Evaluation of Dual Therapy With Dabigatran vs. Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting (REDUAL-PCI)
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
2 other identifiers
interventional
2,725
39 countries
409
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 atrial-fibrillation
Started Jul 2014
409 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2014
CompletedFirst Posted
Study publicly available on registry
June 17, 2014
CompletedStudy Start
First participant enrolled
July 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 5, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 5, 2017
CompletedResults Posted
Study results publicly available
July 31, 2018
CompletedJuly 31, 2018
July 1, 2018
2.9 years
June 13, 2014
June 5, 2018
July 27, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Time to First Adjudicated ISTH MBE or CRNMBE
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'.
up to 30 months
Secondary Outcomes (12)
Time to Adjudicated Undetermined Cause of Death
up to 30 months
Time to Adjudicated Non-CV
up to 30 months
Time to Adjudicated CV
up to 30 months
Time to Adjudicated All Cause Death
up to 30 months
Time to First Adjudicated MI
up to 30 months
- +7 more secondary outcomes
Study Arms (3)
Dabigatran Etexilate 110mg
EXPERIMENTALPatient to receive Dabigatran Etexilate 110mg twice a day (BID)
Dabigatran Etexilate 150mg
EXPERIMENTALPatient to receive Dabigatran Etexilate 150mg twice a day (BID)
Warfarin
ACTIVE COMPARATORWarfarin doses to maintain INR
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (421)
Cardiology P.C.
Birmingham, Alabama, 35211, United States
Verde Valley Medical Center
Cottonwood, Arizona, 86326, United States
Cardiovascular Associates of Mesa
Mesa, Arizona, 85206, United States
HonorHealth Research Institute
Scottsdale, Arizona, 85258, United States
Arkansas Cardiology, PA
Little Rock, Arkansas, 72205, United States
Mission Cardiovascular Research Institute
Fremont, California, 94538, United States
Aurora Denver Cardiology Associates, PC
Aurora, Colorado, 80012, United States
University of Florida College of Medicine
Jacksonville, Florida, 32209, United States
Watson Clinic, LLP
Lakeland, Florida, 33805, United States
Community Clinical Research Center
Anderson, Indiana, 46011, United States
Midwest Cardiovascular Research and Education Foundation
Elkhart, Indiana, 46514, United States
Ball Memorial Hospital
Muncie, Indiana, 47303, United States
Richmond Cardiology Associates Research, LLC
Richmond, Indiana, 47374, United States
Cardiovascular Institute of the South
Houma, Louisiana, 70360, United States
Maine Medical Center
Portland, Maine, 04102, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Cape Cod Research Institute
Hyannis, Massachusetts, 02601, United States
Mid Michigan Medical Center
Midland, Michigan, 48670, United States
Covenant Medical Center, Inc.
Saginaw, Michigan, 48602, United States
Saint Mary's Medical Center dba Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, 55805, United States
CentraCare Heart and Vascular Center
Saint Cloud, Minnesota, 56303, United States
Kansas City Veterans Administration Medical Center
Kansas City, Missouri, 64128, United States
Saint Anthony's Medical Center
St Louis, Missouri, 63128, United States
St. Michaels Medical Center
Newark, New Jersey, 07102, United States
Lourdes Cardiology Services
Voorhees Township, New Jersey, 08043, United States
VA Western New York Healthcare System
Buffalo, New York, 14215, United States
Novant Health Heart and Vascular Institute
Charlotte, North Carolina, 28204, United States
Altru Health System
Grand Forks, North Dakota, 58201, United States
Cardiovascular Research Center
Toledo, Ohio, 43608, United States
Chambersburg Hospital
Chambersburg, Pennsylvania, 17201, United States
Pinnacle Health Harrisburg Hospital
Harrisburg, Pennsylvania, 17101, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Chattanooga Heart Institute
Chattanooga, Tennessee, 37404, United States
The Jackson Clinic, PA
Jackson, Tennessee, 38301, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-8802, United States
Dallas VA Medical Center
Dallas, Texas, 75216, United States
