GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by ECRI bv
Sponsor:
Collaborators:
Biosensors International
AstraZeneca
The Medicines Company
Information provided by (Responsible Party):
ECRI bv
ClinicalTrials.gov Identifier:
NCT01813435
First received: February 12, 2013
Last updated: September 14, 2014
Last verified: September 2014
  Purpose

After a stent procedure, it is common practice to prescribe anti-platelet medication to prevent the blood from clotting. The main objective of this study is to determine if there is a better medication strategy to prevent blood from clotting and at the same time minimising the number of complications.

There are two medication strategies:

  • Study group: Dual anti-platelet therapy (ticagrelor combined with aspirin) for 1 month, and then ticagrelor alone for another 23 months OR
  • Control group: Standard treatment, being dual anti-platelet therapy (ticagrelor or clopidogrel combined with aspirin) for 12 months, and then aspirin alone indefinitely

Condition Intervention Phase
Coronary Artery Disease (CAD)
Drug: Ticagrelor
Drug: Acetylsalicylic Acid
Drug: Clopidogrel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparative Effectiveness of 1 Month of Ticagrelor Plus Aspirin Followed by Ticagrelor Monotherapy Versus a Current-day Intensive Dual Antiplatelet Therapy in All-comers Patients Undergoing Percutaneous Coronary Intervention With Bivalirudin and BioMatrix Family Drug-eluting Stent Use

Resource links provided by NLM:


Further study details as provided by ECRI bv:

Primary Outcome Measures:
  • Composite of all-cause mortality or non-fatal new Q-wave MI [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
    The composite of all-cause mortality or non-fatal new Q-wave MI up to 2 years post randomisation.


Secondary Outcome Measures:
  • Bleeding [ Time Frame: 2-year ] [ Designated as safety issue: Yes ]
    The composite of investigator-reported BARC3 or BARC5 bleeding according to BARC definitions up to 2 years post randomisation.


Other Outcome Measures:
  • Additional Endpoints [ Time Frame: 2-year ] [ Designated as safety issue: Yes ]
    All-cause mortality

  • Additional Endpoints [ Time Frame: 2-year ] [ Designated as safety issue: Yes ]
    Non-fatal new Q-wave MI

  • Additional Endpoint [ Time Frame: 2-year ] [ Designated as safety issue: Yes ]
    Ischemic stroke, including stroke of undetermined cause

  • Additional Endpoint [ Time Frame: 2-year ] [ Designated as safety issue: Yes ]
    Haemorrhagic stroke

  • Additional Endpoint [ Time Frame: 2-year ] [ Designated as safety issue: Yes ]
    Composite of all-cause mortality, stroke and non-fatal new Q-wave MI

  • Additional Endpoints [ Time Frame: 2-year ] [ Designated as safety issue: Yes ]
    Coronary revascularisation

  • Additional Endpoint [ Time Frame: 2-year ] [ Designated as safety issue: Yes ]
    Definite Stent Thrombosis according to the Academic Research Consortium


Estimated Enrollment: 16000
Study Start Date: May 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental treatment strategy

All patients in the treatment group will receive acetylsalicylic acid (ASA) and ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy.

Dosage and frequency:

Ticagrelor: 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd)

Drug: Ticagrelor
Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.
Other Name: Brilique
Drug: Acetylsalicylic Acid
Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy
Other Names:
  • Aspirin
  • B01AC06
Active Comparator: Reference treatment strategy

Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.

Stable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy.

Dosage and frequency:

Brilique(Ticagrelor): 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd) Clopidogrel: 75 mg qd

Drug: Ticagrelor
Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.
Other Name: Brilique
Drug: Acetylsalicylic Acid
Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy
Other Names:
  • Aspirin
  • B01AC06
Drug: Clopidogrel

Active Comparator: Reference treatment strategy Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.

Stable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy

Other Names:
  • Plavix
  • B01AC04

Detailed Description:

The study objective is to determine in all-comers patients undergoing PCI under standardised treatment (including the BioMatrix family of drug-eluting stents and bivalirudin), whether treatment with 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy is superior with respect to the composite of all-cause mortality or non-fatal new Q-wave MI compared to treatment with 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.

The study design is an investigator-initiated, prospective randomised, multi-centre, multi-national, open-label trial to be conducted in approximately 60-80 interventional cardiology centres in Europe, North America, South America and Asia-Pacific. Patients will be randomised at a 1:1 ratio to study or reference treatment strategy.

Randomisation will occur at the time of the index procedure prior to PCI. Subjects will be stratified according to centre and according to the clinical presentation (Stable Coronary Artery Disease (CAD) vs. Acute Coronary Syndrome (ACS)).

All patients will be followed for a period of 2 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-"All comer" patients

  1. Age ≥18 years;
  2. Presence of one or more coronary artery stenoses of 50% or more in a native coronary artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation. The vessel should have a reference vessel diameter of at least 2.25 mm (no limitation on the number of treated lesions, vessels, or lesion length);
  3. Able to provide informed consent and willing to participate in 2 year follow- up period.

