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

NCT ID: NCT02164864

Last Updated: 2018-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2725 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-22
• Study Completion Date: 2017-06-05

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.

Conditions

Atrial Fibrillation; Percutaneous Coronary Intervention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dabigatran Etexilate 110mg

Patient to receive Dabigatran Etexilate 110mg twice a day (BID)

Group Type: EXPERIMENTAL

Dabigatran Etexilate 110mg

Intervention Type: DRUG

Active treatment

Clopidogrel or Ticagrelor

Intervention Type: DRUG

Active comparator

Dabigatran Etexilate 150mg

Patient to receive Dabigatran Etexilate 150mg twice a day (BID)

Group Type: EXPERIMENTAL

Dabigatran Etexilate 150mg

Intervention Type: DRUG

Active treatment

Clopidogrel or Ticagrelor

Intervention Type: DRUG

Active comparator

Warfarin

Warfarin doses to maintain INR

Group Type: ACTIVE_COMPARATOR

Warfarin 3mg

Intervention Type: DRUG

Active comparator

Aspirin

Intervention Type: DRUG

Active comparator

Clopidogrel or Ticagrelor

Intervention Type: DRUG

Active comparator

Warfarin 5mg

Intervention Type: DRUG

Active comparator

Warfarin 1mg

Intervention Type: DRUG

Active comparator

Interventions

Dabigatran Etexilate 110mg

Active treatment

Intervention Type: DRUG

Warfarin 3mg

Active comparator

Intervention Type: DRUG

Aspirin

Active comparator

Intervention Type: DRUG

Dabigatran Etexilate 150mg

Active treatment

Intervention Type: DRUG

Clopidogrel or Ticagrelor

Active comparator

Intervention Type: DRUG

Clopidogrel or Ticagrelor

Active comparator

Intervention Type: DRUG

Warfarin 5mg

Active comparator

Intervention Type: DRUG

Clopidogrel or Ticagrelor

Active comparator

Intervention Type: DRUG

Warfarin 1mg

Active comparator

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Cardiology P.C.

Birmingham, Alabama, United States

Verde Valley Medical Center

Cottonwood, Arizona, United States

Cardiovascular Associates of Mesa

Mesa, Arizona, United States

HonorHealth Research Institute

Scottsdale, Arizona, United States

Arkansas Cardiology, PA

Little Rock, Arkansas, United States

Mission Cardiovascular Research Institute

Fremont, California, United States

Aurora Denver Cardiology Associates, PC

Aurora, Colorado, United States

University of Florida College of Medicine

Jacksonville, Florida, United States

Watson Clinic, LLP

Lakeland, Florida, United States

Community Clinical Research Center

Anderson, Indiana, United States

Midwest Cardiovascular Research and Education Foundation

Elkhart, Indiana, United States

Ball Memorial Hospital

Muncie, Indiana, United States

Richmond Cardiology Associates Research, LLC

Richmond, Indiana, United States

Cardiovascular Institute of the South

Houma, Louisiana, United States

Maine Medical Center

Portland, Maine, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Cape Cod Research Institute

Hyannis, Massachusetts, United States

Mid Michigan Medical Center

Midland, Michigan, United States

Covenant Medical Center, Inc.

Saginaw, Michigan, United States

Saint Mary's Medical Center dba Essentia Health Saint Mary's Medical Center

Duluth, Minnesota, United States

CentraCare Heart and Vascular Center

Saint Cloud, Minnesota, United States

Kansas City Veterans Administration Medical Center

Kansas City, Missouri, United States

Saint Anthony's Medical Center

St Louis, Missouri, United States

St. Michaels Medical Center

Newark, New Jersey, United States

Lourdes Cardiology Services

Voorhees Township, New Jersey, United States

VA Western New York Healthcare System

Buffalo, New York, United States

Novant Health Heart and Vascular Institute

Charlotte, North Carolina, United States

Altru Health System

Grand Forks, North Dakota, United States

Cardiovascular Research Center

Toledo, Ohio, United States

Chambersburg Hospital

Chambersburg, Pennsylvania, United States

Pinnacle Health Harrisburg Hospital

Harrisburg, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Chattanooga Heart Institute