North Dallas Research Associates
McKinney, Texas, 75069, United States
Scott and White Healthcare
Round Rock, Texas, 78665, United States
South Texas Cardiovascular Consultants
San Antonio, Texas, 78201, United States
Wichita Falls Heart Clinic
Wichita Falls, Texas, 76301, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
Bayview Physicians Services PC dba Cardiovascular Associates
Virginia Beach, Virginia, 23454, United States
Holy Family Memorial, Inc
Manitowoc, Wisconsin, 54220, United States
Fundación Favaloro
CABA, C1093AAS, Argentina
Hospital Italiano de Buenos Aires
CABA, C1199ABB, Argentina
Instituto Cardiovascular de Buenos Aires
CABA, C1428DCO, Argentina
Consultorios Asociados de Endocrinología e Invest Clínica
Capital Federal, C1425AGC, Argentina
Instituto de Cardiología de Corrientes
Corrientes, W3400AMZ, Argentina
Sanatorio Allende
Córdoba, X5000BFB, Argentina
Instituto CER
Quilmes, B1878DVB, Argentina
Inst.Cardiovascular San Luis
San Luis, D5702JRS, Argentina
Investigaciones Clinicas Tucumán
San Miguel de Tucumán, T4000ICL, Argentina
Pendlebury Research
Adamstown, New South Wales, 2289, Australia
Gosford Hospital
Gosford, New South Wales, 2250, Australia
Royal North Shore Hospital
St Leonards, New South Wales, 2065, Australia
Wollongong Hospital
Wollongong, New South Wales, 2500, Australia
The Prince Charles Hospital
Chermside, Queensland, 4032, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Heartcare Victoria
Bundoora, Victoria, 3083, Australia
The Geelong Hospital
Geelong, Victoria, 3220, Australia
Order Hospital Elisabethinen Linz
Linz, 4020, Austria
LKH Salzburg, Univ. Clinic
Salzburg, 5020, Austria
Wilhelminenspital
Vienna, 1160, Austria
Aalst - HOSP Onze-Lieve-Vrouw
Aalst, 9300, Belgium
Bonheiden - HOSP Imelda
Bonheiden, 2820, Belgium
Brussels-UNIV Brugmann -Horta
Brussels, 1020, Belgium
Brussels - UNIV UZ Brussel
Brussels, 1090, Belgium
AZ Sint-Lucas - Campus Sint Lucas
Ghent, 9000, Belgium
Charleroi - HOSP St-Joseph
Gilly, 6060, Belgium
Ziekenhuis Netwerk Antwerpen (ZNA) - Campus Middelheim
Middelheim, 2020, Belgium
Sint-Niklaas - HOSP AZ Nikolaas (Campus St-Niklaas)
Sint-Niklaas, 9100, Belgium
Tienen - PRAC De Wolf, Axel
Tienen, 3300, Belgium
Brussels - HOSP Europe (Ste-Elisabeth)
Uccle, 1180, Belgium
Hospital Santa Isabel
Blumenau, 89010-500, Brazil
Irmandade da Santa Casa de Misericordia de Curitiba
Campina Grande do Sul, 83430-000, Brazil
Instituto de Cardiologia Rio Grande do Sul
Porto Alegre, 90620-001, Brazil
Hospital de Base - Fac Med de Sao Jose do Rio Preto
São José do Rio Preto, 15090-000, Brazil
Instituto Dante Pazzanese de Cardiologia
São Paulo, 04012-909, Brazil
Hospital Sao Paulo - UNIFESP
São Paulo, 04024-002, Brazil
INCOR e Hospital das Clínicas da Universidade de São Paulo
São Paulo, 05403-000, Brazil
Eurolatino pesquisas Médicas Ltda
Uberlândia, 38411-186, Brazil
MHAT "Deva Maria", Dept. of Cardiology, Burgas
Burgas, 8127, Bulgaria
SHAT in Cardiology EAD, Pleven
Pleven, 5800, Bulgaria
MHAT"Sv.Georgi",Cardi.Clin.
Plovdiv, 4001, Bulgaria
MHAT "Sv. Vrach" EOOD, Cardiology Dept., Sandanski
Sandanski, 2800, Bulgaria
City Clin.Univ.MPHAT EOOD,Clin.of Cardiology, Sofia
Sofia, 1407, Bulgaria
Specialized Hosp.f.Active Treatment, Cardiology Dept, Yambol
Yambol, 8600, Bulgaria
Calgary Heart Centre
Calgary, Alberta, T2N 4Z6, Canada
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6, Canada
Dr. R. Labonte Prof. Med. Corp
Greater Sudbury, Ontario, P3E 3B8, Canada
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2, Canada
Kawartha Cardiology Clinical Trials
Peterborough, Ontario, K9J 0B2, Canada
Thunder Bay Regional Health Science Centre
Thunder Bay, Ontario, P7B 6V4, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1, Canada
CHUS Fleurimont
Sherbrooke, Quebec, J1H 5N4, Canada
IUCPQ (Laval University)
Ste-Foy, Quebec, GLV 4G5, Canada
Hospital San Juan de Dios
Santiago, 8350488, Chile
Centro de Estudios Clinicos Barros Luco
Santiago, 8910131, Chile
Hospital Las Higueras
Talcahuano, 4270918, Chile
CECMI Ltda
Temuco, 4813299, Chile
Fundación Clínica Abood Shaio
Bogotá, Colombia
Fundación Santa Fe de Bogotá
Bogotá, Colombia
Centro Médico Imbanaco de Cali S.A.
