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

NCT ID: NCT01433627

Last Updated: 2015-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

7200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Acute Coronary Syndromes STEMI NSTEMI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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trans-radial and short-term Bivalirudin

Patients will be randomized to receive a trans-radial intervention and concomitant bivalirudin infusion. bivalirudin will be stopped at the end of PCI.

Group Type EXPERIMENTAL

trans-radial and short-term bivalirudin

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

trans-radial and long-term bivalirudin infusion

Intervention Type OTHER

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 pharmacology

Trans-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

Group Type EXPERIMENTAL

trans-radial and standard of care pharmacology

Intervention Type OTHER

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 bivalirudin

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.

Group Type EXPERIMENTAL

Trans-femoral and Short-term bivalirudin

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

trans-femoral and long-term bivalirudin infusion

Intervention Type OTHER

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 pharmacology

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).

Group Type ACTIVE_COMPARATOR

trans-femoral and standard of care pharmacology

Intervention Type OTHER

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).

Interventions

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trans-radial and short-term bivalirudin

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.

Intervention Type OTHER

trans-radial and long-term bivalirudin infusion

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.

Intervention Type OTHER

trans-radial and standard of care pharmacology

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).

Intervention Type OTHER

Trans-femoral and Short-term bivalirudin

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.

Intervention Type OTHER

trans-femoral and long-term bivalirudin infusion

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.

Intervention Type OTHER

trans-femoral and standard of care pharmacology

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).

Intervention Type OTHER

Other Intervention Names

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Access site selection and drug administration access site selection and drug administration access site and drug administration access site selection and drug administration access site selection and drug administration access site selection and drug administration

Eligibility Criteria

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Inclusion Criteria

NSTEACS definition: Patients with all of the following criteria will be eligible:

1. history consistent with new, or worsening ischemia, occurring at rest or with minimal activity;
2. enrollment within 7 days of the most recent symptoms;
3. planned coronary angiography with possible indication to PCI;
4. 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.

Exclusion Criteria

1. Patients who can not give informed consent or have a life expectancy of \<30 days
2. Allergy/intolerance to Bivalirudin or unfractionated heparin.
3. Stable or silent CAD as indication to coronary angiography
4. Treatment with LWMH within the past 6 hours
5. Treatment with any GPI in the previous 3 days
6. Absolute contraindications or allergy that cannot be pre-medicated to iodinated contrast or to any of the study medications including aspirin or clopidogrel.
7. Contraindications to angiography, including but not limited to severe peripheral vascular disease.
8. 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.
9. If it is known a creatinine clearance \<30 mL/min or dialysis dependent.
10. Previous enrollment in this study.
11. Treatment with other investigational drugs or devices within the 30 days preceding
12. Randomisation or planned use of other investigational drugs or devices in this trial.
13. Severe uncontrolled hypertension (defined as persistent systolic blood pressure higher than 220 mmHg despite medical treatment).
14. Subacute bacterial endocarditis
15. PCI in the previous 30 days
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eustrategy

OTHER

Sponsor Role collaborator

Italian Society of Invasive Cardiology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marco Valgimigli, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus MC, Thoraxcenter, The Netherlands

Locations

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Ospedale Clinicizzato SS Annunziata di Chieti

Chieti, Abruzzo, Italy

Site Status

Ospedale Civile Santo Spirito

Pescara, Abruzzo, Italy

Site Status

Ospedale Di Venere - ASL Bari

Bari, Apulia, Italy

Site Status

Città di Lecce Ospedale (GVM)

Lecce, Apulia, Italy

Site Status

Ospedale Vito Fazzi

Lecce, Apulia, Italy

Site Status

IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, Apulia, Italy

Site Status

Casa di Cura Villa Verde

Taranto, Apulia, Italy

Site Status

Azienda Ospedaliera Pugliese Ciaccio - Catanzaro

Catanzaro, Calabria, Italy

Site Status

A.O. AORN Cardarelli

Napoli, Campania, Italy

Site Status

Azienda Ospedaliera Monaldi

Napoli, Campania, Italy

Site Status

Policlinico Federico II

Napoli, Campania, Italy

Site Status

Policlinico Sant'Orsola Malpighi

Bologna, Emilia-Romagna, Italy

Site Status

University Hospital of Ferrara

Ferrara, Emilia-Romagna, Italy

Site Status

Ospedale G. B. Morgagni

Forlì, Emilia-Romagna, Italy

Site Status

Azienda S. Maria Nuova di Reggio Emilia

Reggio Emilia, Emilia-Romagna, Italy

Site Status

Ospedale degli Infermi

Rimini, Emilia-Romagna, Italy

Site Status

Azienda Ospedaliera Universitaria Ospedali Riuniti

Trieste, Friuli Venezia Giulia, Italy

Site Status

Azienda Ospedaliera S. Maria della Misericordia di Udine

Udine, Friuli Venezia Giulia, Italy

Site Status

Ospedale Santa Maria Goretti

Latina, Lazio, Italy

Site Status

A.O. Sandro Pertini

Rome, Lazio, Italy

Site Status

Ospedale del Santo Spirito in Sassia

Rome, Lazio, Italy

Site Status

Ospedale San Camillo di Roma

Rome, Lazio, Italy

Site Status

Policlinico Casilino

Rome, Lazio, Italy

Site Status

Azienda Ospedaliera Universitaria "San Martino"