Exclusion Criteria:

  1. Known intolerance to aspirin, P2Y12 inhibitors, bivalirudin, stainless steel or biolimus;
  2. Known intake of a strong CYP3A4 inhibitor (e.g., ketoconazole, clarithromycin, nefazodone, ritonavir, and atazanavir), as co-administration may lead to a substantial increase in exposure to ticagrelor;
  3. Known moderate to severe hepatic impairment (alanine-aminotransferase ≥ 3 x ULN);
  4. Planned surgery, including CABG as a staged procedure (hybrid) within 12 months of the index procedure, unless dual antiplatelet therapy is maintained throughout the peri-surgical period;
  5. Need for chronic oral anti-coagulation therapy;
  6. Active major bleeding or major surgery within the last 30 days;
  7. Known history of intracranial haemorrhagic stroke or intra-cranial aneurysm;
  8. Known stroke (any type) within the last 30 days;
  9. Known pregnancy at time of randomisation;
  10. Female who is breastfeeding at time of randomisation;
  11. Currently participating in another trial and not yet at its primary endpoint.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01813435

Contacts
Contact: Marieke Tuinman, MSc. +31654697953 mtuinman@cardialysis.nl
Contact: Linda Korthout, MSc. +31613230639 lkorthout@cardialysis.nl