Chattanooga, Tennessee, United States

The Jackson Clinic, PA

Jackson, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Dallas VA Medical Center

Dallas, Texas, United States

North Dallas Research Associates

McKinney, Texas, United States

Scott and White Healthcare

Round Rock, Texas, United States

South Texas Cardiovascular Consultants

San Antonio, Texas, United States

Wichita Falls Heart Clinic

Wichita Falls, Texas, United States

University of Utah Health Sciences Center

Salt Lake City, Utah, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Bayview Physicians Services PC dba Cardiovascular Associates

Virginia Beach, Virginia, United States

Holy Family Memorial, Inc

Manitowoc, Wisconsin, United States

Fundación Favaloro

CABA, , Argentina

Hospital Italiano de Buenos Aires

CABA, , Argentina

Instituto Cardiovascular de Buenos Aires

CABA, , Argentina

Consultorios Asociados de Endocrinología e Invest Clínica

Capital Federal, , Argentina

Instituto de Cardiología de Corrientes

Corrientes, , Argentina

Sanatorio Allende

Córdoba, , Argentina

Instituto CER

Quilmes, , Argentina

Inst.Cardiovascular San Luis

San Luis, , Argentina

Investigaciones Clinicas Tucumán

San Miguel de Tucumán, , Argentina

Pendlebury Research

Adamstown, New South Wales, Australia

Gosford Hospital

Gosford, New South Wales, Australia

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Wollongong Hospital

Wollongong, New South Wales, Australia

The Prince Charles Hospital

Chermside, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Heartcare Victoria

Bundoora, Victoria, Australia

The Geelong Hospital

Geelong, Victoria, Australia

Order Hospital Elisabethinen Linz

Linz, , Austria

LKH Salzburg, Univ. Clinic

Salzburg, , Austria

Wilhelminenspital

Vienna, , Austria

Aalst - HOSP Onze-Lieve-Vrouw

Aalst, , Belgium

Bonheiden - HOSP Imelda

Bonheiden, , Belgium

Brussels-UNIV Brugmann -Horta

Brussels, , Belgium

Brussels - UNIV UZ Brussel

Brussels, , Belgium

AZ Sint-Lucas - Campus Sint Lucas

Ghent, , Belgium

Charleroi - HOSP St-Joseph

Gilly, , Belgium

Ziekenhuis Netwerk Antwerpen (ZNA) - Campus Middelheim

Middelheim, , Belgium

Sint-Niklaas - HOSP AZ Nikolaas (Campus St-Niklaas)

Sint-Niklaas, , Belgium

Tienen - PRAC De Wolf, Axel

Tienen, , Belgium

Brussels - HOSP Europe (Ste-Elisabeth)

Uccle, , Belgium

Hospital Santa Isabel

Blumenau, , Brazil

Irmandade da Santa Casa de Misericordia de Curitiba

Campina Grande do Sul, , Brazil

Instituto de Cardiologia Rio Grande do Sul

Porto Alegre, , Brazil

Hospital de Base - Fac Med de Sao Jose do Rio Preto

São José do Rio Preto, , Brazil

Instituto Dante Pazzanese de Cardiologia

São Paulo, , Brazil

Hospital Sao Paulo - UNIFESP

São Paulo, , Brazil

INCOR e Hospital das Clínicas da Universidade de São Paulo

São Paulo, , Brazil

Eurolatino pesquisas Médicas Ltda

Uberlândia, , Brazil

MHAT "Deva Maria", Dept. of Cardiology, Burgas

Burgas, , Bulgaria

SHAT in Cardiology EAD, Pleven

Pleven, , Bulgaria

MHAT"Sv.Georgi",Cardi.Clin.

