AzTrials
AzTrials

Atrial FibrillationPhase 3NCT02164864

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

A Phase 3 study testing Dabigatran Etexilate 110mg, Warfarin 3mg and Aspirin in people with Atrial Fibrillation and Percutaneous Coronary Intervention, run by Boehringer Ingelheim at 421 sites in 41 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dabigatran Etexilate 110mg, Warfarin 3mg and Aspirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,725 participants
Where
421 sitesin 41 countries
Study dates
22 Jul 2014to 5 Jun 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

421 sites in 41 countries.

421 sites in 41 countries

Germany50 sites

  • SLK-Kliniken Heilbronn GmbH

    Bad Friedrichshall, 74177

  • Kerckhoff-Klinik, Bad Nauheim

    Bad Nauheim, 61231

  • Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen

    Bad Oeynhausen, 32545

  • CIMS Studienzentrum Bamberg GmbH

    Bamberg, 96049

  • Vivantes Netzwerk für Gesundheit GmbH

    Berlin, 10967

  • Charité - Universitätsmedizin Berlin

    Berlin, 12200

  • Vivantes Netzwerk für Gesundheit GmbH

    Berlin, 12351

  • Charité - Universitätsmedizin Berlin

    Berlin, 13353

  • Klinikum Bielefeld gGmbH

    Bielefeld, 33604

  • St. Josef- und St. Elisabeth-Hospital gGmbH

    Bochum, 44791

  • Universitätsklinikum Bonn AöR

    Bonn, 53127

  • Allgemeines Krankenhaus, Celle

    Celle, 29223

  • Klinikum Coburg gGmbH

    Coburg, 96450

  • Helios Amper-Klinikum Dachau

    Dachau, 85221

  • St. Johannes Hospital Dortmund

    Dortmund, 44137

  • Städtisches Klinikum Dresden

    Dresden, 01067

  • Praxisklinik Herz und Gefäße

    Dresden, 01324

  • Evangelisches Krankenhaus Düsseldorf

    Düsseldorf, 40217

  • Agaplesion Markus Krankenhaus

    Frankfurt, 60431

  • Universitätsklinikum Frankfurt

    Frankfurt, 60590

  • Städtisches Klinikum, Fulda

    Fulda, 36043

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

    Göttingen, 37073

  • Universitätsmedizin Göttingen, Georg-August-Universität

    Göttingen, 37075

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Cardiologicum Hamburg

    Hamburg, 22041

  • Westküstenkliniken Brunsbüttel und Heide gGmbH

    Heide, 25746

  • HPK-Heidelberger Praxisklinik

    Heidelberg, 69115

  • Universitätsklinikum des Saarlandes

    Homburg/Saar, 66421

  • Universitätsklinikum Jena

    Jena, 07740

  • Universitätsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, 24105

  • Asklepios Klinik Langen-Seligenstadt GmbH

    Langen, 63225

  • Herzzentrum Leipzig GmbH

    Leipzig, 04289

  • Märkische Gesundheitsholding GmbH & Co. KG, Klinikum Lüdenscheid

    Lüdenscheid, 58515

  • Klinikum der Stadt Ludwigshafen am Rhein gGmbH

    Ludwigshafen, 67063

  • Universitätsklinikum Magdeburg AöR

    Magdeburg, 39120

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131

  • Universitätsklinikum Mannheim GmbH

    Mannheim, 68167

  • Carl-von-Basedow Klinikum Saalekreis gGmgH

    Merseburg, 06217

  • Klinikum der Universität München - Campus Großhadern

    München, 81377

  • Städtisches Klinikum München GmbH

    München, 81737

  • Städtisches Klinikum München GmbH

    München, 81925

  • Universitätsklinikum Münster

    Münster, 48149

  • St. Vincenz-Krankenhaus GmbH

    Paderborn, 33098

  • Sana-Klinikum Remscheid GmbH

    Remscheid, 42859

  • Universitätsmedizin Rostock

    Rostock, 18057

  • Robert-Bosch-Krankenhaus GmbH

    Stuttgart, 70376

  • Universitätsklinikum Tübingen

    Tübingen, 72076

  • Universitätsklinikum Ulm

    Ulm, 89081

  • Marien-Hospital-Wesel gGmbH

    Wesel, 46483

  • Helios Universitätsklinikum Wuppertal

    Wuppertal, 42117

Other trials in Germany

United States45 sites

  • Community Clinical Research Center

    Anderson, Indiana, 46011

  • Aurora Denver Cardiology Associates, PC

    Aurora, Colorado, 80012

  • Cardiology P.C.