Cali, 760042, Colombia
Fundación Valle de Lili
Cali, Colombia
Fundación Cardiovascular de Colombia
Floridablanca, 680004, Colombia
Hospital Pablo Tobón Uribe
Medellín, 050034, Colombia
Clincal Hospital Centre Rijeka
Rijeka, 51000, Croatia
Clinical Hosp.Merkur,Clin.Internal Med,Cardiology Dep,Zagreb
Zagreb, 10 000, Croatia
Clinical Hospital Sstre Milosrdnice, Cardiology Dept, Zagreb
Zagreb, 10000, Croatia
University hospital center Zagreb
Zagreb, 10000, Croatia
University Hospital Dubrava
Zagreb, 10000, Croatia
Amkardia, s.r.o. Brno
Brno, 63900, Czechia
Hospital Jihlava
Jihlava, 586 33, Czechia
Karlovarska Reg.Hosp, Cardiology Dept, Karlovy Vary
Karlovy Vary, 36001, Czechia
University Hospital Olomouc
Olomouc, 775 20, Czechia
Municipal Hospital Ostrava
Ostrava, 728 80, Czechia
General Faculty Hospital, Prague
Prague, 128 08, Czechia
Institute for Clinical and Experimental Medicine
Prague, 140 21, Czechia
University Hospital Motol
Prague, 150 06, Czechia
Hospital Slany, Internal Department
Slaný, 274 01, Czechia
Hospitals of Pardubice Region, Internal Department, Svitavy
Svitavy, 568 25, Czechia
Masaryk Hospital, Usti nad Labem
Ústí nad Labem, 401 13, Czechia
Hosp.of Pardubice Reg,Orlickoustecka,Internal Dept, Ustinad
Ústí nad Orlicí, 562 18, Czechia
Aarhus Universitetshospital
Århus N, 8200, Denmark
HYKS, Kardiologian klinikka, Sydän- ja keuhkokeskus
Helsinki, 00290, Finland
StudyCor Oy
Jyväskylä, 42620, Finland
Keski-Pohjanmaan keskussairaala, Kardiologian pkl, Kokkola
Kokkola, 67200, Finland
TYKS
Turku, 20520, Finland
HOP Ambroise Paré
Boulogne-Billancourt, 92104, France
HOP de la Cavale Blanche
Brest, 29609, France
HOP Gabriel-Montpied
Clermont-Ferrand, 63003, France
HOP CHU de Grenoble
Grenoble, 38043, France
HOP St Joseph
Marseille, 13285, France
CLI du Pont de Chaume
Montauban, 82000, France
HOP Arnaud de Villeneuve
Montpellier, 34295, France
HOP Pasteur
Nice, 06002, France
HOP Lariboisière
Paris, 75010, France
HOP Salpêtrière, Cardio, Paris
Paris, 75651, France
CLI Saint-Hilaire
Rouen, 76000, France
HOP Rangueil
Toulouse, 31403, France
SLK-Kliniken Heilbronn GmbH
Bad Friedrichshall, 74177, Germany
Kerckhoff-Klinik, Bad Nauheim
Bad Nauheim, 61231, Germany
Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen
Bad Oeynhausen, 32545, Germany
CIMS Studienzentrum Bamberg GmbH
Bamberg, 96049, Germany
Vivantes Netzwerk für Gesundheit GmbH
Berlin, 10967, Germany
Charité - Universitätsmedizin Berlin
Berlin, 12200, Germany
Vivantes Netzwerk für Gesundheit GmbH
Berlin, 12351, Germany
Charité - Universitätsmedizin Berlin
Berlin, 13353, Germany
Klinikum Bielefeld gGmbH
Bielefeld, 33604, Germany
St. Josef- und St. Elisabeth-Hospital gGmbH
Bochum, 44791, Germany
Universitätsklinikum Bonn AöR
Bonn, 53127, Germany
Allgemeines Krankenhaus, Celle
Celle, 29223, Germany
Klinikum Coburg gGmbH
Coburg, 96450, Germany
Helios Amper-Klinikum Dachau
Dachau, 85221, Germany
St. Johannes Hospital Dortmund
Dortmund, 44137, Germany
Städtisches Klinikum Dresden