  Hide Study Locations
Locations
Australia
Box Hill Hospital Not yet recruiting
Box Hill, Australia
Contact: Gishel New    001161390952441    Gishel.New@easternhealth.org.au   
Contact: Louise Roberts       louise.roberts@easternhealth.org.au   
Principal Investigator: Gishel New, Prof.         
The Prince Charles Hospital Not yet recruiting
Brisbane, Australia
Contact: Christopher Raffel    00617 3139 4711    raffel.c@gmail.com   
Contact: Bernice Enever       Bernice.Enever@health.qld.gov.au;   
Principal Investigator: Christopher Raffel         
St. Vincent's public Not yet recruiting
Melbourne, Australia
Contact: Peter Barlis    03 9928 6370    pbarlis@unimelb.edu.au;   
Contact: Jenny Wilson       Jenny.WILSON@svhm.org.au;   
Principal Investigator: Peter Barlis, Prof.         
The Northern hospital Not yet recruiting
Melbourne, Australia
Contact: Peter Barlis    039928 6370    pbarlis@unimelb.edu.au   
Contact: Jenny Wilson       Jenny.WILSON@svhm.org.au;   
Principal Investigator: Peter Barlis, Prof.         
Royal Perth Hospital Not yet recruiting
Perth, Australia
Contact: Carl Schultz    0061 8 9224 8069    carl.schultz@health.wa.gov.au   
Contact: Michelle Bonner       michelle.bonner@health.wa.gov.au   
Principal Investigator: Carl Schultz, Prof.         
Liverpool Hospital Not yet recruiting
Sydney, Australia
Contact: Sidney Lo    0061287383000    sidneylo_99@yahoo.com   
Contact: Alex Croucher       Alexandria.Croucher@sswahs.nsw.gov.au   
Sub-Investigator: Craig Juergens, Prof.         
Principal Investigator: Sidney Lo         
Austria
Medical University Hospital Graz Recruiting
Graz, Austria
Contact: Robert Zweiker, Prof.    004331638580265    robert.zweiker@medunigraz.at   
Contact: Tanja Odeneg       tanja.odeneg@medunigraz.at   
Principal Investigator: Robert Zweiker         
University Hospital Recruiting
Innsbruck, Austria
Contact: Bernhard Metzler, Prof. MD    43-512-504-81315    Bernhard.Metzler@uki.at   
Principal Investigator: Otmar Pachinger, Prof. MD         
Principal Investigator: Bernhard Metzler, Prof. MD         
General Hospital Linz Recruiting
Linz, Austria
Contact: Clemens Steinwerder, Prof. dr.    4373278066620    clemens.steinwender@akh.linz.at   
Principal Investigator: Clemens Steinwender, Prof. MD         
Wilhelminenspital Recruiting
Vienna, Austria
Contact: Kurt Huber, Prof.    431491505761    kurt.huber@wienkav.at   
Principal Investigator: Kurt Huber, Prof. MD         
University Hospital AKH Recruiting
Vienna, Austria
Contact: Georg Delle Karth, Prof. MD    +4340400 4615    georg.delle-karth@meduniwien.ac.at   
Principal Investigator: Georg Delle Karth, Prof. MD.         
Belgium
CHU de Charleroi Recruiting
Charleroi, Henegouwen, Belgium, 6000
Contact: Adel Aminian, Dr.    +32477676405    adel.aminian@chu-charleroi.be   
Principal Investigator: Adel Amininian, MD.         
Onze Lieve Vrouw Ziekenhuis Recruiting
Aalst, Belgium
Contact: Hedwig Batjoens    +32 53 72 41 68    cardio.studie.aalst@olvz-aalst.be   
Principal Investigator: Emanuel Barbato, MD         
Algemeen Stedelijk Ziekenhuis Recruiting
Aalst, Belgium
Contact: Ian Buysschaert    00 32 53 76 67 30    ian.buysschaert@asz.be;   
Principal Investigator: Ian Buysschaert         
Imelda Ziekenhuis Not yet recruiting
Bonheiden, Belgium
Contact: Luc Janssens, Dr.    3215505140    luc.janssens@imelda.be   
Principal Investigator: Luc Janssens, MD         
ZOL St.Jan Not yet recruiting
Genk, Belgium
Contact: Mathias Vrolix    +3289327100    mathias.vrolix@zol.be   
Principal Investigator: Mathias Vrolix         
Virga Jesse Recruiting
Hasselt, Belgium
Contact: Edouard Benit, Dr.    3211309589    edouard.benit@virgajesse.be   
Principal Investigator: Edouard Benit, Dr.         
Brazil
Instituto Estadual Cardiologia Aloisio de Castro Not yet recruiting
Rio de Janeiro, Brazil
Contact: Edgard Freitas Quintella, MD    +55 21 22462567    e.quintella@gmail.com   
Principal Investigator: Edgard Freitas Quintella, MD         
Instituto Nacional de Cardiologia Not yet recruiting
Rio de Janeiro, Brazil
Contact: sergio martins leandro    +55 21 86261000    sergiom.leandro@hotmail.com   
Principal Investigator: Sergio Leandro         
Hospital Naval Marcílio Suspended
Rio de Janeiro, Brazil
Incor - Hcfmusp Not yet recruiting
Sao Paulo, Brazil
Contact: SELMA CRISTINA QUAIA    +551126615960    selma.quaia@incor.usp.br   
Principal Investigator: P. Lemos, MD         
Instituto Dante Pazzanese de Cardiologia Not yet recruiting
Sao Paulo, Brazil
Contact: Renata Viana    +551150856325    rviana@dantepazzanese.org.br   
