Clinical trial NCT02164864: Evaluation of Dual Therapy With Dabigatran vs. Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting (REDUAL-PCI)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Percutaneous Coronary Intervention
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-06-17
Enrollment: 2725
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Time to First Adjudicated ISTH MBE or CRNMBE
timeFrame: up to 30 months
Secondary outcomes:
measure: Time to Adjudicated Undetermined Cause of Death
timeFrame: up to 30 months
measure: Time to Adjudicated Non-CV
timeFrame: up to 30 months
measure: Time to Adjudicated CV
timeFrame: up to 30 months
measure: Time to Adjudicated All Cause Death
timeFrame: up to 30 months
measure: Time to First Adjudicated MI
timeFrame: up to 30 months
measure: Time to First Adjudicated Stroke
timeFrame: up to 30 months
measure: Time to First Adjudicated SE
timeFrame: up to 30 months
measure: Time to First Adjudicated ST
timeFrame: up to 30 months
measure: Time to Composite Endpoint of Death + MI + Stroke
timeFrame: up to 30 months
measure: Time to Composite Endpoint of Death or First Thrombotic Event
timeFrame: up to 30 months
measure: Time to First Adjudicated Unplanned Revascularisation by PCI/CABG
timeFrame: up to 30 months
measure: Time to Death or First Thrombotic Event or Unplanned Revascularisation by PCI/CABG
timeFrame: up to 30 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cardiology P.C.
state: Alabama
city: Cottonwood
country: United States
facility: Verde Valley Medical Center
state: Arizona
city: Mesa
country: United States
facility: Cardiovascular Associates of Mesa
state: Arizona
city: Scottsdale
country: United States
facility: HonorHealth Research Institute
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Cardiology, PA
state: Arkansas
city: Fremont
country: United States
facility: Mission Cardiovascular Research Institute
state: California
city: Aurora
country: United States
facility: Aurora Denver Cardiology Associates, PC
state: Colorado
city: Jacksonville
country: United States
facility: University of Florida College of Medicine
state: Florida
city: Lakeland
country: United States
facility: Watson Clinic, LLP
state: Florida
city: Anderson
country: United States
facility: Community Clinical Research Center
state: Indiana
city: Elkhart
country: United States
facility: Midwest Cardiovascular Research and Education Foundation
state: Indiana
city: Muncie
country: United States
facility: Ball Memorial Hospital
state: Indiana
city: Richmond
country: United States
facility: Richmond Cardiology Associates Research, LLC
state: Indiana
city: Houma
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Hyannis
country: United States
facility: Cape Cod Research Institute
state: Massachusetts
city: Midland
country: United States
facility: Mid Michigan Medical Center
state: Michigan
city: Saginaw
country: United States
facility: Covenant Medical Center, Inc.
state: Michigan
city: Duluth
country: United States
facility: Saint Mary's Medical Center dba Essentia Health Saint Mary's Medical Center
state: Minnesota
city: Saint Cloud
country: United States
facility: CentraCare Heart and Vascular Center
state: Minnesota
city: Kansas City
country: United States
facility: Kansas City Veterans Administration Medical Center
state: Missouri
city: Saint Louis
country: United States
facility: Saint Anthony's Medical Center
state: Missouri
city: Newark
country: United States
facility: St. Michaels Medical Center
state: New Jersey
city: Voorhees
country: United States
facility: Lourdes Cardiology Services
state: New Jersey
city: Buffalo
country: United States
facility: VA Western New York Healthcare System
state: New York
city: Charlotte
country: United States
facility: Novant Health Heart and Vascular Institute
state: North Carolina
city: Grand Forks
country: United States
facility: Altru Health System
state: North Dakota
city: Toledo
country: United States
facility: Cardiovascular Research Center
state: Ohio
city: Chambersburg
country: United States
facility: Chambersburg Hospital
state: Pennsylvania
city: Harrisburg
country: United States
facility: Pinnacle Health Harrisburg Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Chattanooga
country: United States
facility: Chattanooga Heart Institute
state: Tennessee
city: Jackson
country: United States
facility: The Jackson Clinic, PA
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
city: McKinney
country: United States
facility: North Dallas Research Associates
state: Texas
city: Round Rock
country: United States
facility: Scott and White Healthcare
state: Texas
city: San Antonio
country: United States
facility: South Texas Cardiovascular Consultants
state: Texas
city: Wichita Falls
country: United States
