Reversal of Dabigatran Anticoagulant Effect With Idarucizumab

A Phase III Case Series Clinical Study of the Reversal of the Anticoagulant Effects of Dabigatran by Intravenous Administration of 5.0g Idarucizumab (BI 655075) in Patients Treated Wtih Dabigatran Etexilate Who Have Uncontrolled Bleeding or Require Emergency Surgery or Procedures.RE-VERSE AD (A Study of the RE-VERSal Effects of Idarucizumab on Active Dabigatran) Trial

Evaluate the reversal of the anticoagulant effects of dabigatran by IV administration of 5.0g idarucizumab in patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures.

Study Overview

• Status: Completed
• Conditions: Hemorrhage
• Intervention / Treatment: Drug: idarucizumab

• Study Type: Interventional
• Enrollment (Actual): 503
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Tucumán, Argentina, ZC4000
    • Centro Privado de Cardiología
• Australia
  • New South Wales
    • Concord, New South Wales, Australia, 2139
      • Concord Repatriation General Hospital
    • Kogarah, New South Wales, Australia, 2217
      • St George Hospital
    • St Leonards, New South Wales, Australia, 2065
      • Royal North Shore Hospital
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital-Clinical Haematology Dept
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Flinders Medical Centre
  • Victoria
    • Fitzroy, Victoria, Australia, 3065
      • St. Vincents Hospital (MEL)
• Austria
  • Linz, Austria, 4020
    • Kepler Univ. Klinikum Linz
  • Linz, Austria, 4010
    • KH der Barmherzigen Schwestern Linz
  • Wien, Austria, 1090
    • AKH - Medical University of Vienna
  • Wien, Austria, 1160
    • Wilhelminenspital
• Belgium
  • Aalst, Belgium, 9300
    • Aalst - HOSP Onze-Lieve-Vrouw
  • Brussel, Belgium, 1090
    • Brussels - UNIV UZ Brussel
  • Brussels, Belgium, 1000
    • Brussels - UNIV St-Pierre
  • Bruxelles, Belgium, 1200
    • Brussels - UNIV St-Luc
  • Genk, Belgium, 3600
    • Genk - HOSP ZOL (St-Jan)
  • Leuven, Belgium, 3000
    • UZ Leuven
• Brazil
  • Caxias do Sul, Brazil, 95010-005
    • Hospital Nossa Senhora de Pompeia
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V1Y 1S1
      • St. Paul's Hospital
  • Migration Data
    • Montreal, Migration Data, Canada, H3T 1E2
      • Jewish General Hospital
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton General Hospital
    • Hamilton, Ontario, Canada, L8V 5C2
      • Juravinski Hospital
• Colombia
  • Cali, Colombia, 760032
    • Fundacion Valle del Lili
  • Cali, Colombia, 760042
    • Centro Medico Imbanaco de Cali S.A.
  • Floridablanca, Colombia
    • Fundacion Cardiovascular de Colombia
  • Medellin, Colombia, 50034
    • Hospital Pablo Tobon Uribe
• Czechia
  • Brno, Czechia, 625 00
    • University Hospital Brno
  • Ceske Budejovice, Czechia, 370 01
    • Hospital,Neurology Dept,Ceske Budejovice
  • Hradec Kralove, Czechia, 500 05
    • Hospital Hradec Kralove
  • Liberec, Czechia, 460 63
    • Regional Hospital Liberec
  • Praha, Czechia, 100 34
    • Univ. Hospital Kralovske Vinohrady
  • Praha 5, Czechia, 150 06
    • University Hospital Motol
• Denmark
  • Aarhus C, Denmark, 8000
    • Aarhus Universitetshospital
• Finland
  • Helsinki, Finland, 00290
    • HUS, Kirurginen päivystysosasto P1P, Meilahti, Helsinki
  • Jyväskylä, Finland, 40620
    • Keski-Suomen Keskussairaala
  • Oulu, Finland, 90220
    • Oulun yliopistollinen keskussairaala
  • Tampere, Finland, 33521
    • TAYS, Acuta, Tampere
  • Turku, Finland, 20521
    • TYKS, Akuutti sisätautihoito ASIS, Turku
• France
  • Chambray les tours, France, 37170
    • HOP Trousseau
  • Dijon, France, 21079
    • HOP Bocage
  • Le Chesnay, France, 78150
    • HOP André Mignot
  • Lille cedex, France, 59037
    • HOP Lille, SAMU 59, Lille
  • Limoges, France, 87042
    • HOP Dupuytren
  • Lyon, France, 69003
    • HOP Herriot
  • Montpellier cedex, France, 34295
    • HOP Lapeyronie
  • Pessac, France, 33604
    • HOP Haut-Lévêque
  • Pierre Benite, France, 69495
    • HOP Lyon Sud
  • Saint-Priest-en-Jarez, France, 42270
    • HOP Nord
  • Toulon, France, 83041
    • HOP Sainte Anne, Urgence, Toulon
• Germany
  • Berlin, Germany, 12351
    • Vivantes Netzwerk für Gesundheit GmbH
  • Greifswald, Germany, 17475
    • Universitätsmedizin Greifswald
  • Mainz, Germany, 55131
    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
• Hong Kong
  • Hong Kong, Hong Kong
    • Prince of Wales Hospital
  • Hong Kong, Hong Kong
    • Pamela Youde Nethersole Eastern Hospital