    Birmingham, Alabama, 35211

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • VA Western New York Healthcare System

    Buffalo, New York, 14215

  • Chambersburg Hospital

    Chambersburg, Pennsylvania, 17201

  • Novant Health Heart and Vascular Institute

    Charlotte, North Carolina, 28204

  • Chattanooga Heart Institute

    Chattanooga, Tennessee, 37404

  • Verde Valley Medical Center

    Cottonwood, Arizona, 86326

  • Dallas VA Medical Center

    Dallas, Texas, 75216

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

    Duluth, Minnesota, 55805

  • Midwest Cardiovascular Research and Education Foundation

    Elkhart, Indiana, 46514

  • Mission Cardiovascular Research Institute

    Fremont, California, 94538

  • Altru Health System

    Grand Forks, North Dakota, 58201

  • Pinnacle Health Harrisburg Hospital

    Harrisburg, Pennsylvania, 17101

  • Cardiovascular Institute of the South

    Houma, Louisiana, 70360

  • Cape Cod Research Institute

    Hyannis, Massachusetts, 02601

  • The Jackson Clinic, PA

    Jackson, Tennessee, 38301

  • University of Florida College of Medicine

    Jacksonville, Florida, 32209

  • Kansas City Veterans Administration Medical Center

    Kansas City, Missouri, 64128

  • Watson Clinic, LLP

    Lakeland, Florida, 33805

  • Arkansas Cardiology, PA

    Little Rock, Arkansas, 72205

  • Holy Family Memorial, Inc

    Manitowoc, Wisconsin, 54220

  • North Dallas Research Associates

    McKinney, Texas, 75069

  • Cardiovascular Associates of Mesa

    Mesa, Arizona, 85206

  • Mid Michigan Medical Center

    Midland, Michigan, 48670

  • Ball Memorial Hospital

    Muncie, Indiana, 47303

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232-8802

  • St. Michaels Medical Center

    Newark, New Jersey, 07102

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Maine Medical Center

    Portland, Maine, 04102

  • Richmond Cardiology Associates Research, LLC

    Richmond, Indiana, 47374

  • Scott and White Healthcare

    Round Rock, Texas, 78665

  • Covenant Medical Center, Inc.