Dresden, 01067, Germany
Praxisklinik Herz und Gefäße
Dresden, 01324, Germany
Evangelisches Krankenhaus Düsseldorf
Düsseldorf, 40217, Germany
Agaplesion Markus Krankenhaus
Frankfurt, 60431, Germany
Universitätsklinikum Frankfurt
Frankfurt, 60590, Germany
Städtisches Klinikum, Fulda
Fulda, 36043, Germany
Herz- und Gefäßzentrum (HGZ-Göttingen) am Krankenhaus Neu Bethlehem
Göttingen, 37073, Germany
Universitätsmedizin Göttingen, Georg-August-Universität
Göttingen, 37075, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246, Germany
Cardiologicum Hamburg
Hamburg, 22041, Germany
Westküstenkliniken Brunsbüttel und Heide gGmbH
Heide, 25746, Germany
HPK-Heidelberger Praxisklinik
Heidelberg, 69115, Germany
Universitätsklinikum des Saarlandes
Homburg/Saar, 66421, Germany
Universitätsklinikum Jena
Jena, 07740, Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, 24105, Germany
Asklepios Klinik Langen-Seligenstadt GmbH
Langen, 63225, Germany
Herzzentrum Leipzig GmbH
Leipzig, 04289, Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Ludwigshafen, 67063, Germany
Märkische Gesundheitsholding GmbH & Co. KG, Klinikum Lüdenscheid
Lüdenscheid, 58515, Germany
Universitätsklinikum Magdeburg AöR
Magdeburg, 39120, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131, Germany
Universitätsklinikum Mannheim GmbH
Mannheim, 68167, Germany
Carl-von-Basedow Klinikum Saalekreis gGmgH
Merseburg, 06217, Germany
Klinikum der Universität München - Campus Großhadern
München, 81377, Germany
Städtisches Klinikum München GmbH
München, 81737, Germany
Städtisches Klinikum München GmbH
München, 81925, Germany
Universitätsklinikum Münster
Münster, 48149, Germany
St. Vincenz-Krankenhaus GmbH
Paderborn, 33098, Germany
Sana-Klinikum Remscheid GmbH
Remscheid, 42859, Germany
Universitätsmedizin Rostock
Rostock, 18057, Germany
Robert-Bosch-Krankenhaus GmbH
Stuttgart, 70376, Germany
Universitätsklinikum Tübingen
Tübingen, 72076, Germany
Universitätsklinikum Ulm
Ulm, 89081, Germany
Marien-Hospital-Wesel gGmbH
Wesel, 46483, Germany
Helios Universitätsklinikum Wuppertal
Wuppertal, 42117, Germany
University Hospital of Alexandroupolis
Alexandroupoli, 68100, Greece
Hippokration Hospital, Univ Clinic of Cardiology
Athens, 11527, Greece
General Hospital of Athens "Alexandra"
Athens, 11528, Greece
General Hospital of Athens Konstantopoulio-Agia Olga
Athens, 14233, Greece
General Hospital of Attica "Sismanoglio - Amalia Fleming"
Athens, 15126, Greece
General Hospital of Chios, Department of Cardiology
Chios, 82100, Greece
University General Hospital of Heraklion
Heraklion, Crete, 71110, Greece
Univ. Gen. Hosp. of Ioannina
Ioannina, 45500, Greece
University Hospital of Patras
Pátrai, 26504, Greece
University Hospital of Thessaloniki AHEPA
Thessaloniki, 54636, Greece
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
Gottsegen Gyorgy Hungarian Instit.of Cardiology,Budapest
Budapest, 1096, Hungary
Semmelweis University
Budapest, 1122, Hungary
Milit.Hosp.-State Health Cent.
