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Evaluation of Dual Therapy With Dabigatran vs. Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting (REDUAL-PCI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02164864
Recruitment Status : Completed
First Posted : June 17, 2014
Results First Posted : July 31, 2018
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:

The main objective of this study is to compare a Dual Antithrombotic Therapy (DAT) regimen of 110mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (110mg dabigatran etexilate (DE) DAT) and 150mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (150mg DE-DAT) with a Triple Antithrombotic Therapy (TAT) combination of warfarin plus clopidogrel or ticagrelor plus Aspirin (ASA) <= 100mg once daily (warfarin-TAT) in patients with Atrial Fibrillation that undergo a PCI with stenting (elective or due to an Acute Coronary Syndrome).

The study aims to show non-inferiority of each dose of DE-DAT when compared to Warfarin-TAT in terms of safety. Safety will be determined by comparing the rates of bleeding events, assessed using the modified International Society of Thrombosis and Haemostasis classification of Major Bleeding and Clinically Relevant Non Major Bleeding Events.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Percutaneous Coronary Intervention Drug: Dabigatran Etexilate 110mg Drug: Warfarin 3mg Drug: Aspirin Drug: Dabigatran Etexilate 150mg Drug: Clopidogrel or Ticagrelor Drug: Warfarin 5mg Drug: Warfarin 1mg Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2725 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomised, Open Label, Blinded Endpoint (PROBE) Study to Evaluate DUAL Antithrombotic Therapy With Dabigatran Etexilate (110mg and 150mg b.i.d.) Plus Clopidogrel or Ticagrelor vs. Triple Therapy Strategy With Warfarin (INR 2.0 - 3.0) Plus Clopidogrel or Ticagrelor and Aspirin in Patients With Non Valvular Atrial Fibrillation (NVAF) That Have Undergone a Percutaneous Coronary Intervention (PCI) With Stenting
Actual Study Start Date : July 22, 2014
Actual Primary Completion Date : June 5, 2017
Actual Study Completion Date : June 5, 2017


Arm Intervention/treatment
Experimental: Dabigatran Etexilate 110mg
Patient to receive Dabigatran Etexilate 110mg twice a day (BID)
Drug: Dabigatran Etexilate 110mg
Active treatment

Drug: Clopidogrel or Ticagrelor
Active comparator

Experimental: Dabigatran Etexilate 150mg
Patient to receive Dabigatran Etexilate 150mg twice a day (BID)
Drug: Dabigatran Etexilate 150mg
Active treatment

Drug: Clopidogrel or Ticagrelor
Active comparator

Active Comparator: Warfarin
Warfarin doses to maintain INR
Drug: Warfarin 3mg
Active comparator

Drug: Aspirin
Active comparator

Drug: Clopidogrel or Ticagrelor
Active comparator

Drug: Warfarin 5mg
Active comparator

Drug: Warfarin 1mg
Active comparator




Primary Outcome Measures :
  1. Time to First Adjudicated ISTH MBE or CRNMBE [ Time Frame: up to 30 months ]

    Time to event analysis of patients with first adjudicated International Society of Thrombosis and Haemostasis (ISTH) Major Bleeding Event (MBE) or Clinically Relevant Non Major Bleeding Event (CRNMBE). The number of observed patients with adjudicated ISTH MBE or CRNMBE was reported.

    Full analysis set (FAS): All consenting patients randomised were analysed in the treatment group to which they were randomised regardless of whether they took trial medication. The start date of the observation period for this analysis set was the date of randomisation. Patients who discontinued trial medication were followed until the end of the trial.

    Patients who were lost to follow-up for vital status were censored for the primary endpoint at the time of their last known vital status.

    Intention to treat period: The observation period for these analysis was the so called 'intention to treat period'.



Secondary Outcome Measures :
  1. Time to Adjudicated Undetermined Cause of Death [ Time Frame: up to 30 months ]

    Time to event analysis of patients with adjudicated Undetermined cause of death. The number of observed patients with adjudicated Undetermined cause of death was reported.

    This is referred to a death not attributable to cardiovascular (CV) death or to a non-cardiovascular (non-CV) cause. Inability to classify the cause of death may have been due to lack of information (e.g. the only available information was "patient died") or when there was insufficient supporting information or detail to assign the cause of death.


  2. Time to Adjudicated Non-CV [ Time Frame: up to 30 months ]

    Time to event analysis of patients with adjudicated Non-cardiovascular (Non-CV). The number of observed patients with adjudicated Non-CV was reported.

    Non-CV death was defined as any death with a specific cause that was not thought to be CV. These were possible examples of non-CV causes of death: Pulmonary, Renal, Gastrointestinal, Hepatobiliary, Pancreatic Infection(included sepsis), Inflammatory (e.g. systemic inflammatory response syndrome) or immune (including autoimmune), Haemorrhage that was neither CV bleeding nor a stroke, Non-CV procedure or surgery, Trauma, Suicide, Non-prescription drug reaction or overdose, Prescription drug reaction or overdose, Neurological (non-CV), Malignancy, Other non-CV


  3. Time to Adjudicated CV [ Time Frame: up to 30 months ]

    Time to event analysis of patients with adjudicated Cardiovascular (CV) death. The number of observed patients with adjudicated Cardiovascular (CV) death was reported.

    CV death included death resulting from an acute myocardial infarction, sudden cardiac death, death due to heart failure, death due to stroke, death due to CV procedures, death due to CV haemorrhage, and death due to other CV causes.


  4. Time to Adjudicated All Cause Death [ Time Frame: up to 30 months ]
    Time to event analysis of patients with adjudicated all cause death. The number of observed patients with adjudicated all cause death was reported. All cause death is defined as the death from any cause included CV death, non-CV death, and undetermined cause of death.