    Saginaw, Michigan, 48602

  • CentraCare Heart and Vascular Center

    Saint Cloud, Minnesota, 56303

  • University of Utah Health Sciences Center

    Salt Lake City, Utah, 84132

  • South Texas Cardiovascular Consultants

    San Antonio, Texas, 78201

  • HonorHealth Research Institute

    Scottsdale, Arizona, 85258

  • Saint Anthony's Medical Center

    St Louis, Missouri, 63128

  • Cardiovascular Research Center

    Toledo, Ohio, 43608

  • Bayview Physicians Services PC dba Cardiovascular Associates

    Virginia Beach, Virginia, 23454

  • Lourdes Cardiology Services

    Voorhees Township, New Jersey, 08043

  • Wichita Falls Heart Clinic

    Wichita Falls, Texas, 76301

Other trials in United States

Japan38 sites

  • Japanese Red Cross Nagoya Daini Hospital

    Aichi, Nagoya, 466-8650

  • Hirosaki University Hospital

    Aomori, Hirosaki, 036-8563

  • Chiba University Hospital

    Chiba, Chiba, 260-8677

  • Kokura Memorial Hospital

    Fukuoka, Kitakyushu, 802-8555

  • Fukuoka-Higashi Med. Ctr. Fukuoka, CV

    Fukuoka, Koga, 811-3195

  • Shin Koga Hospital

    Fukuoka, Kurume, 830-8577

  • Gumma Prefectural Cardiovascular Center

    Gunma, Maebashi, 371-0004

  • National Hospital Organization Takasaki General Medical Center

    Gunma, Takasaki, 370-0829

  • Fukuyama Cardiovascular Hospital

    Hiroshima, Fukuyama, 720-0804

  • Tokeidai Memorial Hospital

    Hokkaido, Sapporo, 060-0031

  • National Hospital Organization Hokkaido Medical Center

    Hokkaido, Sapporo, 063-0005

  • Hyogo Brain and Heart Center

    Hyogo, Himeji, 670-0981

  • The Veritas Hospital

    Hyogo, Kawanishi, 666-0125

  • Kobe University Hospital

    Hyogo, Kobe, 650-0017

  • Takahashi Hospital

    Hyogo, Kobe, 654-0026

  • National Hospital Organization Kanazawa Medical Center

    Ishikawa, Kanazawa, 920-8650

  • Iwate Medical University Hospital

    Iwate, Morioka, 020-8505

  • Kagawa Prefectural Central Hospital

    Kagawa, Takamatsu, 760-8557

  • Shonan Fujisawa Tokushukai Hospital

    Kanagawa, Fujisawa, 251-0041

  • Kitasato University Hospital

    Kanagawa, Sagamihara, 252-0375

  • Yokohama City Minato Red Cross Hospital

    Kanagawa, Yokohama, 231-8682

  • Kyoto University Hospital

    Kyoto, Kyoto, 606-8507

  • Miyazaki Medical Association Hospital

    Miyazaki, Miyazaki, 880-0834

  • Sakurabashi Watanabe Hospital

    Osaka, Osaka, 530-0001

  • Osaka City Hospital Organization Osaka City General Hospital

    Osaka, Osaka, 534-0021

  • Sayama General Clinic

    Saitama, Sayama, 350-1305

  • National Hospital Organization Saitama National Hospital

    Saitama, Wako, 351-0102

  • Kusatsu General Hospital

    Shiga, Kusatsu, 525-8585

  • Omihachiman Community Medical Center

    Shiga, Omihachiman, 523-0082

  • Tokushima Red Cross Hospital

    Tokushima, Komatsushima, 773-8502

  • Nishiarai Heart Center Hospital

    Tokyo, Adachi-ku, 123-0845

  • Nippon Medical School Hospital

    Tokyo, Bunkyo-ku, 113-8603

  • Minamino Heart Clinic

    Tokyo, Hachioji, 192-0918

  • Teikyo University Hospital

    Tokyo, Itabashi-Ku, 173-8606

  • Nihon University Itabashi Hospital

    Tokyo, Itabashi-Ku, 173-8610

  • Itabashi Chuo Medical Center

    Tokyo, Itabashi-Ku, 174-0051

  • Global Health and Medicine Ctr

    Tokyo, Shinjuku-ku, 162-8655

  • Tokyo Women's Medical University Hospital

    Tokyo, Shinjuku-ku, 162-8666

Other trials in Japan

Turkey (Türkiye)16 sites

  • Cukurova Universitesi Tip Fakultesi Kardiyoloji AnabilimDali

    Adana, 01330

  • Türkiye Yüksek Ihtisas Egitim ve Arastirma Hastanesi

    Ankara, 06100

  • Diskapi Yildirim Beyazit EAH

    Ankara, 06110

  • Bursa Yuksek Ihtisas EAH

    Bursa, 16330

  • Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

    Istanbul, 34093

  • Istanbul Universitesi Kardiyoloji Enstitusu

    Istanbul, 34096

  • Istanbul Universitesi Cerrahpasa Tip Fakultesi

    Istanbul, 34098

  • Bagcilar Egitim ve Arastirma Hastanesi

    Istanbul, 34200

  • Medipol Mega Üniversitesi Hastanesi

    Istanbul, 34214

  • Istanbul Mehmet Akif Ersoy Egitim ve Arastirma Hastanesi

    Istanbul, 34303

  • Siyami Ersek Gogus Kalp ve Damar Cerrahisi Hastanesi

    Istanbul, 34668

  • Kartal Kosuyolu Yuksek Ihtisas EAH

    Istanbul, 34846

  • Dokuz Eylul Unv. Tip Fakultesi

    Izmir, 35340

  • Izmir Katip Celebi Univ. EAH

    Izmir, 35360

  • Erciyes Universitesi Tip Fakultesi Kardiyoloji Anabilim Dali

    Kayseri, 38039

  • Ondokuz Mayis Universitesi Tip Fakultesi

    Samsun, 55139

Other trials in Turkey (Türkiye)

Italy15 sites

  • Ospedale San Donato di Arezzo

    Arezzo, 52100

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

    Bergamo, 24127

  • Fond. Poliambulanza Istituto

    Brescia, 25100

  • A.O.U. Policlinico Vittorio Emanuele

    Catania, 95124

  • Osp. Clin. SS. Anunziata

    Chieti, 66100

  • Ospedale "Fabrizio Spaziani"

    Frosinone, 03100

  • Ospedale della Misericordia

    Grosseto, 58100

  • Azienda Ospedaliera Vito Fazzi

    Lecce, 73100

  • Osp. Pediatrico Aprano Pasquinucci

    Massa, 54100

  • Ospedale Cardarelli

    Naples, 80131

  • Pol. Universitario Tor Vergata

    Roma, 00133

  • Policlinico Gemelli

    Roma, 00195

  • Presidio Ospedaliero di Saronno

    Saronno (VA), 21047

  • Ospedale Bolognini

    Seriate, 24068

  • Ospedale Molinette, AO Città della Salute e della

    Torino, 10126

Other trials in Italy

Russia14 sites

  • Altaiskyi Reg.Cardiologic Dispensary,Cardiology Dept,Barnaul

    Barnaul, 656055

  • Regional Clinical Hospital No.3, Cardiology Dept,Chelyabinsk

    Chelyabinsk, 454021

  • State Instit.Kazan Fed.Univ.

    Kazan', 420043

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

    Kazan', 420103

  • Res.Inst.-Compl.Iss.Cardi.Dis.