  • Hong Kong, Hong Kong
    • Prince of Wales Hosp, Dept of Med & Therapeutics
• India
  • Kolkatta, India, 700027
    • B.M. Birla Heart research Centre
  • New Delhi, India, 110025
    • Fortis Escorts Heart Institute
• Ireland
  • Dublin, Ireland, Dublin 8
    • St James's Hospital
  • Wilton, Ireland
    • Cork University Hospital
• Israel
  • Haifa, Israel, 3109601
    • Rambam Medical Center
  • Kfar Saba, Israel, 44281
    • Meir Medical Center
  • Ramat Gan, Israel, 52621
    • The Chaim Sheba Medical Center Tel HaShomer
  • Tel Aviv, Israel, 64239
    • Sourasky Medical Center
• Italy
  • Firenze, Italy, 50134
    • Azienda Ospedaliera Careggi
  • Perugia, Italy, 06132
    • Ospedale S.Maria della Misericordia, AO di Perugia
  • Reggio Emilia, Italy, 42123
    • Azienda Unita Sanitaria Locale di Reggio Emilia
  • Roma, Italy, 00168
    • Policlinico Gemelli
  • Roma, Italy, 00184
    • Az. Osp. S.Giovanni-Addolorata
• Japan
  • Aichi, Nagoya, Japan, 466-8650
    • Japanese Red Cross Nagoya Daini Hospital
  • Ehime, Matsuyama, Japan, 790-0024
    • Ehime Prefectural Central Hospital
  • Fukuoka, Kasuga, Japan, 816-0864
    • Fukuoka Tokushukai Medical Center
  • Gifu, Ogaki, Japan, 503-8502
    • Ogaki Municipal Hospital
  • Gunma, Takasaki, Japan, 370-0829
    • National Hospital Organization Takasaki General Medical Center
  • Hyogo, Nishinomiya, Japan, 663-8501
    • Hyogo College of Medicine Hospital
  • Kagoshima, Kagoshima, Japan, 892-0853
    • National Hospital Organization Kagoshima Medical Center
  • Kanagawa, Kamakura, Japan, 247-8533
    • Shonan Kamakura General Hospital
  • Osaka, Suita, Japan, 565-8565
    • National Cerebral and Cardiovascular Center
  • Tokyo, Bunkyo-Ku, Japan, 113-8603
    • Nippon Medical School Hospital
  • Tokyo, Tachikawa, Japan, 190-0014
    • National Hospital Organization Disaster Medical Center
  • Yamagata, Yamagata, Japan, 990-8533
    • Yamagata City Hospital Saiseikan
• Korea, Republic of
  • Seongnam, Korea, Republic of, 463-707
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 137-701
    • The Catholic University of Korea, Seoul St.Mary's Hospital
• Mexico
  • Aguascalientes, Mexico, 20297
    • Hospital Cardiologica Aguascalientes
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Academisch Medisch Centrum (AMC)
  • Amsterdam, Netherlands, 1091 AC
    • OLVG, locatie Oosterpark
  • Groningen, Netherlands, 9728 NT
    • Martini Ziekenhuis
  • Maastricht, Netherlands, 6229 ER
    • Maastricht Universitair Medisch Centrum
  • Nijmegen, Netherlands, 6525 GA
    • Radboud Universitair Medisch Centrum
  • Rotterdam, Netherlands, 3015 CE
    • Erasmus Medisch Centrum
• New Zealand
  • Christchurch, New Zealand, 8011
    • Christchurch Hospital
  • Grafton / Auckland, New Zealand, 1023
    • Auckland City Hospital
  • Hamilton, New Zealand, 3240
    • Waikato Hospital
  • Otahuhu South Auckland, New Zealand, 2025
    • Middlemore Hospital
  • Takapuna Auckland, New Zealand, 0620
    • North Shore Hospital, Takapuna
• Norway
  • Bergen, Norway, N-5021
    • Haukeland Universitetssykehus
  • Drammen, Norway, N-3004
    • Vestre Viken HF, Drammen Sykehus
  • Grålum, Norway, N-1714
    • Sykehuset Østfold Kalnes
  • Oslo, Norway, N-0424
    • Oslo Universitetssykehus HF, Ullevål sykehus
  • Tromsø, Norway, N-9038
    • Universitetssykehuset Nord-Norge, Tromsø
• Poland
  • Bialystok, Poland, 15276
    • Univ. Clinic Hosp, Bialystok
  • Gdansk, Poland, 80952
    • University Clinical Center, Gdansk
  • Gdynia, Poland, 81348
    • Saint Wincenty a Paulo Hosp., Cardiology Dept., Gdynia
  • Kielce, Poland, 25736
    • Reg.Hosp Kielce,Swietokrzyskie,1.Clinic of Cardiology,Kielce
  • Krakow, Poland, 31202
    • The John Paul II Hosp.,Dept.of Coronary Heart Disease,Krakow
  • Lublin, Poland, 20718
    • Stefan Kardynal Wyszynski Reg.Hosp,Cardiol&IntensUnit,Lublin
  • Pulawy, Poland, 24100
    • Independent Public Healthcare, Dept. of Cardiology, Pulawy
  • Warszawa, Poland, 02507
    • Central Hosp.Minis.Interior,Dep.Noninvasive Cardiol,Warszawa
• Portugal
  • Covilhã, Portugal, 6200-251
    • Centro Hospitalar da Cova da Beira Hospital Pêro da Covilhã
  • Lisboa, Portugal, 1495-005
    • CHLO, EPE - Hospital S. Francisco Xavier
  • Porto, Portugal, 4202-451
    • Centro Hospitalar São João,EPE
  • Porto, Portugal, 4099-001
    • Centro Hospitalar do Porto, EPE
• Russian Federation
  • Saint Petersburg, Russian Federation, 199 106