Principal Investigator: Amanda Sousa, MD         
Instituo Do Coracao Do Triangulo Mineiro Not yet recruiting
Uberlândia, Brazil
Contact: Silvia Cunha    +553432355207 #31    silvia@ict.med.br   
Principal Investigator: Roberto Botelho, MD         
Bulgaria
Heart Center "Pontica" Not yet recruiting
Burgas, Bulgaria
Contact: Mariana Konteva    00359889580053    konteva@abv.bg   
Contact: Nela Baldjieva       store_pontika@mail.bg   
Principal Investigator: Mariana Konteva         
"St. Ekaterina" university Hospital Not yet recruiting
Sofia, Bulgaria
Contact: Diana Trendafilova-Lazarova    00359895418911    dianalaztr@yahoo.com   
Contact: Nadezhda Hristova       nainadia@yahoo.com   
Principal Investigator: Diana Trendafilova-Lazarova, Assoc. Prof.         
St. Anna Sofia Not yet recruiting
Sofia, Bulgaria
Contact: Vasil Velchev    00 359 899 973015    velchevvasil@gmail.com   
Principal Investigator: Vasil Velchev, Assoc. Prof.         
City Clinic Not yet recruiting
Sofia, Bulgaria
Contact: Ivo Petrov    0035929038639    petrovivo@hotmail.com   
Contact: Lidia Gerassimova       lida.gk@gmail.com   
Principal Investigator: Ivo Petrov, Assoc. Prof.         
Tokuda Hospital Not yet recruiting
Sofia, Bulgaria
Contact: Valeri Gelev    0035888890595    vlgelev@abv.bg   
Principal Investigator: Valeri Gelev         
Alexandrovska hospital Not yet recruiting
Sofia, Bulgaria
Contact: Dobrin Vassilev       dobrinv@gmail.com   
Principal Investigator: Dobrin Vassilev, Prof.         
Canada, Ontario
Southlake Regional Health Centre Not yet recruiting
Newmarket, Ontario, Canada
Contact: Kim Robbins    +9052365966    kim.yorkpci@gmail.com   
Principal Investigator: Sylvain Plante         
Canada
McGill Hospital Withdrawn
Montreal, Canada
Quebec Heart-Lung Institute Not yet recruiting
Quebec, Canada
Contact: Michele Jadin    14186568711 #3007    michele.jadin@criucpq.ulaval.ca   
Principal Investigator: Olivier F. Bertrand, MD         
Denmark
Copenhagen University Hospital - Rigshospitalet Recruiting
Copenhagen, Denmark
Contact: Lene Kløvgaard    0045 3545 1191    lene.kloevgaard@rh.regionh.dk   
Principal Investigator: Lene Holmvang, MD         
Copenhagen University Hospital - Gentofte Withdrawn
Gentofte, Denmark
Roskilde University Hospital Not yet recruiting
Roskilde, Denmark
Contact: Steen Carstensen    0045 28708871    sct@regionsjaelland.dk   
Principal Investigator: Steen Carstensen         
France
Clinique Axium Not yet recruiting
Aix en Provence, France
Contact: Luc Maillard    0033 2 47474655 8775    luc.maillard@laposte.net   
Principal Investigator: Luc Maillard         
Clinique St. Martin Not yet recruiting
Caen, France
Contact: Jean-francois Morelle    0033 2 31 43 30 33    jf.morelle@free.fr   
Principal Investigator: Jean-francois Morelle         
CHU de Caen Not yet recruiting
Caen, France
Contact: Farzin Beygui    0033231063350    farzin.beygui@psl.aphp.fr   
Principal Investigator: Farzin Beygui         
Clinique des Dômes Not yet recruiting
Clermont-Ferrand, France
Contact: Nicolas Caillot, MD    +33680585645    n.caillot@gmail.com   
Principal Investigator: Pascal Barraud         
Clinique de Fontaine Not yet recruiting
Dijon, France
Contact: Philippe Brunel    00338444820    phlppbrunel@gmail.com;   
Principal Investigator: Philippe Brunel         
Groupe Hospitalier Mutualiste de Grenoble Not yet recruiting
Grenoble Cedex, France
Contact: Mohamed Abdellaoui    0033662504047    m.abdellaoui@ghm-grenoble.fr   
Contact: Christophe Dessus       c.dessus@ghm-grenoble.fr;   
Principal Investigator: Mohamed Abdellaoui         
CHRU de Lille - Hopital Cardiologique Not yet recruiting
Lille cedex, France
Contact: Eric van Belle    0033 3 20 44 48 91    ericvanbelle@aol.com   
Contact: Berenice Marchant       berenice.marchant@chru-lille.fr   
Principal Investigator: Eric van Belle         
Hôpital de la Croix-Rousse Not yet recruiting
Lyon, France
Contact: Pierre Lantelme    0033472071066    pierre.lantelme@chu-lyon.fr   
Contact: Cyril Basnard       cyril.besnard@chu-lyon.fr   
Principal Investigator: Pierre Lantelme         
J. Cartier Institut ICPS Withdrawn
Massy, France
Clinique Louis Pasteur Not yet recruiting
Nancy, France
Contact: Michael Angioi    0033 6 61 37 54 03    michaelangioi@gmail.com   
Principal Investigator: Michael Angioi         
Hôpital Bichat Not yet recruiting
Paris, France
Contact: Gabriel STEG, Prof. MD    +33140258669    gabriel.steg@bch.aphp.fr   
Principal Investigator: Gabriel STEG, Prof. MD         
