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 October 2013 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: October 12, 2013
Last verified: October 2013
  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. 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
Austria
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 Not yet recruiting
Linz, Austria
Contact: Clemens Steinwerder, Prof. dr.    4373278066620    clemens.steinwender@akh.linz.at   
Principal Investigator: Clemens Steinwender, Prof. MD         
University Hospital AKH Not yet recruiting
Vienna, Austria
Contact: Georg Delle Karth, Prof. MD    +4340400 4615    georg.delle-karth@meduniwien.ac.at   
Principal Investigator: Georg Delle Karth, Prof. MD.         
Wilhelminenspital Recruiting
Vienna, Austria
Contact: Kurt Huber, Prof.    431491505761    kurt.huber@wienkav.at   
Principal Investigator: Kurt Huber, 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         
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 Not yet recruiting
Rio de Janeiro, Brazil
Contact: MARIA CRISTINA MEIRA FERREIRA, MD    +552125995455    macrisferreira@uol.com.br   
Principal Investigator: "MARIA CRISTINA MEIRA FERREIRA, MD         
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         
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 Not yet recruiting
Montreal, Canada
Contact: Kathleen Amedee    514 843-1502    kathleen.amedee@muhc.mcgill.ca   
Principal Investigator: Luc Bilodeau, MD         
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 Not yet recruiting
Copenhagen, Denmark
Contact: Lene Kløvgaard    0045 3545 1191    lene.kloevgaard@rh.regionh.dk   
Principal Investigator: Lene Holmvang, MD         
Copenhagen University Hospital - Gentofte Not yet recruiting
Gentofte, Denmark
Contact: Soeren Galatius, MD    +4521638907    soga@regionh.dk   
Principal Investigator: Soeren Galatius, MD         
France
Clinique des Dômes Not yet recruiting
Clermont-Ferrand, France
Contact: Nicolas Caillot, MD    +33680585645    n.caillot@gmail.com   
Principal Investigator: Janusz Lipiecki, MD         
J. Cartier Institut ICPS Not yet recruiting
Massy, France
Contact: L. MORSIANI    +331 69 85 50 89    l.morsiani@icps.com.fr   
Principal Investigator: Marie-Claude Morice, MD         
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         
Rangueil Hospital Not yet recruiting
Toulouse, France
Contact: JACQUELINE CAHUZAC    +33561323345    cahuzac.j@chu-toulouse.fr   
Principal Investigator: Didier Carrie, Prof. MD         
Clinique Pasteur Not yet recruiting
Toulouse, France
Contact: Frédéric PETIT    +33562211699    f.petit@clinique-pasteur.com   
Principal Investigator: Jean FAJADET, MD         
Germany
Herzzentrum Bad-Krozingen Not yet 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         
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         
Klinikum Fulda gAG Recruiting
Fulda, Germany
Contact: Lena Ulbricht    +49661845381    med1.sek@klinikum-fulda.de   
Principal Investigator: Volker Schächinger, Prof. MD         
University of Giessen Not yet 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         
Italy
Ospedale S. Donato Recruiting
Arezzo, Italy
Contact: KENNETH DUCCI    575254070    kducci@gmail.com   
Principal Investigator: LEONARDO BOLOGNESE, MD         
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         
San Raffaele Not yet recruiting
Milano, Italy
Contact: angela ferrari    +390226437331    ferrari.angela@hsr.it   
Principal Investigator: Antonio Colombo, MD         
Laboratorio Emodinamica Not yet recruiting
Pavia, Italy
Contact: Umberto Canosi    +390382503739    laboratorio.emodinamica@smatteo.pv.it   
Principal Investigator: Ezio Bramucci, MD         
Azienda Ospedaliera S. Maria Not yet 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         
Medisch Centrum Leeuwarden Not yet recruiting
Leeuwarden, Netherlands
Contact: Metske van der Wal    31582863123    metske.wal@znb.nl   
Principal Investigator: A.J. van Boven, MD         
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         
Poland
PAKS Chrzanów Recruiting
Chrzanow, Poland
Contact: Aleksander Zurakowski, MD    +48605 336127    olekzurakowski@gmail.com   
Principal Investigator: Aleksander Zurakowski, MD         
PAKS Dabrowa Not yet 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 Not yet recruiting
Krakov, Poland
Contact: Jaroslaw Trebacz    +48504299395    jtrebacz@szpitaljp2.krakow.pl   
Principal Investigator: Krzysztof Żmudka, MD         
University Hospital Not yet recruiting
Poznan, Poland
Contact: Andrzej Dreawnicki    +48618549223    drewnicki@o2.pl   
Principal Investigator: Maciej Lesiak, MD         
PAKS Ustron Not yet 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         
Singapore
National Heart Center Not yet recruiting
Singapore, Singapore
Contact: Florence    +6564367686    florence.ang.s.c@nhcs.com.sg   
Principal Investigator: Tian Hai Koh, MD         
Tan Tock Seng Hospital Not yet 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         
Clinico Universitario San Carlos Recruiting
Madrid, Spain
Contact: Antonio Fernandez Ortiz    +34 913303289    afernandez.hcsc@salud.madrid.org   
Principal Investigator: Carlos Macaya Miguel, MD         
Hospital 12 Octobre Recruiting
Madrid, Spain
Contact: ALFONSO JURADO    +34913908440    alfonjroman@hotmail.com   
Principal Investigator: AGUSTIN ALBARRAN GONZALEZ-TREVILLA, MD         
H. Marques de Valdecilla Santander Not yet recruiting
Santander, Spain
Contact: Javier Zueco, MD    +34942202744    jzueco@humv.es   
Principal Investigator: Javier Zueco, MD         
Hospital Meixoeiro Recruiting
Vigo, Spain
Contact: Carlos Diaz    +34986811163    carlos.maria.diaz.lopez@sergas.es   
Principal Investigator: Andres Iñiguez, MD         
Sweden
Uppsala University Hospital Recruiting
Uppsala, Sweden
Contact: Stefan James, MD    +46705944404    stefan.james@ucr.uu.se   
Principal Investigator: Stefan James, MD         
Switzerland
University Hospital Not yet 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 Recruiting
Zürich, Switzerland
Contact: Ines Bühler    +41442553049    ines.buehler@usz.ch   
Principal Investigator: R. Binder, MD         
United Kingdom
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         
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         
Manchester Royal Infirmary Recruiting
Manchester, United Kingdom
Contact: Heather Iles-Smith    +1612767958    Heather.Iles-smith@cmft.nhs.uk   
Principal Investigator: Mamas Mamas, MD         
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: October 12, 2013
Health Authority: Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: National Health Surveillance Agency
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
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 July 26, 2014