Genoa, Liguria, Italy

Site Status

Ospedale Villa Scassi

Genoa, Liguria, Italy

Site Status

Spedali Civili di Brescia

Brescia, Lombardy, Italy

Site Status

Azienda Ospedaliera Sant'Anna di Como

Como, Lombardy, Italy

Site Status

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

Desio, Lombardy, Italy

Site Status

Ospedale Sacra Famiglia

Erba, Lombardy, Italy

Site Status

Ospedale di Lodi

Lodi, Lombardy, Italy

Site Status

A.O: Fatebenefratelli e oftalmico

Milan, Lombardy, Italy

Site Status

IRCCS Multimedica

Sesto San Giovanni, Lombardy, Italy

Site Status

A.O. Treviglio

Treviglio, Lombardy, Italy

Site Status

A. O. Ospedale Civile di Vimercate

Vimercate, Lombardy, Italy

Site Status

Policlinico San Marco

Zingonia, Lombardy, Italy

Site Status

Istituto Clinico Humanitas IRCCS

Rozzano, MI, Italy

Site Status

Ospedale S. Croce e Carlo

Cuneo, Piedmont, Italy

Site Status

Azienda Ospedaliero-Universitaria "Maggiore della Carità"

Novara, Piedmont, Italy

Site Status

A. O. Universitaria San Luigi Gonzaga di Orbassano

Orbassano, Piedmont, Italy

Site Status

Ospedali Riuniti ASL 17

Savigliano, Piedmont, Italy

Site Status

A.O. Universitaria Molinette San Giovanni Battista

Turin, Piedmont, Italy

Site Status

Ospedale San Giovanni Bosco

Turin, Piedmont, Italy

Site Status

Maria Cecilia Hospital

Cotignola, RA, Italy

Site Status

Azienda USL Sirai

Carbonia, Sardinia, Italy

Site Status

Ospedale San Francesco

Nuoro, Sardinia, Italy

Site Status

A. O. Universitaria Policlinico V. Emanuele Ferrarotto

Catania, Sicily, Italy

Site Status

Villa Maria Eleonora Hospital

Palermo, Sicily, Italy

Site Status

A.O. Civili Riuniti - Giovanni Paolo II

Sciacca, Sicily, Italy

Site Status

Ospedale Umberto I di Siracusa

Syracuse, Sicily, Italy

Site Status

Ospedale S. Vincenzo

Taormina, Sicily, Italy

Site Status

A.O. G. Mazzoni

Ascoli Piceno, The Marches, Italy

Site Status

Azienda Ospedaliera San Salvatore

Pesaro, The Marches, Italy

Site Status

Ospedale degli Infermi

Rivoli, TO, Italy

Site Status

Presidio Ospedaliero Santa Chiara

Trento, Trentino-Alto Adige, Italy

Site Status

P.O. Zona Aretina-Ospedale San Donato

Arezzo, Tuscany, Italy

Site Status

Azienda USL - Grosseto

Grosseto, Tuscany, Italy

Site Status

Ospedale del Cuore "G. Pasquinucci" Massa

Massa Carrara, Tuscany, Italy

Site Status

Azienda Ospedaliera Universitaria Pisana

Pisa, Tuscany, Italy

Site Status

Presidio Ospedaliero di Este

Este, Veneto, Italy

Site Status

Ospedale Mater Salutis di Legnago

Legnago, Veneto, Italy

Site Status

Ospedale Civile di Mirano

Mirano, Veneto, Italy

Site Status

Università Campus Bio-Medico di Roma

Rome, , Italy

Site Status

Countries

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Italy

References

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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.

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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.

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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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Gargiulo 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.

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Valgimigli 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.

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Gargiulo 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.

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Gargiulo 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.

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Ando 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.

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Leonardi 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.

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Valgimigli 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.

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Ando 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.

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Valgimigli 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.

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Valgimigli 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.

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Sciahbasi 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.

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Valgimigli 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.

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PMID: 24395497 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2011-000430-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

RFBU 11-I

Identifier Type: -

Identifier Source: org_study_id

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