Plovdiv, , Bulgaria

MHAT "Sv. Vrach" EOOD, Cardiology Dept., Sandanski

Sandanski, , Bulgaria

City Clin.Univ.MPHAT EOOD,Clin.of Cardiology, Sofia

Sofia, , Bulgaria

Specialized Hosp.f.Active Treatment, Cardiology Dept, Yambol

Yambol, , Bulgaria

Calgary Heart Centre

Calgary, Alberta, Canada

St. Boniface General Hospital

Winnipeg, Manitoba, Canada

Dr. R. Labonte Prof. Med. Corp

Greater Sudbury, Ontario, Canada

Hamilton General Hospital

Hamilton, Ontario, Canada

Kawartha Cardiology Clinical Trials

Peterborough, Ontario, Canada

Thunder Bay Regional Health Science Centre

Thunder Bay, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Royal Victoria Hospital

Montreal, Quebec, Canada

CHUS Fleurimont

Sherbrooke, Quebec, Canada

IUCPQ (Laval University)

Ste-Foy, Quebec, Canada

Hospital San Juan de Dios

Santiago, , Chile

Centro de Estudios Clinicos Barros Luco

Santiago, , Chile

Hospital Las Higueras

Talcahuano, , Chile

CECMI Ltda

Temuco, , Chile

Fundación Clínica Abood Shaio

Bogotá, , Colombia

Fundación Santa Fe de Bogotá

Bogotá, , Colombia

Centro Médico Imbanaco de Cali S.A.