  5. Time to First Adjudicated MI [ Time Frame: up to 30 months ]
    Time to event analysis of patients with first adjudicated Myocardial Infarction (MI). The number of observed patients with adjudicated MI was reported

  6. Time to First Adjudicated Stroke [ Time Frame: up to 30 months ]

    Time to event analysis of patients with first adjudicated Stroke. The number of observed patients with adjudicated Stroke was reported.

    Stroke was defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of haemorrhage or infarction


  7. Time to First Adjudicated SE [ Time Frame: up to 30 months ]

    Time to event analysis of patients with first adjudicated Systemic embolism (SE). The number of observed patients with adjudicated SE was reported.

    SE is an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts) and had to be documented by angiography, surgery, scintigraphy, or autopsy.


  8. Time to First Adjudicated ST [ Time Frame: up to 30 months ]
    Time to event analysis of patients with first adjudicated Stent Thrombosis (ST). The number of observed patients with adjudicated ST was reported.

  9. Time to Composite Endpoint of Death + MI + Stroke [ Time Frame: up to 30 months ]
    Time to event analysis of patients with the composite endpoint of death + myocardial infarction (MI) + stroke. The number of observed patients with the composite endpoint of death + myocardial infarction (MI) + stroke was reported.

  10. Time to Composite Endpoint of Death or First Thrombotic Event [ Time Frame: up to 30 months ]
    Time to event analysis of patients with composite endpoint of death or first thrombotic event (all death, myocardial infarction (MI), stroke/systemic embolism (SE)). The number of observed patients with composite endpoint of death or thrombotic event (all death, MI, stroke/SE).

  11. Time to First Adjudicated Unplanned Revascularisation by PCI/CABG [ Time Frame: up to 30 months ]
    Time to event analysis of patients with adjudicated unplanned revascularisation by Percutaneous Coronary Intervention (PCI)/Coronary Artery Bypass Graft (CABG). The number of observed patients with adjudicated unplanned revascularisation by PCI/CABG was reported.

  12. Time to Death or First Thrombotic Event or Unplanned Revascularisation by PCI/CABG [ Time Frame: up to 30 months ]
    Time to event analysis of patients with death or thrombotic event (all death, myocardial infarction, stroke/systemic embolism) or unplanned revascularisation by Percutaneous Coronary Intervention/Coronary Artery Bypass Graft. The number of observed patients with death or first thrombotic event or unplanned revascularisation by PCI/CABG was reported.



Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Male or female patients aged >=18 years
  • Patients with Non Valvular Atrial Fibrillation
  • Patient presenting with:

An Acute Coronary Syndrome (ACS) (ST elevation myocardial infarction (STEMI), NonSTEMI [NSTEMI] or unstable angina [UA]) that was successfully treated by PCI and stenting (either Bare Metal Stent (BMS) or Drug Eluting Stent) Or Stable Coronary Artery Disease with at least one lesion eligible for PCI that was successfully treated by elective PCI and stenting (either BMS or DES)

  • The patient must be able to give informed consent in accordance with International Conference on Harmonisation Good Clinical Practice guidelines and local legislation and/or regulations.

Exclusion criteria:

  • Patients with a mechanical or biological heart valve prosthesis
  • Cardiogenic shock during current hospitalisation
  • Stroke within 1 month prior to screening visit
  • Patients who have had major surgery within the month prior to screening
  • Gastrointestinal haemorrhage within one month prior to screening, unless, in the opinion of the Investigator, the cause has been permanently eliminated
  • Major bleeding episode including life-threatening bleeding episode in one month prior to screening visit
  • Anaemia (haemoglobin <10g/dL) or thrombocytopenia including heparin-induced thrombocytopenia (platelet count <100 x 109/L) at screening
  • Severe renal impairment (estimated Creatinine Clearance (CrCl) calculated by Cockcroft-Gault equation) <30mL/min at screening
  • Active liver disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02164864