    Kemerovo, 650002

  • Clin.Hosp.#1na S.V.Ochapovskiy

    Krasnodar, 350086

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

    Moscow, 111 539

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

    Moscow, 121309

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

    Moscow, 121552

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

    Saint Petersburg, 197341

  • City Pokrovskiy Hospital, Cardiology Dept., Saint Petersburg

    Saint Petersburg, 199 106

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

    Samara, 443070

  • State Budg.Healthc.Instit Volgograd RegClin.Cardiology Centr

    Volgograd, 400008

  • Cent.f.Spec.Med.C.U.Cardi.Inst

    Yekaterinburg, 620144

Other trials in Russia

Spain14 sites

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital Clínic de Barcelona

    Barcelona, 08036

  • Hospital de Bellvitge

    L'Hospitalet Llobregat (bcn), 08907

  • Hospital Ramón y Cajal

    Madrid, 28034

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Hospital La Paz

    Madrid, 28046

  • Hospital Virgen de la Victoria

    Málaga, 29010

  • Hospital de Manises

    Manises, 46940

  • CS Parc Taulí

    Sabadell (Barcelona), 08208

  • Hospital Clínico de Santiago

    Santiago de Compostela, 15706

  • Hospital Virgen del Rocío

    Seville, 41013

  • Hospital de Galdakao

    Vizcaya, 48960

  • Hospital Miguel Servet

    Zaragoza, 50009

Other trials in Spain

South Korea13 sites

  • Inje University Haeundae Paik Hospital

    Busan, 612-896

  • Kyungpook National Univ. Hosp

    Daegu, 700-721

  • Yeungnam University Medical Center

    Daegu, 705-703

  • Chonnam National University Hospital

    Gwangju, 501-757

  • Pusan National Univ. Hosp

    Pusan, 602-739

  • Kyung Hee University Hospital

    Seoul, 02447

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

    Seoul, 06591

  • Korea University Guro Hospital

    Seoul, 08308

  • Severance Hospital

    Seoul, 120-752

  • Korea University Anam Hospital

    Seoul, 136-705

  • St.Carollo Hospital

    Suncheon, 540-719

  • Ajou University Hospital

    Suwon, 16499

  • Wonju Severance Christian Hosp

    Wŏnju, 220-701

Other trials in South Korea

Czechia12 sites

  • Amkardia, s.r.o. Brno

    Brno, 63900

  • Hospital Jihlava

    Jihlava, 586 33

  • Karlovarska Reg.Hosp, Cardiology Dept, Karlovy Vary

    Karlovy Vary, 36001

  • University Hospital Olomouc

    Olomouc, 775 20

  • Municipal Hospital Ostrava

    Ostrava, 728 80

  • General Faculty Hospital, Prague

    Prague, 128 08

  • Institute for Clinical and Experimental Medicine

    Prague, 140 21

  • University Hospital Motol

    Prague, 150 06

  • Hospital Slany, Internal Department

    Slaný, 274 01

  • Hospitals of Pardubice Region, Internal Department, Svitavy

    Svitavy, 568 25

  • Masaryk Hospital, Usti nad Labem

    Ústí nad Labem, 401 13

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

    Ústí nad Orlicí, 562 18

Other trials in Czechia

France12 sites

  • HOP Ambroise Paré

    Boulogne-Billancourt, 92104

  • HOP de la Cavale Blanche

    Brest, 29609

  • HOP Gabriel-Montpied

    Clermont-Ferrand, 63003

  • HOP CHU de Grenoble

    Grenoble, 38043

  • HOP St Joseph

    Marseille, 13285

  • CLI du Pont de Chaume

    Montauban, 82000

  • HOP Arnaud de Villeneuve

    Montpellier, 34295

  • HOP Pasteur

    Nice, 06002

  • HOP Lariboisière

    Paris, 75010

  • HOP Salpêtrière, Cardio, Paris

    Paris, 75651

  • CLI Saint-Hilaire

    Rouen, 76000

  • HOP Rangueil

    Toulouse, 31403

Other trials in France

United Kingdom12 sites

  • Birmingham City Hospital

    Birmingham, B18 7QH

  • Royal Bournemouth and Christchurch Hospital

    Bournemouth, BH7 7DW

  • Royal Derby Hospital

    Derby, DE22 3NE

  • Dorset County Hospital

    Dorchester, DT1 2JY

  • Grantham District Hospital

    Grantham, NG31 8DG

  • Wycombe General Hospital

    High Wycombe, HP11 2TT

  • Glenfield Hospital

    Leicester, LE3 9QP

  • Lincoln County Hospital

    Lincoln, LN2 5QY

  • St Bartholomew's Hospital

    London, EC1A 7BE

  • Altnagelvin Area Hospital

    Londonderry, BT47 6SB

  • James Cook University Hospital

    Middlesbrough, TS4 3BW

  • Royal Stoke University Hospital

    Stoke-on-Trent, ST4 6QG

Other trials in United Kingdom

Canada11 sites

  • Calgary Heart Centre

    Calgary, Alberta, T2N 4Z6

  • Dr. R. Labonte Prof. Med. Corp

    Greater Sudbury, Ontario, P3E 3B8

  • Hamilton General Hospital

    Hamilton, Ontario, L8L 2X2

  • Royal Victoria Hospital

    Montreal, Quebec, H3A 1A1

  • Kawartha Cardiology Clinical Trials

    Peterborough, Ontario, K9J 0B2

  • CHUS Fleurimont

    Sherbrooke, Quebec, J1H 5N4

  • IUCPQ (Laval University)