facility: Wichita Falls Heart Clinic
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Health Sciences Center
state: Utah
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Virginia Beach
country: United States
facility: Bayview Physicians Services PC dba Cardiovascular Associates
state: Virginia
city: Manitowoc
country: United States
facility: Holy Family Memorial, Inc
state: Wisconsin
city: Caba
country: Argentina
facility: Fundación Favaloro
city: Caba
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Caba
country: Argentina
facility: Instituto Cardiovascular de Buenos Aires
city: Capital Federal
country: Argentina
facility: Consultorios Asociados de Endocrinología e Invest Clínica
city: Corrientes
country: Argentina
facility: Instituto de Cardiología de Corrientes
city: Córdoba
country: Argentina
facility: Sanatorio Allende
city: Quilmes
country: Argentina
facility: Instituto CER
city: San Luis
country: Argentina
facility: Inst.Cardiovascular San Luis
city: San Miguel de Tucumán
country: Argentina
facility: Investigaciones Clinicas Tucumán
city: Adamstown
country: Australia
facility: Pendlebury Research
state: New South Wales
city: Gosford
country: Australia
facility: Gosford Hospital
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Wollongong
country: Australia
facility: Wollongong Hospital
state: New South Wales
city: Chermside
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Bundoora
country: Australia
facility: Heartcare Victoria
state: Victoria
city: Geelong
country: Australia
facility: The Geelong Hospital
state: Victoria
city: Linz
country: Austria
facility: Order Hospital Elisabethinen Linz
city: Salzburg
country: Austria
facility: LKH Salzburg, Univ. Clinic
city: Wien
country: Austria
facility: Wilhelminenspital
city: Aalst
country: Belgium
facility: Aalst - HOSP Onze-Lieve-Vrouw
city: Bonheiden
country: Belgium
facility: Bonheiden - HOSP Imelda
city: Brussel
country: Belgium
facility: Brussels-UNIV Brugmann -Horta
city: Brussel
country: Belgium
facility: Brussels - UNIV UZ Brussel
city: Gent
country: Belgium
facility: AZ Sint-Lucas - Campus Sint Lucas
city: Gilly
country: Belgium
facility: Charleroi - HOSP St-Joseph
city: Middelheim
country: Belgium
facility: Ziekenhuis Netwerk Antwerpen (ZNA) - Campus Middelheim
city: Sint-Niklaas
country: Belgium
facility: Sint-Niklaas - HOSP AZ Nikolaas (Campus St-Niklaas)
city: Tienen
country: Belgium
facility: Tienen - PRAC De Wolf, Axel
city: Ukkel
country: Belgium
facility: Brussels - HOSP Europe (Ste-Elisabeth)
city: Blumenau
country: Brazil
facility: Hospital Santa Isabel
city: Campina Grande do Sul
country: Brazil
facility: Irmandade da Santa Casa de Misericordia de Curitiba
city: Porto Alegre
country: Brazil
facility: Instituto de Cardiologia Rio Grande do Sul
city: Sao Jose do Rio Preto
country: Brazil
facility: Hospital de Base - Fac Med de Sao Jose do Rio Preto
city: Sao Paulo
country: Brazil
facility: Instituto Dante Pazzanese de Cardiologia
city: Sao Paulo
country: Brazil
facility: Hospital Sao Paulo - UNIFESP
city: Sao Paulo
country: Brazil
facility: INCOR e Hospital das Clínicas da Universidade de São Paulo
city: Uberlandia
country: Brazil
facility: Eurolatino pesquisas Médicas Ltda
city: Burgas
country: Bulgaria
facility: MHAT "Deva Maria", Dept. of Cardiology, Burgas
city: Pleven
country: Bulgaria
facility: SHAT in Cardiology EAD, Pleven
city: Plovdiv
country: Bulgaria
facility: MHAT"Sv.Georgi",Cardi.Clin.
city: Sandanski
country: Bulgaria
facility: MHAT "Sv. Vrach" EOOD, Cardiology Dept., Sandanski
city: Sofia
country: Bulgaria
facility: City Clin.Univ.MPHAT EOOD,Clin.of Cardiology, Sofia
city: Yambol
country: Bulgaria
facility: Specialized Hosp.f.Active Treatment, Cardiology Dept, Yambol
city: Calgary
country: Canada
facility: Calgary Heart Centre
state: Alberta
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Peterborough
country: Canada
facility: Kawartha Cardiology Clinical Trials
state: Ontario
city: Sudbury
country: Canada
facility: Dr. R. Labonte Prof. Med. Corp
state: Ontario
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Health Science Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
city: Sherbrooke
country: Canada
facility: CHUS Fleurimont
state: Quebec
city: Ste-Foy
country: Canada
facility: IUCPQ (Laval University)
state: Quebec
city: Santiago
country: Chile
facility: Hospital San Juan de Dios
city: Santiago
country: Chile
facility: Centro de Estudios Clinicos Barros Luco
city: Talcahuano
country: Chile
facility: Hospital Las Higueras
city: Temuco
country: Chile
facility: CECMI Ltda
city: Bogotá
country: Colombia
facility: Fundación Clínica Abood Shaio
city: Bogotá
country: Colombia
facility: Fundación Santa Fe de Bogotá
city: Cali
country: Colombia
facility: Centro Médico Imbanaco de Cali S.A.