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Locations
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United States, Alabama
Cardiology P.C.
Birmingham, Alabama, United States, 35211
United States, Arizona
Verde Valley Medical Center
Cottonwood, Arizona, United States, 86326
Cardiovascular Associates of Mesa
Mesa, Arizona, United States, 85206
HonorHealth Research Institute
Scottsdale, Arizona, United States, 85258
United States, Arkansas
Arkansas Cardiology, PA
Little Rock, Arkansas, United States, 72205
United States, California
Mission Cardiovascular Research Institute
Fremont, California, United States, 94538
United States, Colorado
Aurora Denver Cardiology Associates, PC
Aurora, Colorado, United States, 80012
United States, Florida
University of Florida College of Medicine
Jacksonville, Florida, United States, 32209
Watson Clinic, LLP
Lakeland, Florida, United States, 33805
United States, Indiana
Community Clinical Research Center
Anderson, Indiana, United States, 46011
Midwest Cardiovascular Research and Education Foundation
Elkhart, Indiana, United States, 46514
Ball Memorial Hospital
Muncie, Indiana, United States, 47303
Richmond Cardiology Associates Research, LLC
Richmond, Indiana, United States, 47374
United States, Louisiana
Cardiovascular Institute of the South
Houma, Louisiana, United States, 70360
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Cape Cod Research Institute
Hyannis, Massachusetts, United States, 02601
United States, Michigan
Mid Michigan Medical Center
Midland, Michigan, United States, 48670
Covenant Medical Center, Inc.
Saginaw, Michigan, United States, 48602
United States, Minnesota
Saint Mary's Medical Center dba Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, United States, 55805
CentraCare Heart and Vascular Center
Saint Cloud, Minnesota, United States, 56303
United States, Missouri
Kansas City Veterans Administration Medical Center
Kansas City, Missouri, United States, 64128
Saint Anthony's Medical Center
Saint Louis, Missouri, United States, 63128
United States, New Jersey
St. Michaels Medical Center
Newark, New Jersey, United States, 07102
Lourdes Cardiology Services
Voorhees, New Jersey, United States, 08043
United States, New York
VA Western New York Healthcare System
Buffalo, New York, United States, 14215
United States, North Carolina
Novant Health Heart and Vascular Institute
Charlotte, North Carolina, United States, 28204
United States, North Dakota
Altru Health System
Grand Forks, North Dakota, United States, 58201
United States, Ohio
Cardiovascular Research Center
Toledo, Ohio, United States, 43608
United States, Pennsylvania
Chambersburg Hospital
Chambersburg, Pennsylvania, United States, 17201
Pinnacle Health Harrisburg Hospital
Harrisburg, Pennsylvania, United States, 17101
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, Tennessee
Chattanooga Heart Institute
Chattanooga, Tennessee, United States, 37404
The Jackson Clinic, PA
Jackson, Tennessee, United States, 38301
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-8802
United States, Texas
Dallas VA Medical Center
Dallas, Texas, United States, 75216
North Dallas Research Associates
McKinney, Texas, United States, 75069
Scott and White Healthcare
Round Rock, Texas, United States, 78665
South Texas Cardiovascular Consultants
San Antonio, Texas, United States, 78201
Wichita Falls Heart Clinic
Wichita Falls, Texas, United States, 76301
United States, Utah
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84132
United States, Virginia
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Bayview Physicians Services PC dba Cardiovascular Associates
Virginia Beach, Virginia, United States, 23454
United States, Wisconsin
Holy Family Memorial, Inc
Manitowoc, Wisconsin, United States, 54220
Argentina
Fundación Favaloro
Caba, Argentina, C1093AAS
Hospital Italiano de Buenos Aires
Caba, Argentina, C1199ABB
Instituto Cardiovascular de Buenos Aires
Caba, Argentina, C1428DCO
Consultorios Asociados de Endocrinología e Invest Clínica
Capital Federal, Argentina, C1425AGC
Instituto de Cardiología de Corrientes
Corrientes, Argentina, W3400AMZ
Sanatorio Allende
Córdoba, Argentina, X5000BFB
Instituto CER
Quilmes, Argentina, B1878DVB
Inst.Cardiovascular San Luis
San Luis, Argentina, D5702JRS
Investigaciones Clinicas Tucumán
San Miguel de Tucumán, Argentina, T4000ICL
Australia, New South Wales
Pendlebury Research
Adamstown, New South Wales, Australia, 2289
Gosford Hospital
Gosford, New South Wales, Australia, 2250
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
Wollongong Hospital
Wollongong, New South Wales, Australia, 2500
Australia, Queensland