Budapest, 1134, Hungary
University Debrecen Hospital
Debrecen, 4032, Hungary
Bacs-Kiskun Megyei Onkormanyzat Hospital
Kecskemét, 6000, Hungary
University of Pecs, Invasive Cardiology
Pécs, 7624, Hungary
Univ. of Szeged, 2nd Dept. of Internal Med., Haematology
Szeged, 6725, Hungary
Care Institute Of Medical Sciences
Ahmedabad, 380060, India
Medanta- The Medicity
Gūrgaon, 122001, India
Nizam's Institute of Medical Sciences
Hyderabad, 500034, India
B and M Patel Cardiac Centre, Shree Krishna Hospital,
Karamsad, 388325, India
Shri Krishna Hrudayalaya and Critical Care
Nagpur, 440012, India
Vijan Cardiac and Critical Care Centre
Nashik, 422005, India
Fortis Escorts Heart Institute
New Delhi, 110025, India
Byramjee Jeejeebhoy Medical College
Pune, 411001, India
King George's Hospital,
Seemandhra, 530002, India
Mater Misericordiae University Hospital
Dublin, DUBLIN 7, Ireland
St James's Hospital
Dublin, DUBLIN 8, Ireland
Beaumont Hospital
Dublin, DUBLIN 9, Ireland
University Hospital Galway
Galway, GALWAY, Ireland
Hillel Yaffe Medical Center, Hadera
Hadera, 38100, Israel
Rambam Medical Center
Haifa, 31096, Israel
Wolfson Medical Center
Holon, 58100, Israel
Shaare Zedek Medical Center, Jerusalem 91031
Jerusalem, 91031, Israel
West.Galilee Med.Cent.Naharia
Nahariya, 22100, Israel
Rabin Medical Center Beilinson
Petah Tikva, 49100, Israel
Ospedale San Donato di Arezzo
Arezzo, 52100, Italy
ASST Papa Giovanni XXIII - A.O. Papa Giovanni XXIII
Bergamo, 24127, Italy
Fond. Poliambulanza Istituto
Brescia, 25100, Italy
A.O.U. Policlinico Vittorio Emanuele
Catania, 95124, Italy
Osp. Clin. SS. Anunziata
Chieti, 66100, Italy
Ospedale "Fabrizio Spaziani"
Frosinone, 03100, Italy
Ospedale della Misericordia
Grosseto, 58100, Italy
Azienda Ospedaliera Vito Fazzi
Lecce, 73100, Italy
Osp. Pediatrico Aprano Pasquinucci
Massa, 54100, Italy
Ospedale Cardarelli
Napoli, 80131, Italy
Pol. Universitario Tor Vergata
Roma, 00133, Italy
Policlinico Gemelli
Roma, 00195, Italy
Presidio Ospedaliero di Saronno
Saronno (VA), 21047, Italy
Ospedale Bolognini
Seriate, 24068, Italy
Ospedale Molinette, AO Città della Salute e della
Torino, 10126, Italy
Japanese Red Cross Nagoya Daini Hospital
Aichi, Nagoya, 466-8650, Japan
Hirosaki University Hospital
Aomori, Hirosaki, 036-8563, Japan
Chiba University Hospital
Chiba, Chiba, 260-8677, Japan
Kokura Memorial Hospital
Fukuoka, Kitakyushu, 802-8555, Japan
Fukuoka-Higashi Med. Ctr. Fukuoka, CV
Fukuoka, Koga, 811-3195, Japan
Shin Koga Hospital
Fukuoka, Kurume, 830-8577, Japan
Gumma Prefectural Cardiovascular Center
Gunma, Maebashi, 371-0004, Japan
National Hospital Organization Takasaki General Medical Center
Gunma, Takasaki, 370-0829, Japan
Fukuyama Cardiovascular Hospital
Hiroshima, Fukuyama, 720-0804, Japan
Tokeidai Memorial Hospital
Hokkaido, Sapporo, 060-0031, Japan
National Hospital Organization Hokkaido Medical Center
Hokkaido, Sapporo, 063-0005, Japan
Hyogo Brain and Heart Center
Hyogo, Himeji, 670-0981, Japan
The Veritas Hospital
Hyogo, Kawanishi, 666-0125, Japan
Kobe University Hospital
Hyogo, Kobe, 650-0017, Japan
Takahashi Hospital
Hyogo, Kobe, 654-0026, Japan
National Hospital Organization Kanazawa Medical Center
Ishikawa, Kanazawa, 920-8650, Japan
Iwate Medical University Hospital
Iwate, Morioka, 020-8505, Japan
Kagawa Prefectural Central Hospital
Kagawa, Takamatsu, 760-8557, Japan
Shonan Fujisawa Tokushukai Hospital
Kanagawa, Fujisawa, 251-0041, Japan
Kitasato University Hospital
Kanagawa, Sagamihara, 252-0375, Japan
Yokohama City Minato Red Cross Hospital
Kanagawa, Yokohama, 231-8682, Japan
Kyoto University Hospital
