Reversal of Dabigatran Anticoagulant Effect With Idarucizumab

NCT ID: NCT02104947

Last Updated: 2018-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 503 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-06
• Study Completion Date: 2016-10-20

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.

Conditions

Hemorrhage

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

idarucizumab

idarucizumab Only 1 treatment, no placebo or comparator

Group Type: EXPERIMENTAL

idarucizumab

Intervention Type: DRUG

idarucizumab

Interventions

idarucizumab

idarucizumab

Intervention Type: DRUG

Eligibility Criteria

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).

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

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Baptist Health Center for Clinical Research

Little Rock, Arkansas, United States

Loma Linda University Medical Center

Loma Linda, California, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

University of Florida College of Medicine

Gainesville, Florida, United States

Baptist Medical Center

Jacksonville, Florida, United States

Mayo Clinic Cancer Center

Jacksonville, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

St. Joseph's Hospital

Tampa, Florida, United States

Northwestern University

Chicago, Illinois, United States

OSF Saint Francis Medical Center

Peoria, Illinois, United States

IU Health Methodist Hospital

Indianapolis, Indiana, United States

Community Hospital

Munster, Indiana, United States

Our Lady of the Lake Regional Medical Center

Baton Rouge, Louisiana, United States

Newton-Wellesley Hospital

Newton, Massachusetts, United States

Genesys Regional Medical Center

Grand Blanc, Michigan, United States

Henry Ford Allegiance Health

Jackson, Michigan, United States

Mercy Hospital St. Louis

St Louis, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Duke University Medical Center

Durham, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

Miami Valley Hospital

Dayton, Ohio, United States

St. Elizabeth Youngstown Hospital

Youngstown, Ohio, United States

St. John Health System Inc

Tulsa, Oklahoma, United States

St. Mary Medical Center

Langhorne, Pennsylvania, United States

Lankenau Medical Center

Wynnewood, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Texas Health Research and Education Institute

Fort Worth, Texas, United States

Memorial Hermann Hospital - Texas Medical Center

Houston, Texas, United States

Sentara RMH Medical Center

Harrisonburg, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Centro Privado de Cardiología

San Miguel de Tucumán, , Argentina

Concord Repatriation General Hospital

Concord, New South Wales, Australia

St George Hospital

Kogarah, New South Wales, Australia

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Westmead Hospital-Clinical Haematology Dept

Westmead, New South Wales, Australia

Flinders Medical Centre

Bedford Park, South Australia, Australia

St. Vincents Hospital (MEL)

Fitzroy, Victoria, Australia

KH der Barmherzigen Schwestern Linz

Linz, , Austria

Kepler Univ. Klinikum Linz

Linz, , Austria

AKH - Medical University of Vienna

Vienna, , Austria

Wilhelminenspital

Vienna, , Austria

Aalst - HOSP Onze-Lieve-Vrouw

Aalst, , Belgium

Brussels - UNIV St-Pierre

Brussels, , Belgium

Brussels - UNIV UZ Brussel

Brussels, , Belgium

Brussels - UNIV St-Luc

Brussels, , Belgium

Genk - HOSP ZOL (St-Jan)

Genk, , Belgium

UZ Leuven

Leuven, , Belgium

Hospital Nossa Senhora de Pompéia

Caxias do Sul, , Brazil

St. Paul's Hospital

Vancouver, British Columbia, Canada

Jewish General Hospital

Montreal, Migration Data, Canada

Hamilton General Hospital

Hamilton, Ontario, Canada

Juravinski Hospital

Hamilton, Ontario, Canada

Fundación Valle del Lili

Cali, , Colombia

Centro Médico Imbanaco de Cali S.A.