Cali, , Colombia

Fundación Valle de Lili

Cali, , Colombia

Fundación Cardiovascular de Colombia

Floridablanca, , Colombia

Hospital Pablo Tobón Uribe

Medellín, , Colombia

Clincal Hospital Centre Rijeka

Rijeka, , Croatia

Clinical Hosp.Merkur,Clin.Internal Med,Cardiology Dep,Zagreb

Zagreb, , Croatia

Clinical Hospital Sstre Milosrdnice, Cardiology Dept, Zagreb

Zagreb, , Croatia

University hospital center Zagreb

Zagreb, , Croatia

University Hospital Dubrava

Zagreb, , Croatia

Amkardia, s.r.o. Brno

Brno, , Czechia

Hospital Jihlava

Jihlava, , Czechia

Karlovarska Reg.Hosp, Cardiology Dept, Karlovy Vary

Karlovy Vary, , Czechia

University Hospital Olomouc

Olomouc, , Czechia

Municipal Hospital Ostrava

Ostrava, , Czechia

General Faculty Hospital, Prague

Prague, , Czechia

Institute for Clinical and Experimental Medicine

Prague, , Czechia

University Hospital Motol

Prague, , Czechia

Hospital Slany, Internal Department

Slaný, , Czechia

Hospitals of Pardubice Region, Internal Department, Svitavy

Svitavy, , Czechia

Masaryk Hospital, Usti nad Labem

Ústí nad Labem, , Czechia

Hosp.of Pardubice Reg,Orlickoustecka,Internal Dept, Ustinad

Ústí nad Orlicí, , Czechia

Aarhus Universitetshospital

Århus N, , Denmark

HYKS, Kardiologian klinikka, Sydän- ja keuhkokeskus

Helsinki, , Finland

StudyCor Oy

Jyväskylä, , Finland

Keski-Pohjanmaan keskussairaala, Kardiologian pkl, Kokkola

Kokkola, , Finland

TYKS

Turku, , Finland

HOP Ambroise Paré

Boulogne-Billancourt, , France

HOP de la Cavale Blanche

Brest, , France

HOP Gabriel-Montpied

Clermont-Ferrand, , France

HOP CHU de Grenoble

Grenoble, , France

HOP St Joseph

Marseille, , France

CLI du Pont de Chaume

Montauban, , France

HOP Arnaud de Villeneuve

Montpellier, , France

HOP Pasteur

Nice, , France

HOP Lariboisière

Paris, , France

HOP Salpêtrière, Cardio, Paris

Paris, , France

CLI Saint-Hilaire

Rouen, , France

HOP Rangueil

Toulouse, , France

SLK-Kliniken Heilbronn GmbH

Bad Friedrichshall, , Germany

Kerckhoff-Klinik, Bad Nauheim

Bad Nauheim, , Germany

Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen

Bad Oeynhausen, , Germany

CIMS Studienzentrum Bamberg GmbH

Bamberg, , Germany

Vivantes Netzwerk für Gesundheit GmbH

Berlin, , Germany

Charité - Universitätsmedizin Berlin

Berlin, , Germany

Vivantes Netzwerk für Gesundheit GmbH

Berlin, , Germany

Charité - Universitätsmedizin Berlin

Berlin, , Germany

Klinikum Bielefeld gGmbH

Bielefeld, , Germany

St. Josef- und St. Elisabeth-Hospital gGmbH

Bochum, , Germany

Universitätsklinikum Bonn AöR

Bonn, , Germany

Allgemeines Krankenhaus, Celle

Celle, , Germany

Klinikum Coburg gGmbH

Coburg, , Germany

Helios Amper-Klinikum Dachau

Dachau, , Germany

St. Johannes Hospital Dortmund

Dortmund, , Germany

Städtisches Klinikum Dresden

Dresden, , Germany

Praxisklinik Herz und Gefäße

Dresden, , Germany

Evangelisches Krankenhaus Düsseldorf

Düsseldorf, , Germany

Agaplesion Markus Krankenhaus

Frankfurt, , Germany

Universitätsklinikum Frankfurt

Frankfurt, , Germany

Städtisches Klinikum, Fulda

Fulda, , Germany

Herz- und Gefäßzentrum (HGZ-Göttingen) am Krankenhaus Neu Bethlehem

Göttingen, , Germany

Universitätsmedizin Göttingen, Georg-August-Universität

Göttingen, , Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Cardiologicum Hamburg

Hamburg, , Germany

Westküstenkliniken Brunsbüttel und Heide gGmbH

Heide, , Germany

HPK-Heidelberger Praxisklinik

Heidelberg, , Germany

Universitätsklinikum des Saarlandes

Homburg/Saar, , Germany

Universitätsklinikum Jena

Jena, , Germany

Universitätsklinikum Schleswig-Holstein, Campus Kiel

Kiel, , Germany

Asklepios Klinik Langen-Seligenstadt GmbH

Langen, , Germany

Herzzentrum Leipzig GmbH

Leipzig, , Germany

Klinikum der Stadt Ludwigshafen am Rhein gGmbH

Ludwigshafen, , Germany

Märkische Gesundheitsholding GmbH & Co. KG, Klinikum Lüdenscheid

Lüdenscheid, , Germany

Universitätsklinikum Magdeburg AöR

Magdeburg, , Germany

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, , Germany

Universitätsklinikum Mannheim GmbH

Mannheim, , Germany

Carl-von-Basedow Klinikum Saalekreis gGmgH

Merseburg, , Germany

Klinikum der Universität München - Campus Großhadern

München, , Germany

Städtisches Klinikum München GmbH

München, , Germany

Städtisches Klinikum München GmbH

München, , Germany

Universitätsklinikum Münster

Münster, , Germany

St. Vincenz-Krankenhaus GmbH

Paderborn, , Germany

Sana-Klinikum Remscheid GmbH

Remscheid, , Germany

Universitätsmedizin Rostock

Rostock, , Germany

Robert-Bosch-Krankenhaus GmbH

Stuttgart, , Germany

Universitätsklinikum Tübingen

Tübingen, , Germany

Universitätsklinikum Ulm

Ulm, , Germany

Marien-Hospital-Wesel gGmbH

Wesel, , Germany

Helios Universitätsklinikum Wuppertal

Wuppertal, , Germany

University Hospital of Alexandroupolis

Alexandroupoli, , Greece

Hippokration Hospital, Univ Clinic of Cardiology

Athens, , Greece

General Hospital of Athens "Alexandra"

Athens, , Greece

General Hospital of Athens Konstantopoulio-Agia Olga

Athens, , Greece

General Hospital of Attica "Sismanoglio - Amalia Fleming"

Athens, , Greece

General Hospital of Chios, Department of Cardiology

Chios, , Greece

University General Hospital of Heraklion

Heraklion, Crete, , Greece

Univ. Gen. Hosp. of Ioannina

Ioannina, , Greece

University Hospital of Patras

Pátrai, , Greece

University Hospital of Thessaloniki AHEPA

Thessaloniki, , 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, , Hungary

Semmelweis University

Budapest, , Hungary

Milit.Hosp.-State Health Cent.