    Ste-Foy, Quebec, GLV 4G5

  • Thunder Bay Regional Health Science Centre

    Thunder Bay, Ontario, P7B 6V4

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • St. Boniface General Hospital

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

Belgium10 sites

  • Aalst - HOSP Onze-Lieve-Vrouw

    Aalst, 9300

  • Bonheiden - HOSP Imelda

    Bonheiden, 2820

  • Brussels-UNIV Brugmann -Horta

    Brussels, 1020

  • Brussels - UNIV UZ Brussel

    Brussels, 1090

  • AZ Sint-Lucas - Campus Sint Lucas

    Ghent, 9000

  • Charleroi - HOSP St-Joseph

    Gilly, 6060

  • Ziekenhuis Netwerk Antwerpen (ZNA) - Campus Middelheim

    Middelheim, 2020

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

    Sint-Niklaas, 9100

  • Tienen - PRAC De Wolf, Axel

    Tienen, 3300

  • Brussels - HOSP Europe (Ste-Elisabeth)

    Uccle, 1180

Other trials in Belgium

Greece10 sites

  • University Hospital of Alexandroupolis

    Alexandroupoli, 68100

  • Hippokration Hospital, Univ Clinic of Cardiology

    Athens, 11527

  • General Hospital of Athens "Alexandra"

    Athens, 11528

  • General Hospital of Athens Konstantopoulio-Agia Olga

    Athens, 14233

  • General Hospital of Attica "Sismanoglio - Amalia Fleming"