city: Cali
country: Colombia
facility: Fundación Valle de Lili
city: Floridablanca
country: Colombia
facility: Fundación Cardiovascular de Colombia
city: Medellin
country: Colombia
facility: Hospital Pablo Tobón Uribe
city: Rijeka
country: Croatia
facility: Clincal Hospital Centre Rijeka
city: Zagreb
country: Croatia
facility: Clinical Hosp.Merkur,Clin.Internal Med,Cardiology Dep,Zagreb
city: Zagreb
country: Croatia
facility: Clinical Hospital Sstre Milosrdnice, Cardiology Dept, Zagreb
city: Zagreb
country: Croatia
facility: University hospital center Zagreb
city: Zagreb
country: Croatia
facility: University Hospital Dubrava
city: Brno
country: Czechia
facility: Amkardia, s.r.o. Brno
city: Jihlava
country: Czechia
facility: Hospital Jihlava
city: Karlovy Vary
country: Czechia
facility: Karlovarska Reg.Hosp, Cardiology Dept, Karlovy Vary
city: Olomouc
country: Czechia
facility: University Hospital Olomouc
city: Ostrava
country: Czechia
facility: Municipal Hospital Ostrava
city: Praha 4
country: Czechia
facility: Institute for Clinical and Experimental Medicine
city: Praha
country: Czechia
facility: General Faculty Hospital, Prague
city: Praha
country: Czechia
facility: University Hospital Motol
city: Slany
country: Czechia
facility: Hospital Slany, Internal Department
city: Svitavy
country: Czechia
facility: Hospitals of Pardubice Region, Internal Department, Svitavy
city: Usti nad Labem
country: Czechia
facility: Masaryk Hospital, Usti nad Labem
city: Usti nad Orlici
country: Czechia
facility: Hosp.of Pardubice Reg,Orlickoustecka,Internal Dept, Ustinad
city: Århus N
country: Denmark
facility: Aarhus Universitetshospital
city: Helsinki
country: Finland
facility: HYKS, Kardiologian klinikka, Sydän- ja keuhkokeskus
city: Jyväskylä
country: Finland
facility: StudyCor Oy
city: Kokkola
country: Finland
facility: Keski-Pohjanmaan keskussairaala, Kardiologian pkl, Kokkola
city: Turku
country: Finland
facility: TYKS
city: Boulogne-Billancourt
country: France
facility: HOP Ambroise Paré
city: Brest Cedex 2
country: France
facility: HOP de la Cavale Blanche
city: Clermont-Ferrand
country: France
facility: HOP Gabriel-Montpied
city: Grenoble
country: France
facility: HOP CHU de Grenoble
city: Marseille
country: France
facility: HOP St Joseph
city: Montauban
country: France
facility: CLI du Pont de Chaume
city: Montpellier cedex 5
country: France
facility: HOP Arnaud de Villeneuve
city: Nice
country: France
facility: HOP Pasteur
city: Paris cedex 13
country: France
facility: HOP Salpêtrière, Cardio, Paris
city: Paris
country: France
facility: HOP Lariboisière
city: Rouen
country: France
facility: CLI Saint-Hilaire
city: Toulouse
country: France
facility: HOP Rangueil
city: Bad Friedrichshall
country: Germany
facility: SLK-Kliniken Heilbronn GmbH
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik, Bad Nauheim
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen
city: Bamberg
country: Germany
facility: CIMS Studienzentrum Bamberg GmbH
city: Berlin
country: Germany
facility: Vivantes Netzwerk für Gesundheit GmbH
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Vivantes Netzwerk für Gesundheit GmbH
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Bielefeld
country: Germany
facility: Klinikum Bielefeld gGmbH
city: Bochum
country: Germany
facility: St. Josef- und St. Elisabeth-Hospital gGmbH
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn AöR
city: Celle
country: Germany
facility: Allgemeines Krankenhaus, Celle
city: Coburg
country: Germany
facility: Klinikum Coburg gGmbH
city: Dachau
country: Germany
facility: Helios Amper-Klinikum Dachau
city: Dortmund
country: Germany
facility: St. Johannes Hospital Dortmund
city: Dresden
country: Germany
facility: Städtisches Klinikum Dresden