    • City Pokrovskiy Hospital, Cardiology Dept., Saint Petersburg
  • St. Petersburg, Russian Federation, 194175
    • Military Medical Academy n.a. S. M. Kirov, St. Petersburg
• Singapore
  • Singapore, Singapore, 169608
    • Singapore General Hospital
  • Singapore, Singapore, 119074
    • National University Hospital
  • Singapore, Singapore, 529889
    • Changi General Hospital
• South Africa
  • Sandton, South Africa, 2021
    • Dr. D. Adler
  • Somerset West, South Africa, 7130
    • Dr. Engelbrecht
• Spain
  • Alicante, Spain, 03010
    • Hospital General Universitario de Alicante
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona
  • Barcelona, Spain, 08035
    • Hospital Vall d'Hebron
  • Barcelona, Spain, 08907
    • Hospital de Bellvitge
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28034
    • Hospital Ramon y Cajal
  • Madrid, Spain, 28046
    • Hospital La Paz
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon
  • Malaga, Spain, 29010
    • Hospital Regional Universitario de Málaga
  • Santander, Spain, 39008
    • Hospital Universitario Marques de Valdecilla
  • Valencia, Spain, 46010
    • Hospital Clinico de Valencia
  • Valencia, Spain, 46009
    • Hospital Politècnic La Fe
  • Vigo (Pontevedra), Spain, 36312
    • Hospital Álvaro Cunqueiro
  • Zaragoza, Spain, 50009
    • Hospital Clinico Universitario Lozano Blesa
• Sweden
  • Göteborg, Sweden, 413 45
    • Sahlgrenska US, Göteborg
  • Lund, Sweden, 221 85
    • Skanes universitetssjukhus
  • Uppsala, Sweden, 751 85
    • Akademiska Sjukhuset
• Taiwan
  • Kaohsiung, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • New Taipei City, Taiwan, 220
    • Far Eastern Memorial Hospital
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11217
    • Taipe Veterans General Hospital
• United Kingdom
  • Basingstoke, United Kingdom, RG24 9NA
    • North Hampshire Hospital
  • Liverpool, United Kingdom, L7 8XP
    • Royal Liverpool University Hospital
  • London, United Kingdom, SW17 0QT
    • St George's Hospital
  • London, United Kingdom, E1 1ES
    • Royal London Hospital
  • Oxford, United Kingdom, OX3 9DU
    • Emergency Department, John Radcliffe Hospital, Oxford
  • Southampton, United Kingdom, SO16 6YD
    • Southampton General Hospital
  • Taunton, United Kingdom, TA1 5DA
    • Musgrove Park Hospital
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Baptist Health Center for Clinical Research
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20010-2975
      • MedStar Washington Hospital Center
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida College of Medicine
    • Jacksonville, Florida, United States, 32207
      • Baptist Medical Center
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Cancer Center
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
    • Tampa, Florida, United States, 33607
      • St. Joseph's Hospital
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Peoria, Illinois, United States, 61637
      • OSF Saint Francis Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • IU Health Methodist Hospital
    • Munster, Indiana, United States, 46321
      • Community Hospital
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Our Lady of the Lake Regional Medical Center
  • Massachusetts
    • Newton, Massachusetts, United States, 02462
      • Newton-Wellesley Hospital
  • Michigan
    • Grand Blanc, Michigan, United States, 48439
      • Genesys Regional Medical Center
    • Jackson, Michigan, United States, 49201
      • Henry Ford Allegiance Health
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Mercy Hospital St. Louis
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati
    • Dayton, Ohio, United States, 45409
      • Miami Valley Hospital
    • Youngstown, Ohio, United States, 44501
      • St. Elizabeth Youngstown Hospital
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • St. John Health System Inc
  • Pennsylvania
    • Langhorne, Pennsylvania, United States, 19047
      • St. Mary Medical Center
    • Wynnewood, Pennsylvania, United States, 19096
      • Lankenau Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Texas Health Research and Education Institute
    • Houston, Texas, United States, 77030
      • Memorial Hermann Hospital - Texas Medical Center
  • Virginia
    • Harrisonburg, Virginia, United States, 22801
      • Sentara RMH Medical Center
    • Richmond, Virginia, United States, 23298-0401
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Group A (Bleeding patients)