The Prince Charles Hospital
Chermside, Queensland, Australia, 4032
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Heartcare Victoria
Bundoora, Victoria, Australia, 3083
The Geelong Hospital
Geelong, Victoria, Australia, 3220
Austria
Order Hospital Elisabethinen Linz
Linz, Austria, 4020
LKH Salzburg, Univ. Clinic
Salzburg, Austria, 5020
Wilhelminenspital
Wien, Austria, 1160
Belgium
Aalst - HOSP Onze-Lieve-Vrouw
Aalst, Belgium, 9300
Bonheiden - HOSP Imelda
Bonheiden, Belgium, 2820
Brussels-UNIV Brugmann -Horta
Brussel, Belgium, 1020
Brussels - UNIV UZ Brussel
Brussel, Belgium, 1090
AZ Sint-Lucas - Campus Sint Lucas
Gent, Belgium, 9000
Charleroi - HOSP St-Joseph
Gilly, Belgium, 6060
Ziekenhuis Netwerk Antwerpen (ZNA) - Campus Middelheim
Middelheim, Belgium, 2020
Sint-Niklaas - HOSP AZ Nikolaas (Campus St-Niklaas)
Sint-Niklaas, Belgium, 9100
Tienen - PRAC De Wolf, Axel
Tienen, Belgium, 3300
Brussels - HOSP Europe (Ste-Elisabeth)
Ukkel, Belgium, 1180
Brazil
Hospital Santa Isabel
Blumenau, Brazil, 89010-500
Irmandade da Santa Casa de Misericordia de Curitiba
Campina Grande do Sul, Brazil, 83430-000
Instituto de Cardiologia Rio Grande do Sul
Porto Alegre, Brazil, 90620-001
Hospital de Base - Fac Med de Sao Jose do Rio Preto
Sao Jose do Rio Preto, Brazil, 15090-000
Instituto Dante Pazzanese de Cardiologia
Sao Paulo, Brazil, 04012-909
Hospital Sao Paulo - UNIFESP
Sao Paulo, Brazil, 04024-002
INCOR e Hospital das Clínicas da Universidade de São Paulo
Sao Paulo, Brazil, 05403-000
Eurolatino pesquisas Médicas Ltda
Uberlandia, Brazil, 38411-186
Bulgaria
MHAT "Deva Maria", Dept. of Cardiology, Burgas
Burgas, Bulgaria, 8127
SHAT in Cardiology EAD, Pleven
Pleven, Bulgaria, 5800
MHAT"Sv.Georgi",Cardi.Clin.
Plovdiv, Bulgaria, 4001
MHAT "Sv. Vrach" EOOD, Cardiology Dept., Sandanski
Sandanski, Bulgaria, 2800
City Clin.Univ.MPHAT EOOD,Clin.of Cardiology, Sofia
Sofia, Bulgaria, 1407
Specialized Hosp.f.Active Treatment, Cardiology Dept, Yambol
Yambol, Bulgaria, 8600
Canada, Alberta
Calgary Heart Centre
Calgary, Alberta, Canada, T2N 4Z6
Canada, Manitoba
St. Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Kawartha Cardiology Clinical Trials
Peterborough, Ontario, Canada, K9J 0B2
Dr. R. Labonte Prof. Med. Corp
Sudbury, Ontario, Canada, P3E 3B8
Thunder Bay Regional Health Science Centre
Thunder Bay, Ontario, Canada, P7B 6V4
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1
CHUS Fleurimont
Sherbrooke, Quebec, Canada, J1H 5N4
IUCPQ (Laval University)
Ste-Foy, Quebec, Canada, GLV 4G5
Chile
Hospital San Juan de Dios
Santiago, Chile, 8350488
Centro de Estudios Clinicos Barros Luco
Santiago, Chile, 8910131
Hospital Las Higueras
Talcahuano, Chile, 4270918
CECMI Ltda
Temuco, Chile, 4813299
Colombia
Fundación Clínica Abood Shaio
Bogotá, Colombia
Fundación Santa Fe de Bogotá
Bogotá, Colombia
Centro Médico Imbanaco de Cali S.A.
Cali, Colombia, 760042
Fundación Valle de Lili
Cali, Colombia
Fundación Cardiovascular de Colombia
Floridablanca, Colombia, 680004
Hospital Pablo Tobón Uribe
Medellin, Colombia, 050034
Croatia
Clincal Hospital Centre Rijeka
Rijeka, Croatia, 51000
Clinical Hosp.Merkur,Clin.Internal Med,Cardiology Dep,Zagreb
Zagreb, Croatia, 10 000
Clinical Hospital Sstre Milosrdnice, Cardiology Dept, Zagreb
Zagreb, Croatia, 10000
University hospital center Zagreb
Zagreb, Croatia, 10000
University Hospital Dubrava
Zagreb, Croatia, 10000
Czechia
Amkardia, s.r.o. Brno
Brno, Czechia, 63900
Hospital Jihlava
Jihlava, Czechia, 586 33
Karlovarska Reg.Hosp, Cardiology Dept, Karlovy Vary
Karlovy Vary, Czechia, 36001
University Hospital Olomouc
Olomouc, Czechia, 775 20
Municipal Hospital Ostrava
Ostrava, Czechia, 728 80
Institute for Clinical and Experimental Medicine
Praha 4, Czechia, 140 21
General Faculty Hospital, Prague
Praha, Czechia, 128 08
University Hospital Motol
Praha, Czechia, 150 06
Hospital Slany, Internal Department
Slany, Czechia, 274 01
Hospitals of Pardubice Region, Internal Department, Svitavy
Svitavy, Czechia, 568 25
Masaryk Hospital, Usti nad Labem
Usti nad Labem, Czechia, 401 13
Hosp.of Pardubice Reg,Orlickoustecka,Internal Dept, Ustinad
Usti nad Orlici, Czechia, 562 18
Denmark
Aarhus Universitetshospital
Århus N, Denmark, 8200
Finland
HYKS, Kardiologian klinikka, Sydän- ja keuhkokeskus
Helsinki, Finland, 00290
StudyCor Oy
Jyväskylä, Finland, 42620
Keski-Pohjanmaan keskussairaala, Kardiologian pkl, Kokkola
Kokkola, Finland, 67200
TYKS
Turku, Finland, 20520
France
HOP Ambroise Paré
Boulogne-Billancourt, France, 92104
HOP de la Cavale Blanche
Brest Cedex 2, France, 29609
HOP Gabriel-Montpied
Clermont-Ferrand, France, 63003
HOP CHU de Grenoble
Grenoble, France, 38043
HOP St Joseph