University Hospital Mondor Not yet recruiting
Paris / Creteil, France
Contact: Brigitte Chevalier-Bidaud    +33149 812678    brigitte.chevalier-bidaud@hmn.aphp.fr   
Principal Investigator: Emmanuel Teiger, Prof. MD         
Centre Hospitalier Not yet recruiting
Rouen, France
Contact: Helene Eltchaninoff    0033232888243    Protocole-KT.Cardiologie@chu-rouen.fr   
Contact: Matthieu Godin       Matthieu.Godin@chu-rouen.fr   
Principal Investigator: Helene Eltchaninoff         
Clinique-saint hilaire Not yet recruiting
Rouen, France
Contact: R Koning    0033235086621    rkoning@clinique-sainthilaire.fr   
Principal Investigator: R Koning         
Saint Etienne university hopsital Not yet recruiting
Saint Etienne, France
Contact: Karl Isaaz    0033623398607    karl.isaaz@univ-st-etienne.fr   
Principal Investigator: Karl Isaaz         
Rangueil Hospital Recruiting
Toulouse, France
Contact: JACQUELINE CAHUZAC    +33561323345    cahuzac.j@chu-toulouse.fr   
Principal Investigator: Didier Carrie, Prof. MD         
Clinique Pasteur Withdrawn
Toulouse, France
Germany
Herzzentrum Bad-Krozingen Recruiting
Bad Krozingen, Germany
Contact: Gregor Leibundgut, MD    +4976334024282    gregor.leibundgut@universitaets-herzzentrum.de   
Principal Investigator: Franz-Josef Neumann, Prof. MD         
Kerckhoff Heart Center Recruiting
Bad Nauheim, Germany
Contact: Helge Möllmann, Prof. MD    +4960329962246    h.moellmann@kerckhoff-klinik.de   
Principal Investigator: Helge Möllmann, Prof. MD         
Universitat Bonn Recruiting
Bonn, Germany
Contact: Nikos Werner    004922828713205    nikos.werner@ukb.uni-bonn.de   
Contact: Kaja Twelker       kaja.twelker@ukb.uni-bonn.de   
Principal Investigator: Nikos Werner         
University Hospital Recruiting
Dresden, Germany
Contact: R. H. Strasser, Prof. MD    +493514501330    Ruth.Strasser@tu-dresden.de   
Contact: K. Haacke         
Principal Investigator: R. H. Strasser, Prof. MD         
International Cardiovascular Center Rhein Ruhr Recruiting
Essen, Germany
Contact: Eliasbeth Blank    +4920189786223    e.blank@contilia.de   
Principal Investigator: Christoph Naber, MD         
Elisabeth Krankenhaus Essen Recruiting
Essen, Germany
Contact: Christoph Naber    004920189786223    c.k.naber@contilia.de   
Contact: Elisabeth Blank       e.blank@contilia.de   
Principal Investigator: Christoph Naber         
Klinikum Fulda gAG Recruiting
Fulda, Germany
Contact: Lena Ulbricht    +49661845381    med1.sek@klinikum-fulda.de   
Principal Investigator: Volker Schächinger, Prof. MD         
University of Giessen Recruiting
Giessen, Germany
Contact: Nef, Prof. MD    0049 641 985 56684    holger.nef@me.com   
Principal Investigator: Christiaan Hamm, Prof. MD         
University Hospital Recruiting
Göttingen, Germany
Contact: Wolfgang Schillinger, Prof. MD    +49551396372    schiwolf@med.uni-goettingen.de   
Principal Investigator: Wolfgang Schillinger, Prof. MD         
Klinikum Landshut-Achdorf Recruiting
Landshut, Germany
Contact: U. Zrenner    +49871-404 2149    ute.zrenner@kh-landshut-achdorf.de, andrea.ruehle@kh-landshut-achdorf.de   
Contact: A. Rühle    +49871-404 2177      
Principal Investigator: Bernhard Zrenner, MD         
Universitätsmedizin Mainz Recruiting
Mainz, Germany
Contact: Tommaso Gori    00496131172829    tommaso.gori@unimedizin-mainz.de   
Principal Investigator: Tommaso Gori         
Klinikum Mannheim Recruiting
Mannheim, Germany
Contact: Ibrahim Akin    00493814942012    ibrahim.akin@umm.de   
Principal Investigator: Ibrahim Akin         
Hungary
State Hospital for Cardiology Not yet recruiting
Balatonfüred, Hungary
Contact: Faluközy József    0036302044273    falukozy@elso.bfkor.hu   
Principal Investigator: Faluközy József         
Semmelweis University Not yet recruiting
Budapest, Hungary
Contact: Bela MERKELY    0036209274937    merkely.bela@gmail.com   
Contact: Erika KOLUMBÁN    0036208250511    studycenter.sekk@gmail.com   
Principal Investigator: Bela MERKELY, Prof.         
Gottsegen György (National Health institue) Not yet recruiting
Budapest, Hungary
Contact: Geza Fontos    0036703820358    geza.fontos@gmail.com   
Principal Investigator: Geza Fontos, MD         
University of Debrecen Not yet recruiting
Debrecen, Hungary
Contact: Ferenc Győry    003652411600    gyorydok@gmail.com   
Principal Investigator: Ferenc Győry, MD         
County Hospital Recruiting
Gyula, Hungary
Contact: Zoltán Jambrik    0036206692792    jambrikz@hotmail.com   
Principal Investigator: Zoltán Jambrik         
Szabolcs - Szatmár - Bereg County Hospitals and University Teaching Hospital Not yet recruiting