Budapest, , Hungary

University Debrecen Hospital

Debrecen, , Hungary

Bacs-Kiskun Megyei Onkormanyzat Hospital

Kecskemét, , Hungary

University of Pecs, Invasive Cardiology

Pécs, , Hungary

Univ. of Szeged, 2nd Dept. of Internal Med., Haematology

Szeged, , Hungary

Care Institute Of Medical Sciences

Ahmedabad, , India

Medanta- The Medicity

Gurgaon, , India

Nizam's Institute of Medical Sciences

Hyderabad, , India

B and M Patel Cardiac Centre, Shree Krishna Hospital,

Karamsad, , India

Shri Krishna Hrudayalaya and Critical Care

Nagpur, , India

Vijan Cardiac and Critical Care Centre

Nashik, , India

Fortis Escorts Heart Institute

New Delhi, , India

Byramjee Jeejeebhoy Medical College

Pune, , India

King George's Hospital,

Seemandhra, , India

Mater Misericordiae University Hospital

Dublin, , Ireland

St James's Hospital

Dublin, , Ireland

Beaumont Hospital

Dublin, , Ireland

University Hospital Galway

Galway, , Ireland

Hillel Yaffe Medical Center, Hadera

Hadera, , Israel

Rambam Medical Center

Haifa, , Israel

Wolfson Medical Center

Holon, , Israel

Shaare Zedek Medical Center, Jerusalem 91031

Jerusalem, , Israel

West.Galilee Med.Cent.Naharia

Nahariya, , Israel

Rabin Medical Center Beilinson

Petah Tikva, , Israel

Ospedale San Donato di Arezzo

Arezzo, , Italy

ASST Papa Giovanni XXIII - A.O. Papa Giovanni XXIII

Bergamo, , Italy

Fond. Poliambulanza Istituto

Brescia, , Italy

A.O.U. Policlinico Vittorio Emanuele

Catania, , Italy

Osp. Clin. SS. Anunziata

Chieti, , Italy

Ospedale "Fabrizio Spaziani"