Marseille, France, 13285
CLI du Pont de Chaume
Montauban, France, 82000
HOP Arnaud de Villeneuve
Montpellier cedex 5, France, 34295
HOP Pasteur
Nice, France, 06002
HOP Salpêtrière, Cardio, Paris
Paris cedex 13, France, 75651
HOP Lariboisière
Paris, France, 75010
CLI Saint-Hilaire
Rouen, France, 76000
HOP Rangueil
Toulouse, France, 31403
Germany
SLK-Kliniken Heilbronn GmbH
Bad Friedrichshall, Germany, 74177
Kerckhoff-Klinik, Bad Nauheim
Bad Nauheim, Germany, 61231
Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen
Bad Oeynhausen, Germany, 32545
CIMS Studienzentrum Bamberg GmbH
Bamberg, Germany, 96049
Vivantes Netzwerk für Gesundheit GmbH
Berlin, Germany, 10967
Charité - Universitätsmedizin Berlin
Berlin, Germany, 12200
Vivantes Netzwerk für Gesundheit GmbH
Berlin, Germany, 12351
Charité - Universitätsmedizin Berlin
Berlin, Germany, 13353
Klinikum Bielefeld gGmbH
Bielefeld, Germany, 33604
St. Josef- und St. Elisabeth-Hospital gGmbH
Bochum, Germany, 44791
Universitätsklinikum Bonn AöR
Bonn, Germany, 53127
Allgemeines Krankenhaus, Celle
Celle, Germany, 29223
Klinikum Coburg gGmbH
Coburg, Germany, 96450
Helios Amper-Klinikum Dachau
Dachau, Germany, 85221
St. Johannes Hospital Dortmund
Dortmund, Germany, 44137
Städtisches Klinikum Dresden
Dresden, Germany, 01067
Praxisklinik Herz und Gefäße
Dresden, Germany, 01324
Evangelisches Krankenhaus Düsseldorf
Düsseldorf, Germany, 40217
Agaplesion Markus Krankenhaus
Frankfurt, Germany, 60431
Universitätsklinikum Frankfurt
Frankfurt, Germany, 60590
Städtisches Klinikum, Fulda
Fulda, Germany, 36043
Herz- und Gefäßzentrum (HGZ-Göttingen) am Krankenhaus Neu Bethlehem
Göttingen, Germany, 37073
Universitätsmedizin Göttingen, Georg-August-Universität
Göttingen, Germany, 37075
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Cardiologicum Hamburg
Hamburg, Germany, 22041
HPK-Heidelberger Praxisklinik
Heidelberg, Germany, 69115
Westküstenkliniken Brunsbüttel und Heide gGmbH
Heide, Germany, 25746
Universitätsklinikum des Saarlandes
Homburg/Saar, Germany, 66421
Universitätsklinikum Jena
Jena, Germany, 07740
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, Germany, 24105
Asklepios Klinik Langen-Seligenstadt GmbH
Langen, Germany, 63225
Herzzentrum Leipzig GmbH
Leipzig, Germany, 04289
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Ludwigshafen, Germany, 67063
Märkische Gesundheitsholding GmbH & Co. KG, Klinikum Lüdenscheid
Lüdenscheid, Germany, 58515
Universitätsklinikum Magdeburg AöR
Magdeburg, Germany, 39120
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Germany, 55131
Universitätsklinikum Mannheim GmbH
Mannheim, Germany, 68167
Carl-von-Basedow Klinikum Saalekreis gGmgH
Merseburg, Germany, 06217
Klinikum der Universität München - Campus Großhadern
München, Germany, 81377
Städtisches Klinikum München GmbH
München, Germany, 81737
Städtisches Klinikum München GmbH
München, Germany, 81925
Universitätsklinikum Münster
Münster, Germany, 48149
St. Vincenz-Krankenhaus GmbH
Paderborn, Germany, 33098
Sana-Klinikum Remscheid GmbH
Remscheid, Germany, 42859
Universitätsmedizin Rostock
Rostock, Germany, 18057
Robert-Bosch-Krankenhaus GmbH
Stuttgart, Germany, 70376
Universitätsklinikum Tübingen
Tübingen, Germany, 72076
Universitätsklinikum Ulm
Ulm, Germany, 89081
Marien-Hospital-Wesel gGmbH
Wesel, Germany, 46483
Helios Universitätsklinikum Wuppertal
Wuppertal, Germany, 42117
Greece
University Hospital of Alexandroupolis
Alexandroupoli, Greece, 68100
Hippokration Hospital, Univ Clinic of Cardiology
Athens, Greece, 11527
General Hospital of Athens "Alexandra"
Athens, Greece, 11528
General Hospital of Athens Konstantopoulio-Agia Olga
Athens, Greece, 14233
General Hospital of Attica "Sismanoglio - Amalia Fleming"
Athens, Greece, 15126
General Hospital of Chios, Department of Cardiology
Chios, Greece, 82100
University General Hospital of Heraklion
Heraklion, Crete, Greece, 71110
Univ. Gen. Hosp. of Ioannina
Ioannina, Greece, 45500
University Hospital of Patras
Patras, Greece, 26504
University Hospital of Thessaloniki AHEPA
Thessaloniki, Greece, 54636
Hong Kong
Prince of Wales Hosp, Dept of Med & Therapeutics
Hong Kong, Hong Kong
Princess Margaret Hospital
Hong Kong, Hong Kong
Queen Elizabeth Hospital
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Hungary
Gottsegen Gyorgy Hungarian Instit.of Cardiology,Budapest
Budapest, Hungary, 1096
Semmelweis University
Budapest, Hungary, 1122
Milit.Hosp.-State Health Cent.
Budapest, Hungary, 1134
University Debrecen Hospital
Debrecen, Hungary, 4032
Bacs-Kiskun Megyei Onkormanyzat Hospital
Kecskemet, Hungary, 6000
University of Pecs, Invasive Cardiology
Pecs, Hungary, 7624