Cali, , Colombia

Fundación Cardiovascular de Colombia

Floridablanca, , Colombia

Hospital Pablo Tobón Uribe

Medellín, , Colombia

University Hospital Brno

Brno, , Czechia

Hospital,Neurology Dept,Ceske Budejovice

České Budějovice, , Czechia

Hospital Hradec Kralove

Hradec Králové, , Czechia

Regional Hospital Liberec

Liberec, , Czechia

Univ. Hospital Kralovske Vinohrady

Prague, , Czechia

University Hospital Motol

Prague, , Czechia

Aarhus Universitetshospital

Aarhus C, , Denmark

HUS, Kirurginen päivystysosasto P1P, Meilahti, Helsinki

Helsinki, , Finland

Keski-Suomen keskussairaala

Jyväskylä, , Finland

Oulun yliopistollinen keskussairaala

Oulu, , Finland

TAYS, Acuta, Tampere

Tampere, , Finland

TYKS, Akuutti sisätautihoito ASIS, Turku

Turku, , Finland

HOP Trousseau

Chambray-lès-Tours, , France

HOP Bocage

Dijon, , France

HOP André Mignot

Le Chesnay, , France

HOP Lille, SAMU 59, Lille

Lille, , France

HOP Dupuytren

Limoges, , France

HOP Herriot

Lyon, , France

HOP Lapeyronie

Montpellier, , France

HOP Haut-Lévêque

Pessac, , France

HOP Lyon Sud

Pierre-Bénite, , France

HOP Nord

Saint-Priest-en-Jarez, , France

HOP Sainte Anne, Urgence, Toulon

Toulon, , France

Vivantes Netzwerk für Gesundheit GmbH

Berlin, , Germany

Universitätsmedizin Greifswald

Greifswald, , Germany

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, , Germany

Pamela Youde Nethersole Eastern Hospital

Hong Kong, , Hong Kong

Prince of Wales Hospital

Hong Kong, , Hong Kong

Prince of Wales Hosp, Dept of Med & Therapeutics

Hong Kong, , Hong Kong

B.M. Birla Heart research Centre

Kolkata, , India

Fortis Escorts Heart Institute

New Delhi, , India

St James's Hospital

Dublin, , Ireland

Cork University Hospital

Wilton, , Ireland

Rambam Medical Center

Haifa, , Israel

Meir Medical Center

Kfar Saba, , Israel

The Chaim Sheba Medical Center Tel Hashomer

Ramat Gan, , Israel

Sourasky Medical Center

Tel Aviv, , Israel

Azienda Ospedaliera Careggi

Florence, , Italy

Ospedale S.Maria della Misericordia, AO di Perugia

Perugia, , Italy

Azienda Unità Sanitaria Locale di Reggio Emilia

Reggio Emilia, , Italy

Policlinico Gemelli

Roma, , Italy

Az. Osp. S.Giovanni-Addolorata

Roma, , Italy

Japanese Red Cross Nagoya Daini Hospital

Aichi, Nagoya, , Japan

Ehime Prefectural Central Hospital

Ehime, Matsuyama, , Japan

Fukuoka Tokushukai Medical Center

Fukuoka, Kasuga, , Japan

Ogaki Municipal Hospital

Gifu, Ogaki, , Japan

National Hospital Organization Takasaki General Medical Center

Gunma, Takasaki, , Japan

Hyogo College of Medicine Hospital

Hyogo, Nishinomiya, , Japan

National Hospital Organization Kagoshima Medical Center

Kagoshima, Kagoshima, , Japan

Shonan Kamakura General Hospital

Kanagawa, Kamakura, , Japan

National Cerebral and Cardiovascular Center

Osaka, Suita, , Japan

Nippon Medical School Hospital

Tokyo, Bunkyo-Ku, , Japan

National Hospital Organization Disaster Medical Center

Tokyo, Tachikawa, , Japan

Yamagata City Hospital SAISEIKAN

Yamagata, Yamagata, , Japan

Hospital Cardiologica Aguascalientes

Aguascalientes, , Mexico

OLVG, locatie Oosterpark

Amsterdam, , Netherlands

Academisch Medisch Centrum (AMC)