Nyíregyháza, Hungary
Contact: Zsolt Kőszegi    0036302589442    koszegi@med.unideb.hu   
Principal Investigator: Zsolt Kőszegi         
University of Pécs Not yet recruiting
Pécs, Hungary
Contact: Iván Horváth    003672536000    ivan.g.horvath@aok.pte.hu   
Principal Investigator: Ivan Horváth, MD         
Szegedi Tudományegyetem Not yet recruiting
Szeged, Hungary
Contact: Imre Ungi    0036203323963    ungi.imre@gmail.com   
Contact: Attila Thury    0036302993963    attilathury@gmail.com   
Principal Investigator: Imre Ungi         
Italy
Ospedale S. Donato Recruiting
Arezzo, Italy
Contact: KENNETH DUCCI    575254070    kducci@gmail.com   
Principal Investigator: LEONARDO BOLOGNESE, MD         
Ospedali Civili Not yet recruiting
Brescia, Italy
Contact: salvatore curello    00390303995564    scurello@libero.it   
Principal Investigator: salvatore curello         
Azienda Ospedaliero Universitaria di Ferrara Recruiting
Ferrara, Italy
Contact: Monia Monti    +390532237227    mntmno@unife.it   
Principal Investigator: Marco Valgimigli         
Casa di Cura Montevergine Not yet recruiting
Mercogliano, Italy
Contact: Eugenio Stabile    +39825705130    eugeniostabile@gmail.com   
Principal Investigator: Paulo Rubino, MD         
Niguarda Ca' Not yet recruiting
Milano, Italy
Contact: Silvio Klugmann    00393286242014    silvio.klugmann@ospedaleniguarda.it   
Contact: Francesco Soriano       federico.demarco@ospedaleniguarda.it   
Principal Investigator: Silvio Klugmann         
San Raffaele Recruiting
Milano, Italy
Contact: angela ferrari    +390226437331    ferrari.angela@hsr.it   
Principal Investigator: Antonio Colombo, MD         
Laboratorio Emodinamica Recruiting
Pavia, Italy
Contact: Umberto Canosi    +390382503739    laboratorio.emodinamica@smatteo.pv.it   
Principal Investigator: Ezio Bramucci, MD         
Azienda Ospedaliera S. Maria Recruiting
Terni, Italy
Contact: Marcello Dominici, Prof. MD    +393299039039    md.dominici@gmail.com   
Principal Investigator: Marcello Dominici, Prof. MD         
Netherlands
Erasmus Medisch Centrum Recruiting
Rotterdam, Zuid Holland, Netherlands, 3015 CE
Contact: RJ van Geuns, MD    0031-10-7032891    r.vangeuns@erasmusmc.nl   
Principal Investigator: R. van Geuns, MD         
Medisch Centrum Alkmaar Recruiting
Alkmaar, Netherlands
Contact: V Umans, MD    +31725484444    v.umans@mca.nl   
Principal Investigator: V Umans, MD         
OLVG Recruiting
Amsterdam, Netherlands
Contact: T Slagboom, MD    +31205994824    T.Slagboom@OLVG.nl   
Principal Investigator: T Slagboom, MD         
University Medical Centre Groningen Active, not recruiting
Groningen, Netherlands
Medisch Centrum Leeuwarden Recruiting
Leeuwarden, Netherlands
Contact: Metske van der Wal    31582863123    metske.wal@znb.nl   
Principal Investigator: A.J. van Boven, MD         
St. Antonius Ziekenhuis Recruiting
Nieuwegein, Netherlands
Contact: Benno Rensing    0031306092274    b.rensing@wxs.nl; b.rensing@antonius.net   
Contact: Mike Bosschaert       m.bosschaert@antoniusziekenhuis.nl   
Principal Investigator: Benno Rensing         
UMC St Radboud Recruiting
Nijmegen, Netherlands
Contact: Harry Suryapranata, Prof. MD    +31611759514    h.suryapranata@cardio.umcn.nl   
Principal Investigator: Harry Suryapranata, Prof. MD         
Maasstad Recruiting
Rotterdam, Netherlands
Contact: Ria van Vliet    +31102913278    VlietM@maasstadziekenhuis.nl   
Principal Investigator: Kees-Jan Royaards, MD         
TweeSteden Ziekenhuis Recruiting
Tilburg, Netherlands
Contact: Michael Magro    0031645133546    mmagro@tsz.nl   
Principal Investigator: Michael Magro         
Poland
PAKS Chrzanów Recruiting
Chrzanow, Poland
Contact: Aleksander Zurakowski, MD    +48605 336127    olekzurakowski@gmail.com   
Principal Investigator: Aleksander Zurakowski, MD         
PAKS Dabrowa Recruiting
Dabrowa Gornicza, Poland
Contact: Dagmara Oleksiak    +48327642724    d.oleksiak@klinikiserca.pl   
Principal Investigator: Paweł Buszman, MD         
PAKS Kozle Recruiting
Kedzierzyn-Kozle, Poland
Contact: Grażyna Zalewska    +48774722565    g.zalewska@klinikiserca.pl   
Principal Investigator: Janusz Prokopczuk         
JP2 Recruiting
Krakov, Poland
Contact: Jaroslaw Trebacz    +48504299395    jtrebacz@szpitaljp2.krakow.pl   
Principal Investigator: Krzysztof Żmudka, MD         
V Oddzial Kardiologii Inwazyjnej i Angiologii Recruiting
Mielec, Poland
Contact: Adam Młodziankowski    0048 017 7800346    b.piatek@klinikiserca.pl   
Principal Investigator: Adam Młodziankowski         