city: Dresden
country: Germany
facility: Praxisklinik Herz und Gefäße
city: Düsseldorf
country: Germany
facility: Evangelisches Krankenhaus Düsseldorf
city: Frankfurt
country: Germany
facility: Agaplesion Markus Krankenhaus
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
city: Fulda
country: Germany
facility: Städtisches Klinikum, Fulda
city: Göttingen
country: Germany
facility: Herz- und Gefäßzentrum (HGZ-Göttingen) am Krankenhaus Neu Bethlehem
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen, Georg-August-Universität
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Hamburg
country: Germany
facility: Cardiologicum Hamburg
city: Heidelberg
country: Germany
facility: HPK-Heidelberger Praxisklinik
city: Heide
country: Germany
facility: Westküstenkliniken Brunsbüttel und Heide gGmbH
city: Homburg/Saar
country: Germany
facility: Universitätsklinikum des Saarlandes
city: Jena
country: Germany
facility: Universitätsklinikum Jena
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel
city: Langen
country: Germany
facility: Asklepios Klinik Langen-Seligenstadt GmbH
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
city: Ludwigshafen
country: Germany
facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH
city: Lüdenscheid
country: Germany
facility: Märkische Gesundheitsholding GmbH & Co. KG, Klinikum Lüdenscheid
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg AöR
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz
city: Mannheim
country: Germany
facility: Universitätsklinikum Mannheim GmbH
city: Merseburg
country: Germany
facility: Carl-von-Basedow Klinikum Saalekreis gGmgH
city: München
country: Germany
facility: Klinikum der Universität München - Campus Großhadern
city: München
country: Germany
facility: Städtisches Klinikum München GmbH
city: München
country: Germany
facility: Städtisches Klinikum München GmbH
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Paderborn
country: Germany
facility: St. Vincenz-Krankenhaus GmbH
city: Remscheid
country: Germany
facility: Sana-Klinikum Remscheid GmbH
city: Rostock
country: Germany
facility: Universitätsmedizin Rostock
city: Stuttgart
country: Germany
facility: Robert-Bosch-Krankenhaus GmbH
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Wesel
country: Germany
facility: Marien-Hospital-Wesel gGmbH
city: Wuppertal
country: Germany
facility: Helios Universitätsklinikum Wuppertal
city: Alexandroupoli
country: Greece
facility: University Hospital of Alexandroupolis
city: Athens
country: Greece
facility: Hippokration Hospital, Univ Clinic of Cardiology
city: Athens
country: Greece
facility: General Hospital of Athens "Alexandra"
city: Athens
country: Greece
facility: General Hospital of Athens Konstantopoulio-Agia Olga
city: Athens
country: Greece
facility: General Hospital of Attica "Sismanoglio - Amalia Fleming"
city: Chios
country: Greece
facility: General Hospital of Chios, Department of Cardiology
city: Heraklion, Crete
country: Greece
facility: University General Hospital of Heraklion
city: Ioannina
country: Greece
facility: Univ. Gen. Hosp. of Ioannina
city: Patras
country: Greece
facility: University Hospital of Patras
city: Thessaloniki
country: Greece
facility: University Hospital of Thessaloniki AHEPA
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hosp, Dept of Med & Therapeutics
city: Hong Kong
country: Hong Kong
facility: Princess Margaret Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Elizabeth Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Budapest
country: Hungary
facility: Gottsegen Gyorgy Hungarian Instit.of Cardiology,Budapest
city: Budapest
country: Hungary
facility: Semmelweis University
city: Budapest
country: Hungary
facility: Milit.Hosp.-State Health Cent.
