, Ando G, Ferrario M, Limbruno U, Garbo R, Sganzerla P, Russo F, Nazzaro M, Lupi A, Cortese B, Ausiello A, Ierna S, Esposito G, Ferrante G, Santarelli A, Sardella G, de Cesare N, Tosi P, van 't Hof A, Omerovic E, Brugaletta S, Windecker S, Heg D, Juni P; MATRIX Investigators. Radial versus femoral access and bivalirudin versus unfractionated heparin in invasively managed patients with acute coronary syndrome (MATRIX): final 1-year results of a multicentre, randomised controlled trial. Lancet. 2018 Sep 8;392(10150):835-848. doi: 10.1016/S0140-6736(18)31714-8. Epub 2018 Aug 25.
PMID: 30153988DERIVEDGargiulo G, Carrara G, Frigoli E, Vranckx P, Leonardi S, Ciociano N, Campo G, Varbella F, Calabro P, Garducci S, Iannone A, Briguori C, Ando G, Crimi G, Limbruno U, Garbo R, Sganzerla P, Russo F, Lupi A, Cortese B, Ausiello A, Ierna S, Esposito G, Zavalloni D, Santarelli A, Sardella G, Tresoldi S, de Cesare N, Sciahbasi A, Zingarelli A, Tosi P, van 't Hof A, Omerovic E, Brugaletta S, Windecker S, Valgimigli M. Bivalirudin or Heparin in Patients Undergoing Invasive Management of Acute Coronary Syndromes. J Am Coll Cardiol. 2018 Mar 20;71(11):1231-1242. doi: 10.1016/j.jacc.2018.01.033.
PMID: 29544607DERIVEDGargiulo G, Ariotti S, Vranckx P, Leonardi S, Frigoli E, Ciociano N, Tumscitz C, Tomassini F, Calabro P, Garducci S, Crimi G, Ando G, Ferrario M, Limbruno U, Cortese B, Sganzerla P, Lupi A, Russo F, Garbo R, Ausiello A, Zavalloni D, Sardella G, Esposito G, Santarelli A, Tresoldi S, Nazzaro MS, Zingarelli A, Petronio AS, Windecker S, da Costa BR, Valgimigli M. Impact of Sex on Comparative Outcomes of Radial Versus Femoral Access in Patients With Acute Coronary Syndromes Undergoing Invasive Management: Data From the Randomized MATRIX-Access Trial. JACC Cardiovasc Interv. 2018 Jan 8;11(1):36-50. doi: 10.1016/j.jcin.2017.09.014.
PMID: 29301646DERIVEDAndo G, Cortese B, Russo F, Rothenbuhler M, Frigoli E, Gargiulo G, Briguori C, Vranckx P, Leonardi S, Guiducci V, Belloni F, Ferrari F, de la Torre Hernandez JM, Curello S, Liistro F, Perkan A, De Servi S, Casu G, Dellavalle A, Fischetti D, Micari A, Loi B, Mangiacapra F, Russo N, Tarantino F, Saia F, Heg D, Windecker S, Juni P, Valgimigli M; MATRIX Investigators. Acute Kidney Injury After Radial or Femoral Access for Invasive Acute Coronary Syndrome Management: AKI-MATRIX. J Am Coll Cardiol. 2017 May 11:S0735-1097(17)36897-3. doi: 10.1016/j.jacc.2017.02.070. Online ahead of print.
PMID: 28528767DERIVEDLeonardi S, Frigoli E, Rothenbuhler M, Navarese E, Calabro P, Bellotti P, Briguori C, Ferlini M, Cortese B, Lupi A, Lerna S, Zavallonito-Parenti D, Esposito G, Tresoldi S, Zingarelli A, Rigattieri S, Palmieri C, Liso A, Abate F, Zimarino M, Comeglio M, Gabrielli G, Chieffo A, Brugaletta S, Mauro C, Van Mieghem NM, Heg D, Juni P, Windecker S, Valgimigli M; MATRIX Investigators. Bivalirudin or unfractionated heparin in patients with acute coronary syndromes managed invasively with and without ST elevation (MATRIX): randomised controlled trial. BMJ. 2016 Sep 27;354:i4935. doi: 10.1136/bmj.i4935.
