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HemorrhagePhase 3NCT02104947

Reversal of Dabigatran Anticoagulant Effect With Idarucizumab

A Phase 3 study testing idarucizumab in people with Hemorrhage, run by Boehringer Ingelheim at 176 sites in 33 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

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hemorrhage
What is being tested?
idarucizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
503 participants
Where
176 sitesin 33 countries
Study dates
6 May 2014to 20 Oct 2016
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

  • 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
Show all 10Show fewer
  • 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.

Who cannot join

  • 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).

Trial locations and contacts

176 sites in 33 countries.

176 sites in 33 countries

United States30 sites

  • Our Lady of the Lake Regional Medical Center

    Baton Rouge, Louisiana, 70808

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Cincinnati

    Cincinnati, Ohio, 45219

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Texas Health Research and Education Institute

    Fort Worth, Texas, 76104

  • University of Florida College of Medicine

    Gainesville, Florida, 32610

  • Genesys Regional Medical Center

    Grand Blanc, Michigan, 48439

  • Sentara RMH Medical Center

    Harrisonburg, Virginia, 22801

  • Memorial Hermann Hospital - Texas Medical Center

    Houston, Texas, 77030

  • IU Health Methodist Hospital

    Indianapolis, Indiana, 46202

  • Henry Ford Allegiance Health

    Jackson, Michigan, 49201

  • Baptist Medical Center

    Jacksonville, Florida, 32207

  • Mayo Clinic Cancer Center

    Jacksonville, Florida, 32224

  • St. Mary Medical Center

    Langhorne, Pennsylvania, 19047

  • Baptist Health Center for Clinical Research

    Little Rock, Arkansas, 72205

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Community Hospital

    Munster, Indiana, 46321

  • Newton-Wellesley Hospital

    Newton, Massachusetts, 02462

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Virginia Commonwealth University