    Athens, 15126

  • General Hospital of Chios, Department of Cardiology

    Chios, 82100

  • University General Hospital of Heraklion

    Heraklion, Crete, 71110

  • Univ. Gen. Hosp. of Ioannina

    Ioannina, 45500

  • University Hospital of Patras

    Pátrai, 26504

  • University Hospital of Thessaloniki AHEPA

    Thessaloniki, 54636

Other trials in Greece

Poland10 sites

  • Univ. Clinic Hosp, Bialystok

    Bialystok, 15276

  • 10.Military Clin.Hospital&Polyclinic

    Bydgoszcz, 85681

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

    Gdansk, 80215

  • University Clinical Center, Gdansk

    Gdansk, 80952

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

    Kielce, 25736

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

    Lublin, 20954

  • Independent Public Healthcare, Dept. of Cardiology, Pulawy

    Puławy, 24100

  • Central Hospital of Medical Academy, Warsaw

    Warsaw, 02-097

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

    Wroclaw, 54049

  • John Paul II Regional Hospital, Zamosc

    Zamość, 22400

Other trials in Poland

Argentina9 sites

  • Fundación Favaloro

    CABA, C1093AAS

  • Hospital Italiano de Buenos Aires

    CABA, C1199ABB

  • Instituto Cardiovascular de Buenos Aires

    CABA, C1428DCO

  • Consultorios Asociados de Endocrinología e Invest Clínica

    Capital Federal, C1425AGC

  • Sanatorio Allende

    Córdoba, X5000BFB

  • Instituto de Cardiología de Corrientes

    Corrientes, W3400AMZ

  • Instituto CER

    Quilmes, B1878DVB

  • Inst.Cardiovascular San Luis

    San Luis, D5702JRS

  • Investigaciones Clinicas Tucumán

    San Miguel de Tucumán, T4000ICL

Other trials in Argentina

India9 sites

  • Care Institute Of Medical Sciences

    Ahmedabad, 380060

  • Medanta- The Medicity

    Gūrgaon, 122001

  • Nizam's Institute of Medical Sciences

    Hyderabad, 500034

  • B and M Patel Cardiac Centre, Shree Krishna Hospital,

    Karamsad, 388325

  • Shri Krishna Hrudayalaya and Critical Care

    Nagpur, 440012

  • Vijan Cardiac and Critical Care Centre

    Nashik, 422005

  • Fortis Escorts Heart Institute

    New Delhi, 110025

  • Byramjee Jeejeebhoy Medical College

    Pune, 411001

  • King George's Hospital,

    Seemandhra, 530002

Other trials in India

Australia8 sites

  • Pendlebury Research

    Adamstown, New South Wales, 2289

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Heartcare Victoria

    Bundoora, Victoria, 3083

  • The Prince Charles Hospital

    Chermside, Queensland, 4032

  • The Geelong Hospital

    Geelong, Victoria, 3220

  • Gosford Hospital

    Gosford, New South Wales, 2250

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

  • Wollongong Hospital

    Wollongong, New South Wales, 2500

Other trials in Australia

Brazil8 sites

  • Hospital Santa Isabel

    Blumenau, 89010-500

  • Irmandade da Santa Casa de Misericordia de Curitiba

    Campina Grande do Sul, 83430-000

  • Instituto de Cardiologia Rio Grande do Sul

    Porto Alegre, 90620-001

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

    São José do Rio Preto, 15090-000

  • Instituto Dante Pazzanese de Cardiologia

    São Paulo, 04012-909

  • Hospital Sao Paulo - UNIFESP

    São Paulo, 04024-002

  • INCOR e Hospital das Clínicas da Universidade de São Paulo

    São Paulo, 05403-000

  • Eurolatino pesquisas Médicas Ltda

    Uberlândia, 38411-186

Other trials in Brazil

Netherlands8 sites

  • Noordwest Ziekenhuisgroep

    Alkmaar, 1815 JD

  • Catharina Ziekenhuis

    Eindhoven, 5623 EJ

  • Scheper Ziekenhuis

    Emmen, 7824 AA

  • Admiraal de Ruyter Ziekenhuis

    Goes, 4462 GA

  • UMCG

    Groningen, 9713 GZ

  • St. Antonius ziekenhuis, locatie Nieuwegein

    Nieuwegein, 3435 CM

  • Canisius-Wilhelmina ziekenhuis

    Nijmegen, 6532 SZ

  • Ziekenhuis Bernhoven Uden

    Uden, 5406 PT

Other trials in Netherlands

Sweden8 sites

  • Länssjukhuset, Gävle

    Gävle, 801 87

  • Sahlgrenska Universitetssjukhuset, Östra

    Gothenburg, 416 85

  • Länssjukhuset, Halmstad

    Halmstad, 301 85

  • Lasarettet, Helsingborg

    Helsingborg, 251 87

  • Universitetssjukhuset, Linköping

    Linköping, 581 85

  • Skånes universitetssjukhus, Lund

    Lund, 221 85

  • Skånes universitetssjukhus, Malmö

    Malmö, 205 02

  • Danderyds Sjukhus

    Stockholm, 182 88

Other trials in Sweden

Taiwan8 sites

  • Chang-Hua Christian Hospital

    Changhua, 500

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756

  • E-Da Hospital

    Kaohsiung City, 824

  • China Medical University Hospital

    Taichung, 40447

  • NCKUH

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipe Veterans General Hospital

    Taipei, 11217

  • Chang Gung Memorial Hospital(TaoYuan)

    Taoyuan, 330

Other trials in Taiwan

Hungary7 sites

  • Gottsegen Gyorgy Hungarian Instit.of Cardiology,Budapest

    Budapest, 1096

  • Semmelweis University

    Budapest, 1122

  • Milit.Hosp.-State Health Cent.

    Budapest, 1134

  • University Debrecen Hospital

    Debrecen, 4032

  • Bacs-Kiskun Megyei Onkormanyzat Hospital

    Kecskemét, 6000

  • University of Pecs, Invasive Cardiology

    Pécs, 7624

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

    Szeged, 6725

Other trials in Hungary

Portugal7 sites

  • Hospital Garcia de Orta, EPE

    Almada, 2805-267

  • CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

    Coimbra, 3000-075

  • Centro Hosp. de Leiria-Pombal

    Leiria, 2410-197

  • CHLC, EPE - Hospital de Santa Marta

    Lisbon, 1169-024

  • CHLO, EPE - Hospital de Santa Cruz

    Lisbon, 1495-005

  • CHLN, EPE - Hospital de Santa Maria

    Lisbon, 1649-035

  • CHUC,EPE - Hospital Geral dos Covões

    S. Martinho Do Bispo,Coimbra, 3041-801

Other trials in Portugal

Bulgaria6 sites

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

    Burgas, 8127

  • SHAT in Cardiology EAD, Pleven

    Pleven, 5800

  • MHAT"Sv.Georgi",Cardi.Clin.

    Plovdiv, 4001

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

    Sandanski, 2800

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

    Sofia, 1407

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

    Yambol, 8600

Other trials in Bulgaria

Colombia6 sites

  • Fundación Clínica Abood Shaio

    Bogotá

  • Fundación Santa Fe de Bogotá

    Bogotá

  • Centro Médico Imbanaco de Cali S.A.