city: Debrecen
country: Hungary
facility: University Debrecen Hospital
city: Kecskemet
country: Hungary
facility: Bacs-Kiskun Megyei Onkormanyzat Hospital
city: Pecs
country: Hungary
facility: University of Pecs, Invasive Cardiology
city: Szeged
country: Hungary
facility: Univ. of Szeged, 2nd Dept. of Internal Med., Haematology
city: Ahmedabad
country: India
facility: Care Institute Of Medical Sciences
city: Gurgaon
country: India
facility: Medanta- The Medicity
city: Hyderabad
country: India
facility: Nizam's Institute of Medical Sciences
city: Karamsad
country: India
facility: B and M Patel Cardiac Centre, Shree Krishna Hospital,
city: Nagpur
country: India
facility: Shri Krishna Hrudayalaya and Critical Care
city: Nasik
country: India
facility: Vijan Cardiac and Critical Care Centre
city: New Delhi
country: India
facility: Fortis Escorts Heart Institute
city: Pune
country: India
facility: Byramjee Jeejeebhoy Medical College
city: Seemandhra
country: India
facility: King George's Hospital,
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital
city: Dublin
country: Ireland
facility: St James's Hospital
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Galway
country: Ireland
facility: University Hospital Galway
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center, Hadera
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Holon
country: Israel
facility: Wolfson Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center, Jerusalem 91031
city: Naharia
country: Israel
facility: West.Galilee Med.Cent.Naharia
city: Petah Tikva
country: Israel
facility: Rabin Medical Center Beilinson
city: Arezzo
country: Italy
facility: Ospedale San Donato di Arezzo
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII - A.O. Papa Giovanni XXIII
city: Brescia
country: Italy
facility: Fond. Poliambulanza Istituto
city: Catania
country: Italy
facility: A.O.U. Policlinico Vittorio Emanuele
city: Chieti
country: Italy
facility: Osp. Clin. SS. Anunziata
city: Frosinone
country: Italy
facility: Ospedale "Fabrizio Spaziani"
city: Grosseto
country: Italy
facility: Ospedale della Misericordia
city: Lecce
country: Italy
facility: Azienda Ospedaliera Vito Fazzi
city: Massa
country: Italy
facility: Osp. Pediatrico Aprano Pasquinucci
city: Napoli
country: Italy
facility: Ospedale Cardarelli
city: Roma
country: Italy
facility: Pol. Universitario Tor Vergata
city: Roma
country: Italy
facility: Policlinico Gemelli
city: Saronno (VA)
country: Italy
facility: Presidio Ospedaliero di Saronno
city: Seriate
country: Italy
facility: Ospedale Bolognini
city: Torino
country: Italy
facility: Ospedale Molinette, AO Città della Salute e della
city: Aichi, Nagoya
country: Japan
facility: Japanese Red Cross Nagoya Daini Hospital
city: Aomori, Hirosaki
country: Japan
facility: Hirosaki University Hospital
city: Chiba, Chiba
country: Japan
facility: Chiba University Hospital
city: Fukuoka, Kitakyushu
country: Japan
facility: Kokura Memorial Hospital
city: Fukuoka, Koga
country: Japan
facility: Fukuoka-Higashi Med. Ctr. Fukuoka, CV
city: Fukuoka, Kurume
country: Japan
facility: Shin Koga Hospital
city: Gunma, Maebashi
country: Japan
facility: Gumma Prefectural Cardiovascular Center
city: Gunma, Takasaki
country: Japan
facility: National Hospital Organization Takasaki General Medical Center
city: Hiroshima, Fukuyama
country: Japan
facility: Fukuyama Cardiovascular Hospital
city: Hokkaido, Sapporo
country: Japan
facility: Tokeidai Memorial Hospital
city: Hokkaido, Sapporo
country: Japan
facility: National Hospital Organization Hokkaido Medical Center
city: Hyogo, Himeji
country: Japan
facility: Hyogo Brain and Heart Center
city: Hyogo, Kawanishi
country: Japan
facility: The Veritas Hospital
city: Hyogo, Kobe
country: Japan
facility: Kobe University Hospital
city: Hyogo, Kobe
country: Japan
facility: Takahashi Hospital
city: Ishikawa, Kanazawa
country: Japan
facility: National Hospital Organization Kanazawa Medical Center
city: Iwate, Morioka
country: Japan
facility: Iwate Medical University Hospital
city: Kagawa, Takamatsu
country: Japan
facility: Kagawa Prefectural Central Hospital
city: Kanagawa, Fujisawa
country: Japan
facility: Shonan Fujisawa Tokushukai Hospital
city: Kanagawa, Sagamihara
country: Japan
facility: Kitasato University Hospital
city: Kanagawa, Yokohama
country: Japan
facility: Yokohama City Minato Red Cross Hospital
city: Kyoto, Kyoto
country: Japan
facility: Kyoto University Hospital
city: Miyazaki, Miyazaki
country: Japan
facility: Miyazaki Medical Association Hospital
city: Osaka, Osaka
country: Japan
facility: Sakurabashi Watanabe Hospital
city: Osaka, Osaka
country: Japan
facility: Osaka City Hospital Organization Osaka City General Hospital
city: Saitama, Sayama
country: Japan
facility: Sayama General Clinic
city: Saitama, Wako
country: Japan
facility: National Hospital Organization Saitama National Hospital
city: Shiga, Kusatsu
country: Japan
facility: Kusatsu General Hospital
city: Shiga, Omihachiman
country: Japan
facility: Omihachiman Community Medical Center
city: Tokushima, Komatsushima
country: Japan
facility: Tokushima Red Cross Hospital
city: Tokyo, Adachi-ku
country: Japan
facility: Nishiarai Heart Center Hospital
city: Tokyo, Bunkyo-ku
country: Japan
facility: Nippon Medical School Hospital
city: Tokyo, Hachioji
country: Japan
facility: Minamino Heart Clinic
city: Tokyo, Itabashi-Ku
country: Japan
facility: Teikyo University Hospital
city: Tokyo, Itabashi-Ku
country: Japan
facility: Nihon University Itabashi Hospital
city: Tokyo, Itabashi-Ku
country: Japan
facility: Itabashi Chuo Medical Center
city: Tokyo, Shinjuku-ku
country: Japan
facility: Global Health and Medicine Ctr
city: Tokyo, Shinjuku-ku
country: Japan
facility: Tokyo Women's Medical University Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National Univ. Hosp
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National Univ. Hosp
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St.Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Suncheon
country: Korea, Republic of
facility: St.Carollo Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hosp
city: Aguascalientes
country: Mexico
facility: Hospital Cardiologica Aguascalientes
city: Ciudad de Mexico
country: Mexico
facility: Instituto Nacional de Cardiologia Ignacio Chavez
city: San Luis Potosi
country: Mexico
facility: H. Central Dr Ignacio M. P.