PMID: 27677503DERIVEDValgimigli M, Frigoli E, Leonardi S, Rothenbuhler M, Gagnor A, Calabro P, Garducci S, Rubartelli P, Briguori C, Ando G, Repetto A, Limbruno U, Garbo R, Sganzerla P, Russo F, Lupi A, Cortese B, Ausiello A, Ierna S, Esposito G, Presbitero P, Santarelli A, Sardella G, Varbella F, Tresoldi S, de Cesare N, Rigattieri S, Zingarelli A, Tosi P, van 't Hof A, Boccuzzi G, Omerovic E, Sabate M, Heg D, Juni P, Vranckx P; MATRIX Investigators. Bivalirudin or Unfractionated Heparin in Acute Coronary Syndromes. N Engl J Med. 2015 Sep 10;373(11):997-1009. doi: 10.1056/NEJMoa1507854. Epub 2015 Sep 1.
PMID: 26324049DERIVEDAndo G, Cortese B, Frigoli E, Gagnor A, Garducci S, Briguori C, Rubartelli P, Calabro P, Valgimigli M; MATRIX investigators. Acute kidney injury after percutaneous coronary intervention: Rationale of the AKI-MATRIX (acute kidney injury-minimizing adverse hemorrhagic events by TRansradial access site and systemic implementation of angioX) sub-study. Catheter Cardiovasc Interv. 2015 Nov;86(5):950-7. doi: 10.1002/ccd.25932. Epub 2015 Apr 9.
PMID: 25854692DERIVEDValgimigli M, Gagnor A, Calabro P, Frigoli E, Leonardi S, Zaro T, Rubartelli P, Briguori C, Ando G, Repetto A, Limbruno U, Cortese B, Sganzerla P, Lupi A, Galli M, Colangelo S, Ierna S, Ausiello A, Presbitero P, Sardella G, Varbella F, Esposito G, Santarelli A, Tresoldi S, Nazzaro M, Zingarelli A, de Cesare N, Rigattieri S, Tosi P, Palmieri C, Brugaletta S, Rao SV, Heg D, Rothenbuhler M, Vranckx P, Juni P; MATRIX Investigators. Radial versus femoral access in patients with acute coronary syndromes undergoing invasive management: a randomised multicentre trial. Lancet. 2015 Jun 20;385(9986):2465-76. doi: 10.1016/S0140-6736(15)60292-6. Epub 2015 Mar 16.
PMID: 25791214DERIVEDValgimigli M; MATRIX investigators. Design and rationale for the Minimizing Adverse haemorrhagic events by TRansradial access site and systemic Implementation of angioX program. Am Heart J. 2014 Dec;168(6):838-45.e6. doi: 10.1016/j.ahj.2014.08.013. Epub 2014 Sep 16.
PMID: 25458646DERIVEDSciahbasi A, Calabro P, Sarandrea A, Rigattieri S, Tomassini F, Sardella G, Zavalloni D, Cortese B, Limbruno U, Tebaldi M, Gagnor A, Rubartelli P, Zingarelli A, Valgimigli M. Randomized comparison of operator radiation exposure comparing transradial and transfemoral approach for percutaneous coronary procedures: rationale and design of the minimizing adverse haemorrhagic events by TRansradial access site and systemic implementation of angioX - RAdiation Dose study (RAD-MATRIX). Cardiovasc Revasc Med. 2014 Jun;15(4):209-13. doi: 10.1016/j.carrev.2014.03.010. Epub 2014 Mar 26.
PMID: 24746599DERIVEDValgimigli M, Calabro P, Cortese B, Frigoli E, Garducci S, Rubartelli P, Ando G, Santarelli A, Galli M, Garbo R, Repetto A, Ierna S, Briguori C, Limbruno U, Violini R, Gagnor A; MATRIX investigators. Scientific foundation and possible implications for practice of the Minimizing Adverse Haemorrhagic Events by Transradial Access Site andSystemic Implementation of AngioX (MATRIX) trial. J Cardiovasc Transl Res. 2014 Feb;7(1):101-11. doi: 10.1007/s12265-013-9537-1. Epub 2014 Jan 7.
PMID: 24395497DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marco Valgimigli, MD PhD
Erasmus MC, Thoraxcenter, The Netherlands
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2011
First Posted
September 14, 2011
Study Start
October 1, 2011
Primary Completion
November 1, 2014
Study Completion
December 1, 2015
Last Updated
January 29, 2015
Record last verified: 2015-01