Amsterdam, , Netherlands

Martini Ziekenhuis

Groningen, , Netherlands

Maastricht Universitair Medisch Centrum

Maastricht, , Netherlands

Radboud Universitair Medisch Centrum

Nijmegen, , Netherlands

Erasmus Medisch Centrum

Rotterdam, , Netherlands

Christchurch Hospital

Christchurch, , New Zealand

Auckland City Hospital

Grafton / Auckland, , New Zealand

Waikato Hospital

Hamilton, , New Zealand

Middlemore Hospital

Otahuhu South Auckland, , New Zealand

North Shore Hospital, Takapuna

Takapuna Auckland, , New Zealand

Haukeland Universitetssykehus

Bergen, , Norway

Vestre Viken HF, Drammen Sykehus

Drammen, , Norway

Sykehuset Østfold Kalnes

Grålum, , Norway

Oslo Universitetssykehus HF, Ullevål sykehus

Oslo, , Norway

Universitetssykehuset Nord-Norge, Tromsø

Tromsø, , Norway

Univ. Clinic Hosp, Bialystok

Bialystok, , Poland

University Clinical Center, Gdansk

Gdansk, , Poland

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

Gdynia, , Poland

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

Kielce, , Poland

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

Krakow, , Poland

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

Lublin, , Poland

Independent Public Healthcare, Dept. of Cardiology, Pulawy

Puławy, , Poland

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

Warsaw, , Poland

Centro Hospitalar da Cova da Beira Hospital Pêro da Covilhã

Covilha, , Portugal

CHLO, EPE - Hospital S. Francisco Xavier

Lisbon, , Portugal

Centro Hospitalar do Porto, EPE

Porto, , Portugal

Centro Hospitalar São João,EPE

Porto, , Portugal

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

Saint Petersburg, , Russia

City Pokrovskiy Hospital, Cardiology Dept., Saint Petersburg

Saint Petersburg, , Russia

National University Hospital

Singapore, , Singapore

Singapore General Hospital

Singapore, , Singapore

Changi General Hospital

Singapore, , Singapore

Dr. D. Adler

Sandton, , South Africa

Dr. Engelbrecht

Somerset West, , South Africa

Seoul National University Bundang Hospital

Seongnam, , South Korea

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

Seoul, , South Korea

Hospital General Universitario de Alicante

Alicante, , Spain

Hospital Vall d'Hebron

Barcelona, , Spain

Hospital Clínic de Barcelona

Barcelona, , Spain

Hospital de Bellvitge

Barcelona, , Spain

Hospital General Universitario Gregorio Marañón

Madrid, , Spain

Hospital Ramón y Cajal

Madrid, , Spain

Hospital Clínico San Carlos

Madrid, , Spain

Hospital La Paz

Madrid, , Spain

Hospital Regional Universitario de Málaga

Málaga, , Spain

Hospital Universitario Marqués de Valdecilla

Santander, , Spain

Hospital Politècnic La Fe

Valencia, , Spain

Hospital Clínico de Valencia

Valencia, , Spain

Hospital Álvaro Cunqueiro

Vigo (Pontevedra), , Spain

Hospital Clínico Universitario Lozano Blesa

Zaragoza, , Spain

Sahlgrenska US, Göteborg

Gothenburg, , Sweden

Skånes universitetssjukhus

Lund, , Sweden

Akademiska sjukhuset

Uppsala, , Sweden

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Far Eastern Memorial Hospital

New Taipei City, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Taipe Veterans General Hospital

Taipei, , Taiwan

North Hampshire Hospital

Basingstoke, , United Kingdom

Royal Liverpool University Hospital

Liverpool, , United Kingdom

Royal London Hospital

London, , United Kingdom

St George's Hospital

London, , United Kingdom

Emergency Department, John Radcliffe Hospital, Oxford

Oxford, , United Kingdom

Southampton General Hospital

Southampton, , United Kingdom

Musgrove Park Hospital

Taunton, , United Kingdom

Countries

United States; Argentina; Australia; Austria; Belgium; Brazil; Canada; Colombia; Czechia; Denmark; Finland; France; Germany; Hong Kong; India; Ireland; Israel; Italy; Japan; Mexico; Netherlands; New Zealand; Norway; Poland; Portugal; Russia; Singapore; South Africa; South Korea; Spain; Sweden; Taiwan; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 31582135 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31050868 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30586692 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28693366 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26095746 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26020620 (View on PubMed)

Other Identifiers

2013-004813-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1321.3

Identifier Type: -

Identifier Source: org_study_id