    Richmond, Virginia, 23298-0401

  • Mercy Hospital St. Louis

    St Louis, Missouri, 63141

  • Tampa General Hospital

    Tampa, Florida, 33606

  • St. Joseph's Hospital

    Tampa, Florida, 33607

  • St. John Health System Inc

    Tulsa, Oklahoma, 74104

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010-2975

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096

  • St. Elizabeth Youngstown Hospital

    Youngstown, Ohio, 44501

Other trials in United States

Spain14 sites

  • Hospital General Universitario de Alicante

    Alicante, 03010

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital Clínic de Barcelona

    Barcelona, 08036

  • Hospital de Bellvitge

    Barcelona, 08907

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital Ramón y Cajal

    Madrid, 28034

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Hospital La Paz

    Madrid, 28046

  • Hospital Regional Universitario de Málaga

    Málaga, 29010

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008

  • Hospital Politècnic La Fe

    Valencia, 46009

  • Hospital Clínico de Valencia

    Valencia, 46010

  • Hospital Álvaro Cunqueiro

    Vigo (Pontevedra), 36312

  • Hospital Clínico Universitario Lozano Blesa

    Zaragoza, 50009

Other trials in Spain

Japan12 sites

  • Japanese Red Cross Nagoya Daini Hospital

    Aichi, Nagoya, 466-8650

  • Ehime Prefectural Central Hospital

    Ehime, Matsuyama, 790-0024

  • Fukuoka Tokushukai Medical Center

    Fukuoka, Kasuga, 816-0864

  • Ogaki Municipal Hospital

    Gifu, Ogaki, 503-8502

  • National Hospital Organization Takasaki General Medical Center

    Gunma, Takasaki, 370-0829

  • Hyogo College of Medicine Hospital

    Hyogo, Nishinomiya, 663-8501

  • National Hospital Organization Kagoshima Medical Center

    Kagoshima, Kagoshima, 892-0853

  • Shonan Kamakura General Hospital

    Kanagawa, Kamakura, 247-8533

  • National Cerebral and Cardiovascular Center

    Osaka, Suita, 565-8565

  • Nippon Medical School Hospital

    Tokyo, Bunkyo-Ku, 113-8603

  • National Hospital Organization Disaster Medical Center

    Tokyo, Tachikawa, 190-0014

  • Yamagata City Hospital SAISEIKAN

    Yamagata, Yamagata, 990-8533

Other trials in Japan

France11 sites

  • HOP Trousseau

    Chambray-lès-Tours, 37170

  • HOP Bocage

    Dijon, 21079

  • HOP André Mignot

    Le Chesnay, 78150

  • HOP Lille, SAMU 59, Lille

    Lille, 59037

  • HOP Dupuytren

    Limoges, 87042

  • HOP Herriot

    Lyon, 69003

  • HOP Lapeyronie

    Montpellier, 34295

  • HOP Haut-Lévêque

    Pessac, 33604

  • HOP Lyon Sud

    Pierre-Bénite, 69495

  • HOP Nord

    Saint-Priest-en-Jarez, 42270

  • HOP Sainte Anne, Urgence, Toulon

    Toulon, 83041

Other trials in France

Poland8 sites

  • Univ. Clinic Hosp, Bialystok

    Bialystok, 15276

  • University Clinical Center, Gdansk

    Gdansk, 80952

  • Saint Wincenty a Paulo Hosp., Cardiology Dept., Gdynia

    Gdynia, 81348

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

    Kielce, 25736

  • The John Paul II Hosp.,Dept.of Coronary Heart Disease,Krakow

    Krakow, 31202

  • Stefan Kardynal Wyszynski Reg.Hosp,Cardiol&IntensUnit,Lublin

    Lublin, 20718

  • Independent Public Healthcare, Dept. of Cardiology, Pulawy

    Puławy, 24100

  • Central Hosp.Minis.Interior,Dep.Noninvasive Cardiol,Warszawa

    Warsaw, 02507

Other trials in Poland

United Kingdom7 sites

  • North Hampshire Hospital

    Basingstoke, RG24 9NA

  • Royal Liverpool University Hospital

    Liverpool, L7 8XP

  • Royal London Hospital

    London, E1 1ES

  • St George's Hospital

    London, SW17 0QT

  • Emergency Department, John Radcliffe Hospital, Oxford

    Oxford, OX3 9DU

  • Southampton General Hospital

    Southampton, SO16 6YD

  • Musgrove Park Hospital

    Taunton, TA1 5DA

Other trials in United Kingdom

Australia6 sites

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • St. Vincents Hospital (MEL)

    Fitzroy, Victoria, 3065

  • St George Hospital

    Kogarah, New South Wales, 2217

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

  • Westmead Hospital-Clinical Haematology Dept

    Westmead, New South Wales, 2145

Other trials in Australia

Belgium6 sites

  • Aalst - HOSP Onze-Lieve-Vrouw

    Aalst, 9300

  • Brussels - UNIV St-Pierre

    Brussels, 1000

  • Brussels - UNIV UZ Brussel

    Brussels, 1090

  • Brussels - UNIV St-Luc

    Brussels, 1200

  • Genk - HOSP ZOL (St-Jan)

    Genk, 3600

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

Czechia6 sites

  • University Hospital Brno

    Brno, 625 00

  • Hospital,Neurology Dept,Ceske Budejovice

    České Budějovice, 370 01

  • Hospital Hradec Kralove

    Hradec Králové, 500 05

  • Regional Hospital Liberec

    Liberec, 460 63

  • Univ. Hospital Kralovske Vinohrady

    Prague, 100 34

  • University Hospital Motol

    Prague, 150 06

Other trials in Czechia

Netherlands6 sites

  • OLVG, locatie Oosterpark

    Amsterdam, 1091 AC

  • Academisch Medisch Centrum (AMC)