  • Overt bleeding judged by the physician to require a reversal agent
  • Currently taking dabigatran etexilate
  • At least 18 years of age
  • Written informed consent

• Group B (Patients who are taking dabigatran who may not be bleeding, but do require an emergency surgery or procedure for a condition other than bleeding

  • Condition requiring emergency surgery or invasive procedure where adequate hemostasis is required. Emergency is defined as within the following 8 hours.
  • Current treatment with dabigatran
  • At least 18 years of age
  • Written Informed consent.

Exclusion criteria:

• Group A (Bleeding Patients)

  • Patients with minor bleeds (epistaxis, hematuria) who can be managed with standard supportive care.
  • Patients with no clinical signs of bleeding
  • Contraindications to study medication including known hypersensitivity to the drug or its excipients.

• Group B (Patients who require emergency surgery or procedure)

  • A surgery or procedure which is elective or where the risk of uncontrolled or unmanageable bleeding is low.
  • Contraindications to study medication including known hypersensitivity to the drug or its excipients (subjects with hereditary fructose intolerance may react to sorbitol).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: idarucizumab; idarucizumab Only 1 treatment, no placebo or comparator	Drug: idarucizumab; idarucizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of dTT or ECT	Maximum reversal of anticoagulant effect of dabigatran based on central laboratory determination of diluted thrombin time (dTT) or ecarin clotting time (ECT), at any time point from the end of the first infusion up to 4 hours after the last infusion. Reversal is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% ULN (evaluable patients). Reversal is calculated as 100* (pre-dose value minus post dose value)/(pre-dose value minus 100% x ULN); if calculated reversal is > 100, it was set to 100.	from the end of the first infusion up to 4 hours after the last infusion on Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reversal of aPTT and TT From Central Laboratory	Reversal of anticoagulation as measured by Activated Partial Thromboplastin Time (aPTT) and Thrombin time (TT), at any time point since the end of first infusion up to 4 hours after the completion of the last infusion. Reversal is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% ULN (evaluable patients). Reversal is calculated as 100* (pre-dose value minus post dose value)/(pre-dose value minus 100% x ULN); if calculated reversal is > 100, it was set to 100.	from the end of the first infusion up to 4 hours after the last infusion on Day 1
Duration of Reversal	Duration of reversal, defined as the time period a patient remained completely reversed based on dTT or ECT, up to 24 hours or re-starting the treatment of dabigatran.	from the first infusion up to 24 hours after the last infusion on Day 1
Occurrence of Major/Life-threatening/Fatal Bleeding (for Group B Only) Intraoperatively	Occurrence of major/life-threatening/fatal bleeding (for group B only) intraoperatively and up to 24 hours post-surgery were classified according to major or life-threatening bleeding (ISTH [International Society for Thrombosis and Hemostasis] definition). 95% Confidence Interval (CI) is from Clopper-Pearson method.	within 24 hours of surgery
Time to Cessation of Bleeding (for Group A Only)	Time to cessation of bleeding (for Group A only) since first infusion up to 24 hours after the completion of second infusion; bleeding status was to be categorized before and at several time points after treatment.	from the first infusion up to 24 hours after the last infusion on Day 1
Cmin,1 of Unbound Sum (Free) Dabigatran	Cmin,1 (Minimum concentrations at any time point since the end of first vial of idarucizumab up to 4 hours after the completion of second vial) of unbound sum (free) dabigatran, provided that two vials given not more than 15 min apart in group A and B.	Since the end of first vial of idarucizumab up to 4 hours after the completion of second vial
Reversal of Anticoagulation as Measured by Diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT) After the First Vial of Idarucizumab and Before the Start of Second Vial	Reversal of anticoagulation as measured by diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT) after the first vial of idarucizumab and before the start of second vial. Reversal is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% ULN (evaluable patients). Reversal is calculated as 100*(pre-dose value minus post dose value)/(pre-dose value minus 100% x ULN); if calculated reversal is > 100, it was set to 100.	after the first vial of idarucizumab and before the start of second vial on Day1