Frosinone, , Italy

Ospedale della Misericordia

Grosseto, , Italy

Azienda Ospedaliera Vito Fazzi

Lecce, , Italy

Osp. Pediatrico Aprano Pasquinucci

Massa, , Italy

Ospedale Cardarelli

Napoli, , Italy

Pol. Universitario Tor Vergata

Roma, , Italy

Policlinico Gemelli

Roma, , Italy

Presidio Ospedaliero di Saronno

Saronno (VA), , Italy

Ospedale Bolognini

Seriate, , Italy

Ospedale Molinette, AO Città della Salute e della

Torino, , Italy

Japanese Red Cross Nagoya Daini Hospital

Aichi, Nagoya, , Japan

Hirosaki University Hospital

Aomori, Hirosaki, , Japan

Chiba University Hospital

Chiba, Chiba, , Japan

Kokura Memorial Hospital

Fukuoka, Kitakyushu, , Japan

Fukuoka-Higashi Med. Ctr. Fukuoka, CV

Fukuoka, Koga, , Japan

Shin Koga Hospital

Fukuoka, Kurume, , Japan

Gumma Prefectural Cardiovascular Center

Gunma, Maebashi, , Japan

National Hospital Organization Takasaki General Medical Center

Gunma, Takasaki, , Japan

Fukuyama Cardiovascular Hospital

Hiroshima, Fukuyama, , Japan

Tokeidai Memorial Hospital

Hokkaido, Sapporo, , Japan

National Hospital Organization Hokkaido Medical Center

Hokkaido, Sapporo, , Japan

Hyogo Brain and Heart Center

Hyogo, Himeji, , Japan

The Veritas Hospital

Hyogo, Kawanishi, , Japan

Kobe University Hospital

Hyogo, Kobe, , Japan

Takahashi Hospital

Hyogo, Kobe, , Japan

National Hospital Organization Kanazawa Medical Center

Ishikawa, Kanazawa, , Japan

Iwate Medical University Hospital

Iwate, Morioka, , Japan

Kagawa Prefectural Central Hospital

Kagawa, Takamatsu, , Japan

Shonan Fujisawa Tokushukai Hospital

Kanagawa, Fujisawa, , Japan

Kitasato University Hospital

Kanagawa, Sagamihara, , Japan

Yokohama City Minato Red Cross Hospital

Kanagawa, Yokohama, , Japan

Kyoto University Hospital

Kyoto, Kyoto, , Japan

Miyazaki Medical Association Hospital

Miyazaki, Miyazaki, , Japan

Sakurabashi Watanabe Hospital

Osaka, Osaka, , Japan

Osaka City Hospital Organization Osaka City General Hospital

Osaka, Osaka, , Japan

Sayama General Clinic

Saitama, Sayama, , Japan

National Hospital Organization Saitama National Hospital

Saitama, Wako, , Japan

Kusatsu General Hospital

Shiga, Kusatsu, , Japan

Omihachiman Community Medical Center

Shiga, Omihachiman, , Japan

Tokushima Red Cross Hospital

Tokushima, Komatsushima, , Japan

Nishiarai Heart Center Hospital

Tokyo, Adachi-ku, , Japan

Nippon Medical School Hospital

Tokyo, Bunkyo-ku, , Japan

Minamino Heart Clinic

Tokyo, Hachioji, , Japan

Teikyo University Hospital

Tokyo, Itabashi-Ku, , Japan

Nihon University Itabashi Hospital

Tokyo, Itabashi-Ku, , Japan

Itabashi Chuo Medical Center

Tokyo, Itabashi-Ku, , Japan

Global Health and Medicine Ctr

Tokyo, Shinjuku-ku, , Japan

Tokyo Women's Medical University Hospital

Tokyo, Shinjuku-ku, , Japan

Hospital Cardiologica Aguascalientes

Aguascalientes, , Mexico

Instituto Nacional de Cardiologia Ignacio Chavez

Mexico City, , Mexico

H. Central Dr Ignacio M. P.

San Luis Potosí City, , Mexico

Centro Especializado en Terapia Endovascular (CETEN)

Zapopan, Jalisco, , Mexico

Noordwest Ziekenhuisgroep

Alkmaar, , Netherlands

Catharina Ziekenhuis

Eindhoven, , Netherlands

Scheper Ziekenhuis

Emmen, , Netherlands

Admiraal de Ruyter Ziekenhuis

Goes, , Netherlands

UMCG

Groningen, , Netherlands

St. Antonius ziekenhuis, locatie Nieuwegein

Nieuwegein, , Netherlands

Canisius-Wilhelmina ziekenhuis

Nijmegen, , Netherlands

Ziekenhuis Bernhoven Uden

Uden, , Netherlands

Waikato Hospital

Hamilton, , New Zealand

Sørlandet sykehus HF, Avd. Arendal

Arendal, , Norway

Oslo Universitetssykehus HF, Ullevål sykehus

Oslo, , Norway

Oslo Universitetssykehus HF, Rikshospitalet

Oslo, , Norway

Stavanger Helseforskning

Stavanger, , Norway

Universitetssykehuset Nord-Norge, Tromsø

Tromsø, , Norway

Univ. Clinic Hosp, Bialystok

Bialystok, , Poland

10.Military Clin.Hospital&Polyclinic

Bydgoszcz, , Poland

Swissmed Vascular Sp. Z.o.o Hosp., Cardiology Dept., Gdansk

Gdansk, , Poland

University Clinical Center, Gdansk

Gdansk, , Poland

Reg.Hosp Kielce,Swietokrzyskie,1.Clinic of Cardiology,Kielce

Kielce, , Poland

Independent Public Clin.Hosp.#4, Cardiology Clinic,Lubilin

Lublin, , Poland

Independent Public Healthcare, Dept. of Cardiology, Pulawy

Puławy, , Poland

Central Hospital of Medical Academy, Warsaw

Warsaw, , Poland

Lower Silesian Spec.Hosp.T.Marciniaka,Cardiology Dep,Wroclaw

Wroclaw, , Poland

John Paul II Regional Hospital, Zamosc

Zamość, , Poland

Hospital Garcia de Orta, EPE

Almada, , Portugal

CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

Coimbra, , Portugal

Centro Hosp. de Leiria-Pombal

Leiria, , Portugal

CHLC, EPE - Hospital de Santa Marta

Lisbon, , Portugal

CHLO, EPE - Hospital de Santa Cruz

Lisbon, , Portugal

CHLN, EPE - Hospital de Santa Maria

Lisbon, , Portugal

CHUC,EPE - Hospital Geral dos Covões

S. Martinho Do Bispo,Coimbra, , Portugal

Altaiskyi Reg.Cardiologic Dispensary,Cardiology Dept,Barnaul

Barnaul, , Russia

Regional Clinical Hospital No.3, Cardiology Dept,Chelyabinsk

Chelyabinsk, , Russia

State Instit.Kazan Fed.Univ.