Univ. of Szeged, 2nd Dept. of Internal Med., Haematology
Szeged, Hungary, 6725
India
Care Institute Of Medical Sciences
Ahmedabad, India, 380060
Medanta- The Medicity
Gurgaon, India, 122001
Nizam's Institute of Medical Sciences
Hyderabad, India, 500034
B and M Patel Cardiac Centre, Shree Krishna Hospital,
Karamsad, India, 388325
Shri Krishna Hrudayalaya and Critical Care
Nagpur, India, 440012
Vijan Cardiac and Critical Care Centre
Nasik, India, 422005
Fortis Escorts Heart Institute
New Delhi, India, 110025
Byramjee Jeejeebhoy Medical College
Pune, India, 411001
King George's Hospital,
Seemandhra, India, 530002
Ireland
Mater Misericordiae University Hospital
Dublin, Ireland, DUBLIN 7
St James's Hospital
Dublin, Ireland, DUBLIN 8
Beaumont Hospital
Dublin, Ireland, DUBLIN 9
University Hospital Galway
Galway, Ireland, GALWAY
Israel
Hillel Yaffe Medical Center, Hadera
Hadera, Israel, 38100
Rambam Medical Center
Haifa, Israel, 31096
Wolfson Medical Center
Holon, Israel, 58100
Shaare Zedek Medical Center, Jerusalem 91031
Jerusalem, Israel, 91031
West.Galilee Med.Cent.Naharia
Naharia, Israel, 22100
Rabin Medical Center Beilinson
Petah Tikva, Israel, 49100
Italy
Ospedale San Donato di Arezzo
Arezzo, Italy, 52100
ASST Papa Giovanni XXIII - A.O. Papa Giovanni XXIII
Bergamo, Italy, 24127
Fond. Poliambulanza Istituto
Brescia, Italy, 25100
A.O.U. Policlinico Vittorio Emanuele
Catania, Italy, 95124
Osp. Clin. SS. Anunziata
Chieti, Italy, 66100
Ospedale "Fabrizio Spaziani"
Frosinone, Italy, 03100
Ospedale della Misericordia
Grosseto, Italy, 58100
Azienda Ospedaliera Vito Fazzi
Lecce, Italy, 73100
Osp. Pediatrico Aprano Pasquinucci
Massa, Italy, 54100
Ospedale Cardarelli
Napoli, Italy, 80131
Pol. Universitario Tor Vergata
Roma, Italy, 00133
Policlinico Gemelli
Roma, Italy, 00195
Presidio Ospedaliero di Saronno
Saronno (VA), Italy, 21047
Ospedale Bolognini
Seriate, Italy, 24068
Ospedale Molinette, AO Città della Salute e della
Torino, Italy, 10126
Japan
Japanese Red Cross Nagoya Daini Hospital
Aichi, Nagoya, Japan, 466-8650
Hirosaki University Hospital
Aomori, Hirosaki, Japan, 036-8563
Chiba University Hospital
Chiba, Chiba, Japan, 260-8677
Kokura Memorial Hospital
Fukuoka, Kitakyushu, Japan, 802-8555
Fukuoka-Higashi Med. Ctr. Fukuoka, CV
Fukuoka, Koga, Japan, 811-3195
Shin Koga Hospital
Fukuoka, Kurume, Japan, 830-8577
Gumma Prefectural Cardiovascular Center
Gunma, Maebashi, Japan, 371-0004
National Hospital Organization Takasaki General Medical Center
Gunma, Takasaki, Japan, 370-0829
Fukuyama Cardiovascular Hospital
Hiroshima, Fukuyama, Japan, 720-0804
Tokeidai Memorial Hospital
Hokkaido, Sapporo, Japan, 060-0031
National Hospital Organization Hokkaido Medical Center
Hokkaido, Sapporo, Japan, 063-0005
Hyogo Brain and Heart Center
Hyogo, Himeji, Japan, 670-0981
The Veritas Hospital
Hyogo, Kawanishi, Japan, 666-0125
Kobe University Hospital
Hyogo, Kobe, Japan, 650-0017
Takahashi Hospital
Hyogo, Kobe, Japan, 654-0026
National Hospital Organization Kanazawa Medical Center
Ishikawa, Kanazawa, Japan, 920-8650
Iwate Medical University Hospital
Iwate, Morioka, Japan, 020-8505
Kagawa Prefectural Central Hospital
Kagawa, Takamatsu, Japan, 760-8557
Shonan Fujisawa Tokushukai Hospital
Kanagawa, Fujisawa, Japan, 251-0041
Kitasato University Hospital
Kanagawa, Sagamihara, Japan, 252-0375
Yokohama City Minato Red Cross Hospital
Kanagawa, Yokohama, Japan, 231-8682
Kyoto University Hospital
Kyoto, Kyoto, Japan, 606-8507
Miyazaki Medical Association Hospital
Miyazaki, Miyazaki, Japan, 880-0834
Sakurabashi Watanabe Hospital
Osaka, Osaka, Japan, 530-0001
Osaka City Hospital Organization Osaka City General Hospital
Osaka, Osaka, Japan, 534-0021
Sayama General Clinic
Saitama, Sayama, Japan, 350-1305
National Hospital Organization Saitama National Hospital
Saitama, Wako, Japan, 351-0102
Kusatsu General Hospital
Shiga, Kusatsu, Japan, 525-8585
Omihachiman Community Medical Center
Shiga, Omihachiman, Japan, 523-0082
Tokushima Red Cross Hospital
Tokushima, Komatsushima, Japan, 773-8502
Nishiarai Heart Center Hospital
Tokyo, Adachi-ku, Japan, 123-0845
Nippon Medical School Hospital
Tokyo, Bunkyo-ku, Japan, 113-8603
Minamino Heart Clinic
Tokyo, Hachioji, Japan, 192-0918
Teikyo University Hospital
Tokyo, Itabashi-Ku, Japan, 173-8606
Nihon University Itabashi Hospital
Tokyo, Itabashi-Ku, Japan, 173-8610
Itabashi Chuo Medical Center
Tokyo, Itabashi-Ku, Japan, 174-0051
Global Health and Medicine Ctr
Tokyo, Shinjuku-ku, Japan, 162-8655
Tokyo Women's Medical University Hospital
Tokyo, Shinjuku-ku, Japan, 162-8666
Korea, Republic of
Inje University Haeundae Paik Hospital
Busan, Korea, Republic of, 612-896
Kyungpook National Univ. Hosp