    Amsterdam, 1105 AZ

  • Martini Ziekenhuis

    Groningen, 9728 NT

  • Maastricht Universitair Medisch Centrum

    Maastricht, 6229 ER

  • Radboud Universitair Medisch Centrum

    Nijmegen, 6525 GA

  • Erasmus Medisch Centrum

    Rotterdam, 3015 CE

Other trials in Netherlands

Finland5 sites

  • HUS, Kirurginen päivystysosasto P1P, Meilahti, Helsinki

    Helsinki, 00290

  • Keski-Suomen keskussairaala

    Jyväskylä, 40620

  • Oulun yliopistollinen keskussairaala

    Oulu, 90220

  • TAYS, Acuta, Tampere

    Tampere, 33521

  • TYKS, Akuutti sisätautihoito ASIS, Turku

    Turku, 20521

Other trials in Finland

Italy5 sites

  • Azienda Ospedaliera Careggi

    Florence, 50134

  • Ospedale S.Maria della Misericordia, AO di Perugia

    Perugia, 06132

  • Azienda Unità Sanitaria Locale di Reggio Emilia

    Reggio Emilia, 42123

  • Policlinico Gemelli

    Roma, 00168

  • Az. Osp. S.Giovanni-Addolorata

    Roma, 00184

Other trials in Italy

New Zealand5 sites

  • Christchurch Hospital

    Christchurch, 8011

  • Auckland City Hospital

    Grafton / Auckland, 1023

  • Waikato Hospital

    Hamilton, 3240

  • Middlemore Hospital

    Otahuhu South Auckland, 2025

  • North Shore Hospital, Takapuna

    Takapuna Auckland, 0620

Other trials in New Zealand

Norway5 sites

  • Haukeland Universitetssykehus

    Bergen, N-5021

  • Vestre Viken HF, Drammen Sykehus

    Drammen, N-3004

  • Sykehuset Østfold Kalnes

    Grålum, N-1714

  • Oslo Universitetssykehus HF, Ullevål sykehus

    Oslo, N-0424

  • Universitetssykehuset Nord-Norge, Tromsø

    Tromsø, N-9038

Other trials in Norway

Austria4 sites

  • KH der Barmherzigen Schwestern Linz

    Linz, 4010

  • Kepler Univ. Klinikum Linz

    Linz, 4020

  • AKH - Medical University of Vienna

    Vienna, 1090

  • Wilhelminenspital

    Vienna, 1160

Other trials in Austria

Canada4 sites

  • Hamilton General Hospital

    Hamilton, Ontario, L8L 2X2

  • Juravinski Hospital

    Hamilton, Ontario, L8V 5C2

  • Jewish General Hospital

    Montreal, Migration Data, H3T 1E2

  • St. Paul's Hospital

    Vancouver, British Columbia, V1Y 1S1

Other trials in Canada

Colombia4 sites

  • Fundación Valle del Lili

    Cali, 760032

  • Centro Médico Imbanaco de Cali S.A.

    Cali, 760042

  • Fundación Cardiovascular de Colombia

    Floridablanca

  • Hospital Pablo Tobón Uribe

    Medellín, 50034

Other trials in Colombia

Israel4 sites

  • Rambam Medical Center

    Haifa, 3109601

  • Meir Medical Center

    Kfar Saba, 44281

  • The Chaim Sheba Medical Center Tel Hashomer

    Ramat Gan, 52621

  • Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Portugal4 sites

  • Centro Hospitalar da Cova da Beira Hospital Pêro da Covilhã

    Covilha, 6200-251

  • CHLO, EPE - Hospital S. Francisco Xavier

    Lisbon, 1495-005

  • Centro Hospitalar do Porto, EPE

    Porto, 4099-001

  • Centro Hospitalar São João,EPE

    Porto, 4202-451

Other trials in Portugal

Taiwan4 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • Far Eastern Memorial Hospital

    New Taipei City, 220

  • National Taiwan University Hospital

    Taipei, 100

  • Taipe Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

Germany3 sites

  • Vivantes Netzwerk für Gesundheit GmbH

    Berlin, 12351

  • Universitätsmedizin Greifswald

    Greifswald, 17475

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131

Other trials in Germany

Hong Kong3 sites

  • Pamela Youde Nethersole Eastern Hospital

    Hong Kong, 0

  • Prince of Wales Hospital

    Hong Kong, 0

  • Prince of Wales Hosp, Dept of Med & Therapeutics

    Hong Kong

Other trials in Hong Kong

Singapore3 sites

  • National University Hospital

    Singapore, 119074

  • Singapore General Hospital

    Singapore, 169608

  • Changi General Hospital

    Singapore, 529889

Other trials in Singapore

Sweden3 sites

  • Sahlgrenska US, Göteborg

    Gothenburg, 413 45

  • Skånes universitetssjukhus

    Lund, 221 85

  • Akademiska sjukhuset

    Uppsala, 751 85

Other trials in Sweden

India2 sites

  • B.M. Birla Heart research Centre

    Kolkata, 700027

  • Fortis Escorts Heart Institute

    New Delhi, 110025

Other trials in India

Ireland2 sites

  • St James's Hospital

    Dublin, DUBLIN 8

  • Cork University Hospital

    Wilton

Other trials in Ireland

Russia2 sites

  • Military Medical Academy n.a. S. M. Kirov, St. Petersburg

    Saint Petersburg, 194175

  • City Pokrovskiy Hospital, Cardiology Dept., Saint Petersburg

    Saint Petersburg, 199 106

Other trials in Russia

South Africa2 sites

  • Dr. D. Adler

    Sandton, 2021

  • Dr. Engelbrecht

    Somerset West, 7130

Other trials in South Africa

South Korea2 sites

  • Seoul National University Bundang Hospital

    Seongnam, 463-707

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

    Seoul, 137-701

Other trials in South Korea

Argentina1 site

  • Centro Privado de Cardiología

    San Miguel de Tucumán, ZC4000

Other trials in Argentina

Brazil1 site

  • Hospital Nossa Senhora de Pompéia

    Caxias do Sul, 95010-005

Other trials in Brazil

Denmark1 site

  • Aarhus Universitetshospital

    Aarhus C, 8000

Other trials in Denmark

Mexico1 site

  • Hospital Cardiologica Aguascalientes

    Aguascalientes, 20297

Other trials in Mexico

About this study

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

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.

Conditions
Hemorrhage
Being tested
idarucizumab
Medical subject headings
Hemorrhage

What participants receive

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

  • idarucizumabDrug

    idarucizumab

Study groups in NCT02104947
Study groupRoleWhat they receive
idarucizumabExperimentalidarucizumab Only 1 treatment, no placebo or comparator
Receives: Drug: idarucizumab

What is being measured

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

  1. 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.

    Measured: from the end of the first infusion up to 4 hours after the last infusion on Day 1

Secondary outcomes (6)

  1. 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.

    Measured: from the end of the first infusion up to 4 hours after the last infusion on Day 1

  2. 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.

    Measured: from the first infusion up to 24 hours after the last infusion on Day 1

  3. 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.

    Measured: within 24 hours of surgery

  4. 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.

    Measured: from the first infusion up to 24 hours after the last infusion on Day 1

  5. 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.

    Measured: Since the end of first vial of idarucizumab up to 4 hours after the completion of second vial

  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

    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.

    Measured: after the first vial of idarucizumab and before the start of second vial on Day1

Timeline

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

  1. First posted7 Apr 2014 (estimated)
  2. Study start6 May 2014
  3. Primary completion25 Jul 2016
  4. Study completion20 Oct 2016

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
503 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02104947
Sponsor's protocol ID
1321.3
Other IDs
2013-004813-41
Status last verified
Jan 2018
First submitted
2 Apr 2014
Last updated
5 Jan 2018

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.

    PubMed 31582135

  • 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.

    PubMed 31050868

  • 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.

    PubMed 30586692

  • 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.

    PubMed 28693366

  • 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.

    PubMed 26095746

  • 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.

    PubMed 26020620

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing idarucizumab in people with Hemorrhage, run by Boehringer Ingelheim at 176 sites in 33 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 10 inclusion and 7 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 5 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 176 sites in United States, Spain, Japan, France, Poland and 28 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 18 Aug 2017). 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?

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). 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 NCT02104947, 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 5 Jan 2018.

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