Nyskie Centrum Kardiologii Recruiting
Nysa, Poland
Contact: Paweł Jasionowicz    0048774091443    pjasi@mp.pl   
Principal Investigator: Paweł Jasionowicz, MD         
University Hospital Not yet recruiting
Poznan, Poland
Contact: Andrzej Dreawnicki    +48618549223    drewnicki@o2.pl   
Principal Investigator: Maciej Lesiak, MD         
PAKS Ustron Recruiting
Ustroń, Poland
Contact: Marek Król, MD    +48338545857    drkrol@gmail.com   
Principal Investigator: Marek Król, MD         
Insitute of Cardiology Not yet recruiting
Warsaw, Poland
Contact: Maciej Dąbrowski, MD    +48223434267    macidabro@yahoo.com   
Principal Investigator: Adam Witkowski, MD         
Romania
Spitalul Clinic de Urgenta Bucuresti Not yet recruiting
Bucuresti, Romania
Contact: Dorobantu Maria    0040744366220    maria.dorobantu@gmail.com   
Contact: Rodica Niculescu       rdcniculescu@gmail.com   
Principal Investigator: Rodica Niculescu, Prof.         
Institutul de Boli Cardiovasculare C.C. Iliescu Not yet recruiting
Bucuresti, Romania
Contact: Dan Deleanu    0040722794061    dan.deleanu@yahoo.com   
Principal Investigator: Dan Deleanu         
University hospital Not yet recruiting
Cluj - Napoca, Romania
Contact: Adrian Iancu    0040744751027    adrian_iancu@hotmail.com   
Principal Investigator: adrian iancu         
Judetean County Emergency Hospital Cluj Not yet recruiting
Cluj-Napoca, Romania
Contact: Dan Olinic    0040745397328    dolinic@yahoo.com   
Principal Investigator: Dan Olinic, Assoc. Prof.         
Singapore
National Heart Center Recruiting
Singapore, Singapore
Contact: Florence    +6564367686    florence.ang.s.c@nhcs.com.sg   
Principal Investigator: Tian Hai Koh, MD         
Tan Tock Seng Hospital Recruiting
Singapore, Singapore
Contact: Paul Ong, MD    +6563577831    paul_jl_ong@ttsh.com.sg   
Principal Investigator: Paul Ong, MD         
Spain
Sant Pau i Santa Creu Recruiting
Barcelona, Spain
Contact: Juan García-Picart    +34935565851    jgarciapi@santpau.cat   
Principal Investigator: Antonio Serra Peñaranda, MD         
Clinic University Hospital Barcelona Recruiting
Barcelona, Spain
Contact: Eva Trelliso    +34932279305    etrelliso@clinic.ub.es   
Principal Investigator: Manel Sabate, MD         
H. Bellvitge Recruiting
Barcelona, Spain
Contact: Sonia Guerrero    +34932607229    sonia.guerrero.moreno@gmail.com   
Principal Investigator: Angel Cequier, MD         
Hosp Juan Ramon Jiminez Not yet recruiting
Huelva, Spain
Contact: Dr. Jose Francisco Diaz       josefrancisco.diaz.fernandez@sacardiologia.com;   
Contact: Ana Diaz       dr1977@hotmail.com   
Principal Investigator: Jose Francisco Diaz         
Hospital 12 Octobre Recruiting
Madrid, Spain
Contact: ALFONSO JURADO    +34913908440    alfonjroman@hotmail.com   
Principal Investigator: AGUSTIN ALBARRAN GONZALEZ-TREVILLA, MD         
Clinico Universitario San Carlos Recruiting
Madrid, Spain
Contact: Antonio Fernandez Ortiz    +34 913303289    afernandez.hcsc@salud.madrid.org   
Principal Investigator: Carlos Macaya Miguel, MD         
H Ramon y Cajal-Madrid Recruiting
Madrid, Spain
Contact: Rosa Ana ernandez Antolin    0034 617703434    rhernandez_antolin@hotmail.com   
Principal Investigator: Rosa Ana Hernandez Antolin         
Hospital Puerta de Hierro Recruiting
Madrid, Spain
Contact: Javier Goicolea       j_goicolea@hotmail.com   
Contact: Juan Francisco Oteo       jfoteod@hotmail.com   
Principal Investigator: Javier Goicolea         
H. Marques de Valdecilla Santander Suspended
Santander, Spain
Hospital Meixoeiro Recruiting
Vigo, Spain
Contact: Carlos Diaz    +34986811163    carlos.maria.diaz.lopez@sergas.es   
Principal Investigator: Andres Iñiguez, MD         
Sweden
Uppsala University Hospital Withdrawn
Uppsala, Sweden
Switzerland
Tiefenauspital Not yet recruiting
Bern, Switzerland
Contact: Aris Moschovitis    0041313088690    aris.moschovitis@insel.ch   
Principal Investigator: Aris Aris Moschovitis         
University Hospital Recruiting
Bern, Switzerland
Contact: Stephan Windecker, Prof. MD    +41316324497    stephan.windecker@insel.ch   
Principal Investigator: Stephan Windecker, Prof. MD         
HUG Recruiting
Geneva, Switzerland
Contact: Marco Roffi, MD    +41 22 37 23 743    marco.roffi@hcuge.ch   
Principal Investigator: Marco Roffi, Prof. MD         
CHUV Recruiting
Lausanne, Switzerland
Contact: nathalie Lauriers    41795560618    nathalie.lauriers@chuv.ch   
Principal Investigator: Eric Eeckhout, Prof. MD         
CardioCentro Ticino Recruiting
Lugano, Switzerland