Daegu, Korea, Republic of, 700-721
Yeungnam University Medical Center
Daegu, Korea, Republic of, 705-703
Chonnam National University Hospital
Gwangju, Korea, Republic of, 501-757
Pusan National Univ. Hosp
Pusan, Korea, Republic of, 602-739
Kyung Hee University Hospital
Seoul, Korea, Republic of, 02447
The Catholic University of Korea, Seoul St.Mary's Hospital
Seoul, Korea, Republic of, 06591
Korea University Guro Hospital
Seoul, Korea, Republic of, 08308
Severance Hospital
Seoul, Korea, Republic of, 120-752
Korea University Anam Hospital
Seoul, Korea, Republic of, 136-705
St.Carollo Hospital
Suncheon, Korea, Republic of, 540-719
Ajou University Hospital
Suwon, Korea, Republic of, 16499
Wonju Severance Christian Hosp
Wonju, Korea, Republic of, 220-701
Mexico
Hospital Cardiologica Aguascalientes
Aguascalientes, Mexico, 20230
Instituto Nacional de Cardiologia Ignacio Chavez
Ciudad de Mexico, Mexico, 14080
H. Central Dr Ignacio M. P.
San Luis Potosi, Mexico, 78240
Centro Especializado en Terapia Endovascular (CETEN)
Zapopan, Jalisco, Mexico, 45040
Netherlands
Noordwest Ziekenhuisgroep
Alkmaar, Netherlands, 1815 JD
Catharina Ziekenhuis
Eindhoven, Netherlands, 5623 EJ
Scheper Ziekenhuis
Emmen, Netherlands, 7824 AA
Admiraal de Ruyter Ziekenhuis
Goes, Netherlands, 4462 GA
UMCG
Groningen, Netherlands, 9713 GZ
St. Antonius ziekenhuis, locatie Nieuwegein
Nieuwegein, Netherlands, 3435 CM
Canisius-Wilhelmina ziekenhuis
Nijmegen, Netherlands, 6532 SZ
Ziekenhuis Bernhoven Uden
Uden, Netherlands, 5406 PT
New Zealand
Waikato Hospital
Hamilton, New Zealand, 3240
Norway
Sørlandet sykehus HF, Avd. Arendal
Arendal, Norway, N-4838
Oslo Universitetssykehus HF, Ullevål sykehus
Oslo, Norway, N-0407
Oslo Universitetssykehus HF, Rikshospitalet
Oslo, Norway, N-0424
Stavanger Helseforskning
Stavanger, Norway, N-4068
Universitetssykehuset Nord-Norge, Tromsø
Tromsø, Norway, N-9038
Poland
Univ. Clinic Hosp, Bialystok
Bialystok, Poland, 15276
10.Military Clin.Hospital&Polyclinic
Bydgoszcz, Poland, 85681
Swissmed Vascular Sp. Z.o.o Hosp., Cardiology Dept., Gdansk
Gdansk, Poland, 80215
University Clinical Center, Gdansk
Gdansk, Poland, 80952
Reg.Hosp Kielce,Swietokrzyskie,1.Clinic of Cardiology,Kielce
Kielce, Poland, 25736
Independent Public Clin.Hosp.#4, Cardiology Clinic,Lubilin
Lublin, Poland, 20954
Independent Public Healthcare, Dept. of Cardiology, Pulawy
Pulawy, Poland, 24100
Central Hospital of Medical Academy, Warsaw
Warsaw, Poland, 02-097
Lower Silesian Spec.Hosp.T.Marciniaka,Cardiology Dep,Wroclaw
Wroclaw, Poland, 54049
John Paul II Regional Hospital, Zamosc
Zamosc, Poland, 22400
Portugal
Hospital Garcia de Orta, EPE
Almada, Portugal, 2805-267
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
Coimbra, Portugal, 3000-075
Centro Hosp. de Leiria-Pombal
Leiria, Portugal, 2410-197
CHLC, EPE - Hospital de Santa Marta
Lisboa, Portugal, 1169-024
CHLO, EPE - Hospital de Santa Cruz
Lisboa, Portugal, 1495-005
CHLN, EPE - Hospital de Santa Maria
Lisboa, Portugal, 1649-035
CHUC,EPE - Hospital Geral dos Covões
S. Martinho Do Bispo,Coimbra, Portugal, 3041-801
Russian Federation
Altaiskyi Reg.Cardiologic Dispensary,Cardiology Dept,Barnaul
Barnaul, Russian Federation, 656055
Regional Clinical Hospital No.3, Cardiology Dept,Chelyabinsk
Chelyabinsk, Russian Federation, 454021
Cent.f.Spec.Med.C.U.Cardi.Inst
Ekaterinburg, Russian Federation, 620144
State Instit.Kazan Fed.Univ.
Kazan, Russian Federation, 420043
State Autonomous Healthc Insti City Clin Hosp#7,Cardio,Kazan
Kazan, Russian Federation, 420103
Res.Inst.-Compl.Iss.Cardi.Dis.
Kemerovo, Russian Federation, 650002
Clin.Hosp.#1na S.V.Ochapovskiy
Krasnodar, Russian Federation, 350086
City Clin.Hosp.#15 n.a.O.M.Filatov,Cardiology Dept.#2,Moscow
Moscow, Russian Federation, 111 539
City Clin.Hosp#51,Moscow Healthcare Dep.X-ray surgery method
Moscow, Russian Federation, 121309
Cntr of CV Surgery na Bakulev,Surg.Treatm of Inter.Path.dept
Moscow, Russian Federation, 121552
City Pokrovskiy Hospital, Cardiology Dept., Saint Petersburg
Saint Petersburg, Russian Federation, 199 106
State Budg.Healthc.Instit.Samara Reg.Clin.Cardiology Dispens
Samara, Russian Federation, 443070
North-Western Fed.Med.Resear.Centr na V.I.Almazov,Cardio.dep
St.Petersburg, Russian Federation, 197341
State Budg.Healthc.Instit Volgograd RegClin.Cardiology Centr
Volgograd, Russian Federation, 400008
Singapore
National University Hospital
Singapore, Singapore, 119228
National Heart Center
Singapore, Singapore, 169609
Slovakia
Slov.Ins.Crdi.Dise.,Cor.C.U.
Banska Bystrica, Slovakia, 97401
Nat.Instit.Cardiov.Diseas,Arryhythmias&Cardiac Pacing,Bratis
Bratislava, Slovakia, 83348
East Slovak Inst.Cardi.Disea.