Kyoto, Kyoto, 606-8507, Japan
Miyazaki Medical Association Hospital
Miyazaki, Miyazaki, 880-0834, Japan
Sakurabashi Watanabe Hospital
Osaka, Osaka, 530-0001, Japan
Osaka City Hospital Organization Osaka City General Hospital
Osaka, Osaka, 534-0021, Japan
Sayama General Clinic
Saitama, Sayama, 350-1305, Japan
National Hospital Organization Saitama National Hospital
Saitama, Wako, 351-0102, Japan
Kusatsu General Hospital
Shiga, Kusatsu, 525-8585, Japan
Omihachiman Community Medical Center
Shiga, Omihachiman, 523-0082, Japan
Tokushima Red Cross Hospital
Tokushima, Komatsushima, 773-8502, Japan
Nishiarai Heart Center Hospital
Tokyo, Adachi-ku, 123-0845, Japan
Nippon Medical School Hospital
Tokyo, Bunkyo-ku, 113-8603, Japan
Minamino Heart Clinic
Tokyo, Hachioji, 192-0918, Japan
Teikyo University Hospital
Tokyo, Itabashi-Ku, 173-8606, Japan
Nihon University Itabashi Hospital
Tokyo, Itabashi-Ku, 173-8610, Japan
Itabashi Chuo Medical Center
Tokyo, Itabashi-Ku, 174-0051, Japan
Global Health and Medicine Ctr
Tokyo, Shinjuku-ku, 162-8655, Japan
Tokyo Women's Medical University Hospital
Tokyo, Shinjuku-ku, 162-8666, Japan
Hospital Cardiologica Aguascalientes
Aguascalientes, 20230, Mexico
Instituto Nacional de Cardiologia Ignacio Chavez
Mexico City, 14080, Mexico
H. Central Dr Ignacio M. P.
San Luis Potosí City, 78240, Mexico
Centro Especializado en Terapia Endovascular (CETEN)
Zapopan, Jalisco, 45040, Mexico
Noordwest Ziekenhuisgroep
Alkmaar, 1815 JD, Netherlands
Catharina Ziekenhuis
Eindhoven, 5623 EJ, Netherlands
Scheper Ziekenhuis
Emmen, 7824 AA, Netherlands
Admiraal de Ruyter Ziekenhuis
Goes, 4462 GA, Netherlands
UMCG
Groningen, 9713 GZ, Netherlands
St. Antonius ziekenhuis, locatie Nieuwegein
Nieuwegein, 3435 CM, Netherlands
Canisius-Wilhelmina ziekenhuis
Nijmegen, 6532 SZ, Netherlands
Ziekenhuis Bernhoven Uden
Uden, 5406 PT, Netherlands
Waikato Hospital
Hamilton, 3240, New Zealand
Sørlandet sykehus HF, Avd. Arendal
Arendal, N-4838, Norway
Oslo Universitetssykehus HF, Ullevål sykehus
Oslo, N-0407, Norway
Oslo Universitetssykehus HF, Rikshospitalet
Oslo, N-0424, Norway
Stavanger Helseforskning
Stavanger, N-4068, Norway
Universitetssykehuset Nord-Norge, Tromsø
Tromsø, N-9038, Norway
Univ. Clinic Hosp, Bialystok
Bialystok, 15276, Poland
10.Military Clin.Hospital&Polyclinic
Bydgoszcz, 85681, Poland
Swissmed Vascular Sp. Z.o.o Hosp., Cardiology Dept., Gdansk
Gdansk, 80215, Poland
University Clinical Center, Gdansk
Gdansk, 80952, Poland
Reg.Hosp Kielce,Swietokrzyskie,1.Clinic of Cardiology,Kielce
Kielce, 25736, Poland
Independent Public Clin.Hosp.#4, Cardiology Clinic,Lubilin
Lublin, 20954, Poland
Independent Public Healthcare, Dept. of Cardiology, Pulawy
Puławy, 24100, Poland
Central Hospital of Medical Academy, Warsaw
Warsaw, 02-097, Poland
Lower Silesian Spec.Hosp.T.Marciniaka,Cardiology Dep,Wroclaw
Wroclaw, 54049, Poland
John Paul II Regional Hospital, Zamosc
Zamość, 22400, Poland
Hospital Garcia de Orta, EPE
Almada, 2805-267, Portugal
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
Coimbra, 3000-075, Portugal
Centro Hosp. de Leiria-Pombal
Leiria, 2410-197, Portugal
CHLC, EPE - Hospital de Santa Marta
Lisbon, 1169-024, Portugal
CHLO, EPE - Hospital de Santa Cruz
Lisbon, 1495-005, Portugal
CHLN, EPE - Hospital de Santa Maria
Lisbon, 1649-035, Portugal
CHUC,EPE - Hospital Geral dos Covões
S. Martinho Do Bispo,Coimbra, 3041-801, Portugal
Altaiskyi Reg.Cardiologic Dispensary,Cardiology Dept,Barnaul
Barnaul, 656055, Russia
Regional Clinical Hospital No.3, Cardiology Dept,Chelyabinsk
Chelyabinsk, 454021, Russia
State Instit.Kazan Fed.Univ.