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

General Publications

• Eikelboom JW, van Ryn J, Reilly P, Hylek EM, Elsaesser A, Glund S, Pollack CV, Weitz JI. Dabigatran Reversal With Idarucizumab in Patients With Renal Impairment. J Am Coll Cardiol. 2019 Oct 8;74(14):1760-1768. doi: 10.1016/j.jacc.2019.07.070.
• Glund S, Coble K, Gansser D, Stangier J, Hoermann K, Pollack CV, Reilly P. Pharmacokinetics of idarucizumab and its target dabigatran in patients requiring urgent reversal of the anticoagulant effect of dabigatran. J Thromb Haemost. 2019 Aug;17(8):1319-1328. doi: 10.1111/jth.14476. Epub 2019 Jun 18.
• Van der Wall SJ, Lopes RD, Aisenberg J, Reilly P, van Ryn J, Glund S, Elsaesser A, Klok FA, Pollack CV Jr, Huisman MV. Idarucizumab for Dabigatran Reversal in the Management of Patients With Gastrointestinal Bleeding. Circulation. 2019 Feb 5;139(6):748-756. doi: 10.1161/CIRCULATIONAHA.118.036710. Erratum In: Circulation. 2019 Feb 5;139(6):e36.
• Pollack CV Jr, Reilly PA, van Ryn J, Eikelboom JW, Glund S, Bernstein RA, Dubiel R, Huisman MV, Hylek EM, Kam CW, Kamphuisen PW, Kreuzer J, Levy JH, Royle G, Sellke FW, Stangier J, Steiner T, Verhamme P, Wang B, Young L, Weitz JI. Idarucizumab for Dabigatran Reversal - Full Cohort Analysis. N Engl J Med. 2017 Aug 3;377(5):431-441. doi: 10.1056/NEJMoa1707278. Epub 2017 Jul 11.
• Pollack CV Jr, Reilly PA, Eikelboom J, Glund S, Verhamme P, Bernstein RA, Dubiel R, Huisman MV, Hylek EM, Kamphuisen PW, Kreuzer J, Levy JH, Sellke FW, Stangier J, Steiner T, Wang B, Kam CW, Weitz JI. Idarucizumab for Dabigatran Reversal. N Engl J Med. 2015 Aug 6;373(6):511-20. doi: 10.1056/NEJMoa1502000. Epub 2015 Jun 22.
• Pollack CV Jr, Reilly PA, Bernstein R, Dubiel R, Eikelboom J, Glund S, Huisman MV, Hylek E, Kam CW, Kamphuisen PW, Kreuzer J, Levy JH, Sellke F, Stangier J, Steiner T, Wang B, Weitz JI. Design and rationale for RE-VERSE AD: A phase 3 study of idarucizumab, a specific reversal agent for dabigatran. Thromb Haemost. 2015 Jul;114(1):198-205. doi: 10.1160/TH15-03-0192. Epub 2015 May 28.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2014
• Primary Completion (Actual): July 25, 2016
• Study Completion (Actual): October 20, 2016

Study Registration Dates

• First Submitted: April 2, 2014
• First Submitted That Met QC Criteria: April 2, 2014
• First Posted (Estimate): April 7, 2014

Study Record Updates

• Last Update Posted (Actual): January 5, 2018
• Last Update Submitted That Met QC Criteria: January 3, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: 1321.3; 2013-004813-41 (EudraCT Number)