Kosice, Slovakia, 04011
Kardiocentrum Nitra,Internal Medicine Dept, Nitra
Nitra, Slovakia, 94901
Slovenia
General Hospital Celje
Celje, Slovenia, 3000
General Hospital Izola, Cardiology Department
Izola, Slovenia, 6310
University Medical Center Ljubljana
Ljubljana, Slovenia, 1000
Univ. Medical Center Maribor
Maribor, Slovenia, 2000
Spain
Hospital del Mar
Barcelona, Spain, 08003
Hospital Vall d'Hebron
Barcelona, Spain, 08035
Hospital Clínic de Barcelona
Barcelona, Spain, 08036
Hospital de Bellvitge
L'Hospitalet Llobregat (bcn), Spain, 08907
Hospital Ramón y Cajal
Madrid, Spain, 28034
Hospital Clínico San Carlos
Madrid, Spain, 28040
Hospital La Paz
Madrid, Spain, 28046
Hospital Virgen de la Victoria
Malaga, Spain, 29010
Hospital de Manises
Manises, Spain, 46940
CS Parc Taulí
Sabadell (Barcelona), Spain, 08208
Hospital Clínico de Santiago
Santiago de Compostela, Spain, 15706
Hospital Virgen del Rocío
Sevilla, Spain, 41013
Hospital de Galdakao
Vizcaya, Spain, 48960
Hospital Miguel Servet
Zaragoza, Spain, 50009
Sweden
Länssjukhuset, Gävle
Gävle, Sweden, 801 87
Sahlgrenska Universitetssjukhuset, Östra
Göteborg, Sweden, 416 85
Länssjukhuset, Halmstad
Halmstad, Sweden, 301 85
Lasarettet, Helsingborg
Helsingborg, Sweden, 251 87
Universitetssjukhuset, Linköping
Linköping, Sweden, 581 85
Skånes universitetssjukhus, Lund
Lund, Sweden, 221 85
Skånes universitetssjukhus, Malmö
Malmö, Sweden, 205 02
Danderyds Sjukhus
Stockholm, Sweden, 182 88
Taiwan
Chang-Hua Christian Hospital
Changhua, Taiwan, 500
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan, 80756
E-Da Hospital
Kaohsiung, Taiwan, 824
China Medical University Hospital
Taichung, Taiwan, 40447
NCKUH
Tainan, Taiwan, 704
National Taiwan University Hospital
Taipei, Taiwan, 10002
Taipe Veterans General Hospital
Taipei, Taiwan, 11217
Chang Gung Memorial Hospital(TaoYuan)
Taoyuan, Taiwan, 330
Thailand
Siriraj Hospital
Bangkok, Thailand, 10170
Ramathibodi Hospital
Bangkok, Thailand, 10400
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, Thailand, 50200
Srinagarind Hospital
Khon Kaen, Thailand, 40002
Turkey
Cukurova Universitesi Tip Fakultesi Kardiyoloji AnabilimDali
Adana, Turkey, 01330
Türkiye Yüksek Ihtisas Egitim ve Arastirma Hastanesi
Ankara, Turkey, 06100
Diskapi Yildirim Beyazit EAH
Ankara, Turkey, 06110
Bursa Yuksek Ihtisas EAH
Bursa, Turkey, 16330
Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
Istanbul, Turkey, 34093
Istanbul Universitesi Kardiyoloji Enstitusu
Istanbul, Turkey, 34096
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul, Turkey, 34098
Bagcilar Egitim ve Arastirma Hastanesi
Istanbul, Turkey, 34200
Medipol Mega Üniversitesi Hastanesi
Istanbul, Turkey, 34214
Istanbul Mehmet Akif Ersoy Egitim ve Arastirma Hastanesi
Istanbul, Turkey, 34303
Siyami Ersek Gogus Kalp ve Damar Cerrahisi Hastanesi
Istanbul, Turkey, 34668
Kartal Kosuyolu Yuksek Ihtisas EAH
Istanbul, Turkey, 34846
Dokuz Eylul Unv. Tip Fakultesi
Izmir, Turkey, 35340
Izmir Katip Celebi Univ. EAH
Izmir, Turkey, 35360
Erciyes Universitesi Tip Fakultesi Kardiyoloji Anabilim Dali
Kayseri, Turkey, 38039
Ondokuz Mayis Universitesi Tip Fakultesi
Samsun, Turkey, 55139
United Kingdom
Birmingham City Hospital
Birmingham, United Kingdom, B18 7QH
Royal Bournemouth and Christchurch Hospital
Bournemouth, United Kingdom, BH7 7DW
Royal Derby Hospital
Derby, United Kingdom, DE22 3NE
Dorset County Hospital
Dorchester, United Kingdom, DT1 2JY
Grantham District Hospital
Grantham, United Kingdom, NG31 8DG
Wycombe General Hospital
High Wycombe, United Kingdom, HP11 2TT
Glenfield Hospital
Leicester, United Kingdom, LE3 9QP
Lincoln County Hospital
Lincoln, United Kingdom, LN2 5QY
Altnagelvin Area Hospital
Londonderry, United Kingdom, BT47 6SB
St Bartholomew's Hospital
London, United Kingdom, EC1A 7BE
James Cook University Hospital
Middlesbrough, United Kingdom, TS4 3BW
Royal Stoke University Hospital
Stoke-on-Trent, United Kingdom, ST4 6QG
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Layout table for investigator information
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  Study Documents (Full-Text)

Documents provided by Boehringer Ingelheim:
Study Protocol  [PDF] July 21, 2016
Statistical Analysis Plan  [PDF] June 9, 2017


Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02164864     History of Changes
Other Study ID Numbers: 1160.186
2013-003201-26 ( EudraCT Number )
First Posted: June 17, 2014    Key Record Dates
Results First Posted: July 31, 2018
Last Update Posted: July 31, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Aspirin
Warfarin
Dabigatran
Clopidogrel
Ticagrelor
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents