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Reversal of Dabigatran Anticoagulant Effect With Idarucizumab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02104947
Recruitment Status : Completed
First Posted : April 7, 2014
Results First Posted : August 18, 2017
Last Update Posted : January 5, 2018
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hemorrhage Drug: idarucizumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 503 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 6, 2014
Actual Primary Completion Date : July 25, 2016
Actual Study Completion Date : October 20, 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: idarucizumab
idarucizumab Only 1 treatment, no placebo or comparator
Drug: idarucizumab

Primary Outcome Measures :
  1. Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of dTT or ECT [ Time Frame: from the end of the first infusion up to 4 hours after the last infusion on Day 1 ]

    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.

Secondary Outcome Measures :
  1. Reversal of aPTT and TT From Central Laboratory [ Time Frame: from the end of the first infusion up to 4 hours after the last infusion on Day 1 ]

    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.

  2. Duration of Reversal [ Time Frame: from the first infusion up to 24 hours after the last infusion on Day 1 ]
    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.

  3. Occurrence of Major/Life-threatening/Fatal Bleeding (for Group B Only) Intraoperatively [ Time Frame: within 24 hours of surgery ]
    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.

  4. Time to Cessation of Bleeding (for Group A Only) [ Time Frame: from the first infusion up to 24 hours after the last infusion on Day 1 ]
    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.

  5. Cmin,1 of Unbound Sum (Free) Dabigatran [ Time Frame: Since the end of first vial of idarucizumab up to 4 hours after the completion of second vial ]
    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.

  6. 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 [ Time Frame: after the first vial of idarucizumab and before the start of second vial on Day1 ]

    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02104947

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

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Responsible Party: Boehringer Ingelheim Identifier: NCT02104947    
Other Study ID Numbers: 1321.3
2013-004813-41 ( EudraCT Number )
First Posted: April 7, 2014    Key Record Dates
Results First Posted: August 18, 2017
Last Update Posted: January 5, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Pathologic Processes