city: Zapopan, Jalisco
country: Mexico
facility: Centro Especializado en Terapia Endovascular (CETEN)
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuisgroep
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Emmen
country: Netherlands
facility: Scheper Ziekenhuis
city: Goes
country: Netherlands
facility: Admiraal de Ruyter Ziekenhuis
city: Groningen
country: Netherlands
facility: UMCG
city: Nieuwegein
country: Netherlands
facility: St. Antonius ziekenhuis, locatie Nieuwegein
city: Nijmegen
country: Netherlands
facility: Canisius-Wilhelmina ziekenhuis
city: Uden
country: Netherlands
facility: Ziekenhuis Bernhoven Uden
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Arendal
country: Norway
facility: Sørlandet sykehus HF, Avd. Arendal
city: Oslo
country: Norway
facility: Oslo Universitetssykehus HF, Ullevål sykehus
city: Oslo
country: Norway
facility: Oslo Universitetssykehus HF, Rikshospitalet
city: Stavanger
country: Norway
facility: Stavanger Helseforskning
city: Tromsø
country: Norway
facility: Universitetssykehuset Nord-Norge, Tromsø
city: Bialystok
country: Poland
facility: Univ. Clinic Hosp, Bialystok
city: Bydgoszcz
country: Poland
facility: 10.Military Clin.Hospital&Polyclinic
city: Gdansk
country: Poland
facility: Swissmed Vascular Sp. Z.o.o Hosp., Cardiology Dept., Gdansk
city: Gdansk
country: Poland
facility: University Clinical Center, Gdansk
city: Kielce
country: Poland
facility: Reg.Hosp Kielce,Swietokrzyskie,1.Clinic of Cardiology,Kielce
city: Lublin
country: Poland
facility: Independent Public Clin.Hosp.#4, Cardiology Clinic,Lubilin
city: Pulawy
country: Poland
facility: Independent Public Healthcare, Dept. of Cardiology, Pulawy
city: Warsaw
country: Poland
facility: Central Hospital of Medical Academy, Warsaw
city: Wroclaw
country: Poland
facility: Lower Silesian Spec.Hosp.T.Marciniaka,Cardiology Dep,Wroclaw
city: Zamosc
country: Poland
facility: John Paul II Regional Hospital, Zamosc
city: Almada
country: Portugal
facility: Hospital Garcia de Orta, EPE
city: Coimbra
country: Portugal
facility: CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
city: Leiria
country: Portugal
facility: Centro Hosp. de Leiria-Pombal
city: Lisboa
country: Portugal
facility: CHLC, EPE - Hospital de Santa Marta
city: Lisboa
country: Portugal
facility: CHLO, EPE - Hospital de Santa Cruz
city: Lisboa
country: Portugal
facility: CHLN, EPE - Hospital de Santa Maria
city: S. Martinho Do Bispo,Coimbra
country: Portugal
facility: CHUC,EPE - Hospital Geral dos Covões
city: Barnaul
country: Russian Federation
facility: Altaiskyi Reg.Cardiologic Dispensary,Cardiology Dept,Barnaul
city: Chelyabinsk
country: Russian Federation
facility: Regional Clinical Hospital No.3, Cardiology Dept,Chelyabinsk
city: Ekaterinburg
country: Russian Federation
facility: Cent.f.Spec.Med.C.U.Cardi.Inst
city: Kazan
country: Russian Federation
facility: State Instit.Kazan Fed.Univ.
city: Kazan
country: Russian Federation
facility: State Autonomous Healthc Insti City Clin Hosp#7,Cardio,Kazan
city: Kemerovo
country: Russian Federation
facility: Res.Inst.-Compl.Iss.Cardi.Dis.