    Cali, 760042

  • Fundación Valle de Lili

    Cali

  • Fundación Cardiovascular de Colombia

    Floridablanca, 680004

  • Hospital Pablo Tobón Uribe

    Medellín, 050034

Other trials in Colombia

Israel6 sites

  • Hillel Yaffe Medical Center, Hadera

    Hadera, 38100

  • Rambam Medical Center

    Haifa, 31096

  • Wolfson Medical Center

    Holon, 58100

  • Shaare Zedek Medical Center, Jerusalem 91031

    Jerusalem, 91031

  • West.Galilee Med.Cent.Naharia

    Nahariya, 22100

  • Rabin Medical Center Beilinson

    Petah Tikva, 49100

Other trials in Israel

Croatia5 sites

  • Clincal Hospital Centre Rijeka

    Rijeka, 51000

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

    Zagreb, 10 000

  • Clinical Hospital Sstre Milosrdnice, Cardiology Dept, Zagreb

    Zagreb, 10000

  • University hospital center Zagreb

    Zagreb, 10000

  • University Hospital Dubrava

    Zagreb, 10000

Other trials in Croatia

Norway5 sites

  • Sørlandet sykehus HF, Avd. Arendal

    Arendal, N-4838

  • Oslo Universitetssykehus HF, Ullevål sykehus

    Oslo, N-0407

  • Oslo Universitetssykehus HF, Rikshospitalet

    Oslo, N-0424

  • Stavanger Helseforskning

    Stavanger, N-4068

  • Universitetssykehuset Nord-Norge, Tromsø

    Tromsø, N-9038

Other trials in Norway

Chile4 sites

  • Hospital San Juan de Dios

    Santiago, 8350488

  • Centro de Estudios Clinicos Barros Luco

    Santiago, 8910131

  • Hospital Las Higueras

    Talcahuano, 4270918

  • CECMI Ltda

    Temuco, 4813299

Other trials in Chile

Finland4 sites

  • HYKS, Kardiologian klinikka, Sydän- ja keuhkokeskus

    Helsinki, 00290

  • StudyCor Oy

    Jyväskylä, 42620

  • Keski-Pohjanmaan keskussairaala, Kardiologian pkl, Kokkola

    Kokkola, 67200

  • TYKS

    Turku, 20520

Other trials in Finland

Hong Kong4 sites

  • Prince of Wales Hosp, Dept of Med & Therapeutics

    Hong Kong

  • Princess Margaret Hospital

    Hong Kong

  • Queen Elizabeth Hospital

    Hong Kong

  • Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

Ireland4 sites

  • Mater Misericordiae University Hospital

    Dublin, DUBLIN 7

  • St James's Hospital

    Dublin, DUBLIN 8

  • Beaumont Hospital

    Dublin, DUBLIN 9

  • University Hospital Galway

    Galway, GALWAY

Other trials in Ireland

Mexico4 sites

  • Hospital Cardiologica Aguascalientes

    Aguascalientes, 20230

  • Instituto Nacional de Cardiologia Ignacio Chavez

    Mexico City, 14080

  • H. Central Dr Ignacio M. P.

    San Luis Potosí City, 78240

  • Centro Especializado en Terapia Endovascular (CETEN)

    Zapopan, Jalisco, 45040

Other trials in Mexico

Slovakia4 sites

  • Slov.Ins.Crdi.Dise.,Cor.C.U.

    Banská Bystrica, 97401

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

    Bratislava, 83348

  • East Slovak Inst.Cardi.Disea.

    Košice, 04011

  • Kardiocentrum Nitra,Internal Medicine Dept, Nitra

    Nitra, 94901

Other trials in Slovakia

Slovenia4 sites

  • General Hospital Celje

    Celje, 3000

  • General Hospital Izola, Cardiology Department

    Izola, 6310

  • University Medical Center Ljubljana

    Ljubljana, 1000

  • Univ. Medical Center Maribor

    Maribor, 2000

Other trials in Slovenia

Thailand4 sites

  • Siriraj Hospital

    Bangkok, 10170

  • Ramathibodi Hospital

    Bangkok, 10400

  • Maharaj Nakorn Chiang Mai Hospital

    Chiang Mai, 50200

  • Srinagarind Hospital

    Khon Kaen, 40002

Other trials in Thailand

Austria3 sites

  • Order Hospital Elisabethinen Linz

    Linz, 4020

  • LKH Salzburg, Univ. Clinic

    Salzburg, 5020

  • Wilhelminenspital

    Vienna, 1160

Other trials in Austria

Singapore2 sites

  • National University Hospital

    Singapore, 119228

  • National Heart Center

    Singapore, 169609

Other trials in Singapore

Denmark1 site

  • Aarhus Universitetshospital

    Århus N, 8200

Other trials in Denmark

New Zealand1 site

  • Waikato Hospital

    Hamilton, 3240

Other trials in New Zealand

About this study

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

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.