Kazan', , Russia

State Autonomous Healthc Insti City Clin Hosp#7,Cardio,Kazan

Kazan', , Russia

Res.Inst.-Compl.Iss.Cardi.Dis.

Kemerovo, , Russia

Clin.Hosp.#1na S.V.Ochapovskiy

Krasnodar, , Russia

City Clin.Hosp.#15 n.a.O.M.Filatov,Cardiology Dept.#2,Moscow

Moscow, , Russia

City Clin.Hosp#51,Moscow Healthcare Dep.X-ray surgery method

Moscow, , Russia

Cntr of CV Surgery na Bakulev,Surg.Treatm of Inter.Path.dept

Moscow, , Russia

North-Western Fed.Med.Resear.Centr na V.I.Almazov,Cardio.dep

Saint Petersburg, , Russia

City Pokrovskiy Hospital, Cardiology Dept., Saint Petersburg

Saint Petersburg, , Russia

State Budg.Healthc.Instit.Samara Reg.Clin.Cardiology Dispens

Samara, , Russia

State Budg.Healthc.Instit Volgograd RegClin.Cardiology Centr

Volgograd, , Russia

Cent.f.Spec.Med.C.U.Cardi.Inst

Yekaterinburg, , Russia

National University Hospital

Singapore, , Singapore

National Heart Center

Singapore, , Singapore

Slov.Ins.Crdi.Dise.,Cor.C.U.

Banská Bystrica, , Slovakia

Nat.Instit.Cardiov.Diseas,Arryhythmias&Cardiac Pacing,Bratis

Bratislava, , Slovakia

East Slovak Inst.Cardi.Disea.

Košice, , Slovakia

Kardiocentrum Nitra,Internal Medicine Dept, Nitra

Nitra, , Slovakia

General Hospital Celje

Celje, , Slovenia

General Hospital Izola, Cardiology Department

Izola, , Slovenia

University Medical Center Ljubljana

Ljubljana, , Slovenia

Univ. Medical Center Maribor

Maribor, , Slovenia

Inje University Haeundae Paik Hospital

Busan, , South Korea

Kyungpook National Univ. Hosp

Daegu, , South Korea

Yeungnam University Medical Center

Daegu, , South Korea

Chonnam National University Hospital

Gwangju, , South Korea

Pusan National Univ. Hosp

Pusan, , South Korea

Kyung Hee University Hospital

Seoul, , South Korea

The Catholic University of Korea, Seoul St.Mary's Hospital

Seoul, , South Korea

Korea University Guro Hospital

Seoul, , South Korea

Severance Hospital

Seoul, , South Korea

Korea University Anam Hospital

Seoul, , South Korea

St.Carollo Hospital

Suncheon, , South Korea

Ajou University Hospital

Suwon, , South Korea

Wonju Severance Christian Hosp

Wŏnju, , South Korea

Hospital del Mar

Barcelona, , Spain

Hospital Vall d'Hebron

Barcelona, , Spain

Hospital Clínic de Barcelona

Barcelona, , Spain

Hospital de Bellvitge

L'Hospitalet Llobregat (bcn), , Spain

Hospital Ramón y Cajal

Madrid, , Spain

Hospital Clínico San Carlos

Madrid, , Spain

Hospital La Paz

Madrid, , Spain

Hospital de Manises

Manises, , Spain

Hospital Virgen de la Victoria

Málaga, , Spain

CS Parc Taulí

Sabadell (Barcelona), , Spain

Hospital Clínico de Santiago

Santiago de Compostela, , Spain

Hospital Virgen del Rocío

Seville, , Spain

Hospital de Galdakao

Vizcaya, , Spain

Hospital Miguel Servet

Zaragoza, , Spain

Länssjukhuset, Gävle

Gävle, , Sweden

Sahlgrenska Universitetssjukhuset, Östra

Gothenburg, , Sweden

Länssjukhuset, Halmstad

Halmstad, , Sweden

Lasarettet, Helsingborg

Helsingborg, , Sweden

Universitetssjukhuset, Linköping

Linköping, , Sweden

Skånes universitetssjukhus, Lund

Lund, , Sweden

Skånes universitetssjukhus, Malmö

Malmo, , Sweden

Danderyds Sjukhus

Stockholm, , Sweden

Chang-Hua Christian Hospital

Changhua, , Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

E-Da Hospital

Kaohsiung City, , Taiwan

China Medical University Hospital

Taichung, , Taiwan

NCKUH

Tainan City, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Taipe Veterans General Hospital