city: Krasnodar
country: Russian Federation
facility: Clin.Hosp.#1na S.V.Ochapovskiy
city: Moscow
country: Russian Federation
facility: City Clin.Hosp.#15 n.a.O.M.Filatov,Cardiology Dept.#2,Moscow
city: Moscow
country: Russian Federation
facility: City Clin.Hosp#51,Moscow Healthcare Dep.X-ray surgery method
city: Moscow
country: Russian Federation
facility: Cntr of CV Surgery na Bakulev,Surg.Treatm of Inter.Path.dept
city: Saint Petersburg
country: Russian Federation
facility: City Pokrovskiy Hospital, Cardiology Dept., Saint Petersburg
city: Samara
country: Russian Federation
facility: State Budg.Healthc.Instit.Samara Reg.Clin.Cardiology Dispens
city: St.Petersburg
country: Russian Federation
facility: North-Western Fed.Med.Resear.Centr na V.I.Almazov,Cardio.dep
city: Volgograd
country: Russian Federation
facility: State Budg.Healthc.Instit Volgograd RegClin.Cardiology Centr
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: National Heart Center
city: Banska Bystrica
country: Slovakia
facility: Slov.Ins.Crdi.Dise.,Cor.C.U.
city: Bratislava
country: Slovakia
facility: Nat.Instit.Cardiov.Diseas,Arryhythmias&Cardiac Pacing,Bratis
city: Kosice
country: Slovakia
facility: East Slovak Inst.Cardi.Disea.
city: Nitra
country: Slovakia
facility: Kardiocentrum Nitra,Internal Medicine Dept, Nitra
city: Celje
country: Slovenia
facility: General Hospital Celje
city: Izola
country: Slovenia
facility: General Hospital Izola, Cardiology Department
city: Ljubljana
country: Slovenia
facility: University Medical Center Ljubljana
city: Maribor
country: Slovenia
facility: Univ. Medical Center Maribor
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: L'Hospitalet Llobregat (bcn)
country: Spain
facility: Hospital de Bellvitge
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital La Paz
city: Malaga
country: Spain
facility: Hospital Virgen de la Victoria
city: Manises
country: Spain
facility: Hospital de Manises
city: Sabadell (Barcelona)
country: Spain
facility: CS Parc Taulí
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico de Santiago
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocío
city: Vizcaya
country: Spain
facility: Hospital de Galdakao
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
city: Gävle
country: Sweden
facility: Länssjukhuset, Gävle
city: Göteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset, Östra
city: Halmstad
country: Sweden
facility: Länssjukhuset, Halmstad
city: Helsingborg
country: Sweden
facility: Lasarettet, Helsingborg
city: Linköping
country: Sweden
facility: Universitetssjukhuset, Linköping
city: Lund
country: Sweden
facility: Skånes universitetssjukhus, Lund
city: Malmö
country: Sweden
facility: Skånes universitetssjukhus, Malmö
city: Stockholm
country: Sweden
facility: Danderyds Sjukhus
city: Changhua
country: Taiwan
facility: Chang-Hua Christian Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: E-Da Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: NCKUH
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipe Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital(TaoYuan)
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital
city: Adana
country: Turkey
facility: Cukurova Universitesi Tip Fakultesi Kardiyoloji AnabilimDali
city: Ankara
country: Turkey
facility: Türkiye Yüksek Ihtisas Egitim ve Arastirma Hastanesi
city: Ankara
country: Turkey
facility: Diskapi Yildirim Beyazit EAH
city: Bursa
country: Turkey
facility: Bursa Yuksek Ihtisas EAH
city: Istanbul
country: Turkey
facility: Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Kardiyoloji Enstitusu
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi
city: Istanbul
country: Turkey
facility: Bagcilar Egitim ve Arastirma Hastanesi
city: Istanbul
country: Turkey
facility: Medipol Mega Üniversitesi Hastanesi
city: Istanbul
country: Turkey
facility: Istanbul Mehmet Akif Ersoy Egitim ve Arastirma Hastanesi
city: Istanbul
country: Turkey
facility: Siyami Ersek Gogus Kalp ve Damar Cerrahisi Hastanesi