Kazan', 420043, Russia
State Autonomous Healthc Insti City Clin Hosp#7,Cardio,Kazan
Kazan', 420103, Russia
Res.Inst.-Compl.Iss.Cardi.Dis.
Kemerovo, 650002, Russia
Clin.Hosp.#1na S.V.Ochapovskiy
Krasnodar, 350086, Russia
City Clin.Hosp.#15 n.a.O.M.Filatov,Cardiology Dept.#2,Moscow
Moscow, 111 539, Russia
City Clin.Hosp#51,Moscow Healthcare Dep.X-ray surgery method
Moscow, 121309, Russia
Cntr of CV Surgery na Bakulev,Surg.Treatm of Inter.Path.dept
Moscow, 121552, Russia
North-Western Fed.Med.Resear.Centr na V.I.Almazov,Cardio.dep
Saint Petersburg, 197341, Russia
City Pokrovskiy Hospital, Cardiology Dept., Saint Petersburg
Saint Petersburg, 199 106, Russia
State Budg.Healthc.Instit.Samara Reg.Clin.Cardiology Dispens
Samara, 443070, Russia
State Budg.Healthc.Instit Volgograd RegClin.Cardiology Centr
Volgograd, 400008, Russia
Cent.f.Spec.Med.C.U.Cardi.Inst
Yekaterinburg, 620144, Russia
National University Hospital
Singapore, 119228, Singapore
National Heart Center
Singapore, 169609, Singapore
Slov.Ins.Crdi.Dise.,Cor.C.U.
Banská Bystrica, 97401, Slovakia
Nat.Instit.Cardiov.Diseas,Arryhythmias&Cardiac Pacing,Bratis
Bratislava, 83348, Slovakia
East Slovak Inst.Cardi.Disea.
Košice, 04011, Slovakia
Kardiocentrum Nitra,Internal Medicine Dept, Nitra
Nitra, 94901, Slovakia
General Hospital Celje
Celje, 3000, Slovenia
General Hospital Izola, Cardiology Department
Izola, 6310, Slovenia
University Medical Center Ljubljana
Ljubljana, 1000, Slovenia
Univ. Medical Center Maribor
Maribor, 2000, Slovenia
Inje University Haeundae Paik Hospital
Busan, 612-896, South Korea
Kyungpook National Univ. Hosp
Daegu, 700-721, South Korea
Yeungnam University Medical Center
Daegu, 705-703, South Korea
Chonnam National University Hospital
Gwangju, 501-757, South Korea
Pusan National Univ. Hosp
Pusan, 602-739, South Korea
Kyung Hee University Hospital
Seoul, 02447, South Korea
The Catholic University of Korea, Seoul St.Mary's Hospital
Seoul, 06591, South Korea
Korea University Guro Hospital
Seoul, 08308, South Korea
Severance Hospital
Seoul, 120-752, South Korea
Korea University Anam Hospital
Seoul, 136-705, South Korea
St.Carollo Hospital
Suncheon, 540-719, South Korea
Ajou University Hospital
Suwon, 16499, South Korea
Wonju Severance Christian Hosp
Wŏnju, 220-701, South Korea
Hospital del Mar
Barcelona, 08003, Spain
Hospital Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clínic de Barcelona
Barcelona, 08036, Spain
Hospital de Bellvitge
L'Hospitalet Llobregat (bcn), 08907, Spain
Hospital Ramón y Cajal
Madrid, 28034, Spain
Hospital Clínico San Carlos
Madrid, 28040, Spain
Hospital La Paz
Madrid, 28046, Spain
Hospital de Manises
Manises, 46940, Spain
Hospital Virgen de la Victoria
Málaga, 29010, Spain
CS Parc Taulí
Sabadell (Barcelona), 08208, Spain
Hospital Clínico de Santiago
Santiago de Compostela, 15706, Spain
Hospital Virgen del Rocío
Seville, 41013, Spain
Hospital de Galdakao
Vizcaya, 48960, Spain
Hospital Miguel Servet
Zaragoza, 50009, Spain
Länssjukhuset, Gävle
Gävle, 801 87, Sweden
Sahlgrenska Universitetssjukhuset, Östra
Gothenburg, 416 85, Sweden
Länssjukhuset, Halmstad
Halmstad, 301 85, Sweden
Lasarettet, Helsingborg
Helsingborg, 251 87, Sweden
Universitetssjukhuset, Linköping
Linköping, 581 85, Sweden
Skånes universitetssjukhus, Lund
Lund, 221 85, Sweden
Skånes universitetssjukhus, Malmö
Malmo, 205 02, Sweden
Danderyds Sjukhus
Stockholm, 182 88, Sweden