Being tested
Dabigatran Etexilate 110mg, Warfarin 3mg, Aspirin, Dabigatran Etexilate 150mg, Clopidogrel or Ticagrelor
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dabigatran Etexilate 110mgDrug

    Active treatment

  • Warfarin 3mgDrug

    Active comparator

  • AspirinDrug

    Active comparator

  • Dabigatran Etexilate 150mgDrug

    Active treatment

  • Clopidogrel or TicagrelorDrug

    Active comparator

  • Clopidogrel or TicagrelorDrug

    Active comparator

  • Warfarin 5mgDrug

    Active comparator

  • Clopidogrel or TicagrelorDrug

    Active comparator

  • Warfarin 1mgDrug

    Active comparator

Study groups in NCT02164864
Study groupRoleWhat they receive
Dabigatran Etexilate 110mgExperimentalPatient to receive Dabigatran Etexilate 110mg twice a day (BID)
Receives: Drug: Dabigatran Etexilate 110mg; Drug: Clopidogrel or Ticagrelor
Dabigatran Etexilate 150mgExperimentalPatient to receive Dabigatran Etexilate 150mg twice a day (BID)
Receives: Drug: Dabigatran Etexilate 150mg; Drug: Clopidogrel or Ticagrelor
WarfarinActive comparatorWarfarin doses to maintain INR
Receives: Drug: Warfarin 3mg; Drug: Aspirin; Drug: Clopidogrel or Ticagrelor; Drug: Warfarin 5mg; Drug: Warfarin 1mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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'.

    Measured: up to 30 months

Secondary outcomes (12)

  1. Time to Adjudicated Undetermined Cause of Death

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

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

    Measured: up to 30 months

  2. Time to Adjudicated Non-CV

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

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

    Measured: up to 30 months

  3. Time to Adjudicated CV

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

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

    Measured: up to 30 months

  4. Time to Adjudicated All Cause Death

    Time to event analysis of patients with adjudicated all cause death. The number of observed patients with adjudicated all cause death was reported. All cause death is defined as the death from any cause included CV death, non-CV death, and undetermined cause of death.

    Measured: up to 30 months

  5. Time to First Adjudicated MI

    Time to event analysis of patients with first adjudicated Myocardial Infarction (MI). The number of observed patients with adjudicated MI was reported

    Measured: up to 30 months

  6. Time to First Adjudicated Stroke

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

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

    Measured: up to 30 months

  7. Time to First Adjudicated SE

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

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

    Measured: up to 30 months

  8. Time to First Adjudicated ST

    Time to event analysis of patients with first adjudicated Stent Thrombosis (ST). The number of observed patients with adjudicated ST was reported.

    Measured: up to 30 months

  9. Time to Composite Endpoint of Death + MI + Stroke

    Time to event analysis of patients with the composite endpoint of death + myocardial infarction (MI) + stroke. The number of observed patients with the composite endpoint of death + myocardial infarction (MI) + stroke was reported.

    Measured: up to 30 months

  10. Time to Composite Endpoint of Death or First Thrombotic Event

    Time to event analysis of patients with composite endpoint of death or first thrombotic event (all death, myocardial infarction (MI), stroke/systemic embolism (SE)). The number of observed patients with composite endpoint of death or thrombotic event (all death, MI, stroke/SE).

    Measured: up to 30 months

  11. Time to First Adjudicated Unplanned Revascularisation by PCI/CABG

    Time to event analysis of patients with adjudicated unplanned revascularisation by Percutaneous Coronary Intervention (PCI)/Coronary Artery Bypass Graft (CABG). The number of observed patients with adjudicated unplanned revascularisation by PCI/CABG was reported.

    Measured: up to 30 months

  12. Time to Death or First Thrombotic Event or Unplanned Revascularisation by PCI/CABG

    Time to event analysis of patients with death or thrombotic event (all death, myocardial infarction, stroke/systemic embolism) or unplanned revascularisation by Percutaneous Coronary Intervention/Coronary Artery Bypass Graft. The number of observed patients with death or first thrombotic event or unplanned revascularisation by PCI/CABG was reported.

    Measured: up to 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2014 (estimated)
  2. Study start22 Jul 2014
  3. Primary completion5 Jun 2017
  4. Study completion5 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,725 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02164864
Sponsor's protocol ID
1160.186
Other IDs
2013-003201-26
Status last verified
Jul 2018
First submitted
13 Jun 2014
Last updated
31 Jul 2018

Publications

  • 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.

    PubMed 32562206

  • 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.

    PubMed 32389658

  • 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.

    PubMed 32252548

  • 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.

    PubMed 31439336

  • 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.

    PubMed 30015064

  • 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.

    PubMed 28844193

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dabigatran Etexilate 110mg, Warfarin 3mg and Aspirin in people with Atrial Fibrillation and Percutaneous Coronary Intervention, run by Boehringer Ingelheim at 421 sites in 41 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 421 sites in Germany, United States, Japan, Turkey (Türkiye), Italy and 36 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to First Adjudicated ISTH MBE or CRNMBE (time frame: up to 30 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02164864, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2018.

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