city: Istanbul
country: Turkey
facility: Kartal Kosuyolu Yuksek Ihtisas EAH
city: Izmir
country: Turkey
facility: Dokuz Eylul Unv. Tip Fakultesi
city: Izmir
country: Turkey
facility: Izmir Katip Celebi Univ. EAH
city: Kayseri
country: Turkey
facility: Erciyes Universitesi Tip Fakultesi Kardiyoloji Anabilim Dali
city: Samsun
country: Turkey
facility: Ondokuz Mayis Universitesi Tip Fakultesi
city: Birmingham
country: United Kingdom
facility: Birmingham City Hospital
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth and Christchurch Hospital
city: Derby
country: United Kingdom
facility: Royal Derby Hospital
city: Dorchester
country: United Kingdom
facility: Dorset County Hospital
city: Grantham
country: United Kingdom
facility: Grantham District Hospital
city: High Wycombe
country: United Kingdom
facility: Wycombe General Hospital
city: Leicester
country: United Kingdom
facility: Glenfield Hospital
city: Lincoln
country: United Kingdom
facility: Lincoln County Hospital
city: Londonderry
country: United Kingdom
facility: Altnagelvin Area Hospital
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
city: Stoke-on-Trent
country: United Kingdom
facility: Royal Stoke University Hospital
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Nicolau JC, Bhatt DL, Hohnloser SH, Kimura T, Lip GYH, Miede C, Nordaby M, Oldgren J, Steg PG, Ten Berg JM, Godoy LC, Cannon CP; RE-DUAL PCI Steering Committee and Investigators. Dabigatran Dual Therapy vs Warfarin Triple Therapy Post-Percutaneous Coronary Intervention in Patients with Atrial Fibrillation With/Without a Proton Pump Inhibitor: A Pre-Specified Analysis of the RE-DUAL PCI Trial. Drugs. 2020 Jul;80(10):995-1005. doi: 10.1007/s40265-020-01323-x.
citation: De Caterina R, Procopio A, Lopez Sendon JL, Raev D, Mehta SR, Opolski G, Oldgren J, Steg PG, Hohnloser SH, Lip GYH, Kimura T, Kleine E, Ten Berg JM, Bhatt DL, Miede C, Nordaby M, Cannon CP; RE-DUAL PCI Steering Committee and Investigators. Comparison of Dabigatran Plus a P2Y12 Inhibitor With Warfarin-Based Triple Therapy Across Body Mass Index in RE-DUAL PCI. Am J Med. 2020 Nov;133(11):1302-1312. doi: 10.1016/j.amjmed.2020.03.045. Epub 2020 May 7.
citation: Berry NC, Mauri L, Steg PG, Bhatt DL, Hohnloser SH, Nordaby M, Miede C, Kimura T, Lip GYH, Oldgren J, Ten Berg JM, Cannon CP. Effect of Lesion Complexity and Clinical Risk Factors on the Efficacy and Safety of Dabigatran Dual Therapy Versus Warfarin Triple Therapy in Atrial Fibrillation After Percutaneous Coronary Intervention: A Subgroup Analysis From the REDUAL PCI Trial. Circ Cardiovasc Interv. 2020 Apr;13(4):e008349. doi: 10.1161/CIRCINTERVENTIONS.119.008349. Epub 2020 Apr 7.
citation: Hohnloser SH, Steg PG, Oldgren J, Nickenig G, Kiss RG, Ongen Z, Navarro Estrada JL, Oude Ophuis T, Lip GYH, Nordaby M, Kleine E, Ten Berg JM, Bhatt DL, Cannon CP; RE-DUAL PCI Steering Committee and Investigators. Renal Function and Outcomes With Dabigatran Dual Antithrombotic Therapy in Atrial Fibrillation Patients After PCI. JACC Cardiovasc Interv. 2019 Aug 26;12(16):1553-1561. doi: 10.1016/j.jcin.2019.05.050.
citation: Chi G, Kerneis M, Kalayci A, Liu Y, Mehran R, Bode C, Halperin JL, Verheugt FWA, Wildgoose P, van Eickels M, Lip GYH, Cohen M, Peterson ED, Fox KAA, Gibson CM. Safety and efficacy of non-vitamin K oral anticoagulant for atrial fibrillation patients after percutaneous coronary intervention: A bivariate analysis of the PIONEER AF-PCI and RE-DUAL PCI trial. Am Heart J. 2018 Sep;203:17-24. doi: 10.1016/j.ahj.2018.06.003. Epub 2018 Jun 13.
citation: Cannon CP, Bhatt DL, Oldgren J, Lip GYH, Ellis SG, Kimura T, Maeng M, Merkely B, Zeymer U, Gropper S, Nordaby M, Kleine E, Harper R, Manassie J, Januzzi JL, Ten Berg JM, Steg PG, Hohnloser SH; RE-DUAL PCI Steering Committee and Investigators. Dual Antithrombotic Therapy with Dabigatran after PCI in Atrial Fibrillation. N Engl J Med. 2017 Oct 19;377(16):1513-1524. doi: 10.1056/NEJMoa1708454. Epub 2017 Aug 27.