Contact: Rossi M Grazia    +41918053055    src@cardiocentro.org   
Principal Investigator: Tiziano Moccetti, Prof. MD         
University Hospital Withdrawn
Zürich, Switzerland
United Kingdom
Belfast Trust Not yet recruiting
Belfast, United Kingdom
Contact: Simon Walsh    00442895048229    simon.walsh@belfasttrust.hscni.net   
Principal Investigator: Simon Walsh         
Royal Blackburn Hospital Recruiting
Blackburn, United Kingdom
Contact: Scot Garg    +447977408384    scot.garg@elht.nhs.uk   
Principal Investigator: Scot Garg         
LANCASHIRE HEART CENTRE, Victoria Hospital Recruiting
Blackpool, United Kingdom
Contact: Gavin Galasko, MD    +44 1253 657761    dr.galasko@bfwhospitals.nhs.uk   
Principal Investigator: Gavin Galasko, MD         
Royal Sussex County Hospital Recruiting
Brighton, United Kingdom
Contact: Nina Cooter    01273 696955    nina.cooter@bsuh.nhs.uk   
Principal Investigator: Daivd Hildick-Smith, MD         
Bristol Heart Institute Recruiting
Bristol, United Kingdom
Contact: Andreas Baumbach, MD    +1173426573    andreas.baumbach@uhbristol.nhs.uk   
Principal Investigator: Andreas Baumbach, MD         
Universtiy Hospital of Wales Recruiting
Cardiff, United Kingdom
Contact: Richard Anderson, MD    02920 743786    Richard.Anderson@wales.nhs.uk   
Principal Investigator: Richard Anderson, MD         
Golden Jubilee National Hospital Recruiting
Glasgow, United Kingdom
Contact: Keith G Oldroyd, MD    0141 951 5180    keith.oldroyd@nhs.net   
Principal Investigator: Keith G. Oldroyd, MD         
Liverpool Heart and Chest Hospital Recruiting
Liverpool, United Kingdom
Contact: Rod Stables, MD    +44 151 600 1489    rod.stables@LHCH.nhs.Uk   
Principal Investigator: Rod Stables, MD         
Manchester Royal Infirmary Recruiting
Manchester, United Kingdom
Contact: Heather Iles-Smith    +1612767958    Heather.Iles-smith@cmft.nhs.uk   
Principal Investigator: Mamas Mamas, MD         
South Manchester University Hospital Recruiting
Manchester, United Kingdom
Contact: Diane Daniel    +44 161 291 4650    diane.daniel@uhsm.nhs.uk   
Principal Investigator: Saqib Chowdhary, MD         
Freeman Hospital Not yet recruiting
Newcastle, United Kingdom
Contact: Azfar Zaman    0044 191 2448939    azfar.zaman@nuth.nhs.uk   
Contact: Samantha Jones       samantha.jones@nuth.nhs.uk   
Principal Investigator: Azfar Zaman         
Portsmouth Hospitals NHS Trust Not yet recruiting
Portsmouth, United Kingdom
Contact: Philip Strike    0044 2302286000    philip.strike@porthosp.nhs.uk   
Contact: Alison Moore    023 9236 5010    amppsec@gmail.com   
Principal Investigator: Philip Strike         
New Cross Hospital Not yet recruiting
Wolverhampton, United Kingdom
Contact: James Cotton    01902 695063    jamescotton@nhs.net   
Contact: Andy Smallwood       andy.smallwood@nhs.net   
Principal Investigator: James Cotton         
Sponsors and Collaborators
ECRI bv
Biosensors International
AstraZeneca
The Medicines Company
Investigators
Study Chair: Patrick Serruys, Prof. MD. Thoraxcenter, Erasmus, The Netherlands
Principal Investigator: Marco Valgimigli, MD Universitaria di Ferrara, Italy
Principal Investigator: Pascal Vranckx, MD UZ Virga Jesse Ziekenhuis, Belgium
Principal Investigator: Stephan Windecker, Prof. MD Inselspital, University Hospital Bern Switzerland
Principal Investigator: Christian Hamm, Prof. MD Kerckhoff Klinik GmbH, Germany
Principal Investigator: Peter Juni, Prof. MD Bern University Hospital, Switzerland
Principal Investigator: Gabriel Steg, Prof. MD. C.H.U. Bichat - Claude Bernard, France
Study Director: Gerrit-Anne van Es ECRI, the Netherlands
  More Information

No publications provided

Responsible Party: ECRI bv
ClinicalTrials.gov Identifier: NCT01813435     History of Changes
Other Study ID Numbers: ECRI-12-001, 02EU11
Study First Received: February 12, 2013
Last Updated: September 14, 2014
Health Authority: Australia: Human Research Ethics Committee
Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: National Health Surveillance Agency
Bulgaria: Ministry of Health
Canada: Health Canada
Denmark: Danish Health and Medicines Authority
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Italy: The Italian Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Singapore: Health Sciences Authority
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by ECRI bv:
CAD
ACS
All comers
DAPT
PCI

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aspirin
Clopidogrel
Ticagrelor
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics

ClinicalTrials.gov processed this record on September 18, 2014