Taipei, , Taiwan

Chang Gung Memorial Hospital(TaoYuan)

Taoyuan District, , Taiwan

Siriraj Hospital

Bangkok, , Thailand

Ramathibodi Hospital

Bangkok, , Thailand

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, , Thailand

Srinagarind Hospital

Khon Kaen, , Thailand

Cukurova Universitesi Tip Fakultesi Kardiyoloji AnabilimDali

Adana, , Turkey (Türkiye)

Türkiye Yüksek Ihtisas Egitim ve Arastirma Hastanesi

Ankara, , Turkey (Türkiye)

Diskapi Yildirim Beyazit EAH

Ankara, , Turkey (Türkiye)

Bursa Yuksek Ihtisas EAH

Bursa, , Turkey (Türkiye)

Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

Istanbul, , Turkey (Türkiye)

Istanbul Universitesi Kardiyoloji Enstitusu

Istanbul, , Turkey (Türkiye)

Istanbul Universitesi Cerrahpasa Tip Fakultesi

Istanbul, , Turkey (Türkiye)

Bagcilar Egitim ve Arastirma Hastanesi

Istanbul, , Turkey (Türkiye)

Medipol Mega Üniversitesi Hastanesi

Istanbul, , Turkey (Türkiye)

Istanbul Mehmet Akif Ersoy Egitim ve Arastirma Hastanesi

Istanbul, , Turkey (Türkiye)

Siyami Ersek Gogus Kalp ve Damar Cerrahisi Hastanesi

Istanbul, , Turkey (Türkiye)

Kartal Kosuyolu Yuksek Ihtisas EAH

Istanbul, , Turkey (Türkiye)

Dokuz Eylul Unv. Tip Fakultesi

Izmir, , Turkey (Türkiye)

Izmir Katip Celebi Univ. EAH

Izmir, , Turkey (Türkiye)

Erciyes Universitesi Tip Fakultesi Kardiyoloji Anabilim Dali

Kayseri, , Turkey (Türkiye)

Ondokuz Mayis Universitesi Tip Fakultesi

Samsun, , Turkey (Türkiye)

Birmingham City Hospital

Birmingham, , United Kingdom

Royal Bournemouth and Christchurch Hospital

Bournemouth, , United Kingdom

Royal Derby Hospital

Derby, , United Kingdom

Dorset County Hospital

Dorchester, , United Kingdom

Grantham District Hospital

Grantham, , United Kingdom

Wycombe General Hospital

High Wycombe, , United Kingdom

Glenfield Hospital

Leicester, , United Kingdom

Lincoln County Hospital

Lincoln, , United Kingdom

St Bartholomew's Hospital

London, , United Kingdom

Altnagelvin Area Hospital

Londonderry, , United Kingdom

James Cook University Hospital

Middlesbrough, , United Kingdom

Royal Stoke University Hospital

Stoke-on-Trent, , United Kingdom

Countries

United States; Argentina; Australia; Austria; Belgium; Brazil; Bulgaria; Canada; Chile; Colombia; Croatia; Czechia; Denmark; Finland; France; Germany; Greece; Hong Kong; Hungary; India; Ireland; Israel; Italy; Japan; Mexico; Netherlands; New Zealand; Norway; Poland; Portugal; Russia; Singapore; Slovakia; Slovenia; South Korea; Spain; Sweden; Taiwan; Thailand; Turkey (Türkiye); United Kingdom

References

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.

Reference Type: DERIVED

PMID: 32562206 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32389658 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32252548 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31439336 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30015064 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28844193 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2013-003201-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1160.186

Identifier Type: -

Identifier Source: org_study_id