Chang-Hua Christian Hospital
Changhua, 500, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756, Taiwan
E-Da Hospital
Kaohsiung City, 824, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
NCKUH
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Taipe Veterans General Hospital
Taipei, 11217, Taiwan
Chang Gung Memorial Hospital(TaoYuan)
Taoyuan District, 330, Taiwan
Siriraj Hospital
Bangkok, 10170, Thailand
Ramathibodi Hospital
Bangkok, 10400, Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, 50200, Thailand
Srinagarind Hospital
Khon Kaen, 40002, Thailand
Cukurova Universitesi Tip Fakultesi Kardiyoloji AnabilimDali
Adana, 01330, Turkey (Türkiye)
Türkiye Yüksek Ihtisas Egitim ve Arastirma Hastanesi
Ankara, 06100, Turkey (Türkiye)
Diskapi Yildirim Beyazit EAH
Ankara, 06110, Turkey (Türkiye)
Bursa Yuksek Ihtisas EAH
Bursa, 16330, Turkey (Türkiye)
Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
Istanbul, 34093, Turkey (Türkiye)
Istanbul Universitesi Kardiyoloji Enstitusu
Istanbul, 34096, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul, 34098, Turkey (Türkiye)
Bagcilar Egitim ve Arastirma Hastanesi
Istanbul, 34200, Turkey (Türkiye)
Medipol Mega Üniversitesi Hastanesi
Istanbul, 34214, Turkey (Türkiye)
Istanbul Mehmet Akif Ersoy Egitim ve Arastirma Hastanesi
Istanbul, 34303, Turkey (Türkiye)
Siyami Ersek Gogus Kalp ve Damar Cerrahisi Hastanesi
Istanbul, 34668, Turkey (Türkiye)
Kartal Kosuyolu Yuksek Ihtisas EAH
Istanbul, 34846, Turkey (Türkiye)
Dokuz Eylul Unv. Tip Fakultesi
Izmir, 35340, Turkey (Türkiye)
Izmir Katip Celebi Univ. EAH
Izmir, 35360, Turkey (Türkiye)
Erciyes Universitesi Tip Fakultesi Kardiyoloji Anabilim Dali
Kayseri, 38039, Turkey (Türkiye)
Ondokuz Mayis Universitesi Tip Fakultesi
Samsun, 55139, Turkey (Türkiye)
Birmingham City Hospital
Birmingham, B18 7QH, United Kingdom
Royal Bournemouth and Christchurch Hospital
Bournemouth, BH7 7DW, United Kingdom
Royal Derby Hospital
Derby, DE22 3NE, United Kingdom
Dorset County Hospital
Dorchester, DT1 2JY, United Kingdom
Grantham District Hospital
Grantham, NG31 8DG, United Kingdom
Wycombe General Hospital
High Wycombe, HP11 2TT, United Kingdom
Glenfield Hospital
Leicester, LE3 9QP, United Kingdom
Lincoln County Hospital
Lincoln, LN2 5QY, United Kingdom
St Bartholomew's Hospital
London, EC1A 7BE, United Kingdom
Altnagelvin Area Hospital
Londonderry, BT47 6SB, United Kingdom
James Cook University Hospital
Middlesbrough, TS4 3BW, United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, ST4 6QG, United Kingdom
Related Publications (6)
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.
PMID: 32562206DERIVEDDe 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.
PMID: 32389658DERIVEDBerry 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.
PMID: 32252548DERIVEDHohnloser 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.
PMID: 31439336DERIVEDChi 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.
PMID: 30015064DERIVEDCannon 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.
PMID: 28844193DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Center
- Organization
- Boehringer Ingelheim
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2014
First Posted
June 17, 2014
Study Start
July 22, 2014
Primary Completion
June 5, 2017
Study Completion
June 5, 2017
Last Updated
July 31, 2018
Results First Posted
July 31, 2018
Record last verified: 2018-07