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This Study Looks at the Effects of Idarucizumab in Patients Who Take Dabigatran and Need Emergency Surgery or Are Bleeding

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ClinicalTrials.gov Identifier: NCT03343704
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:

The primary objective is to demonstrate reversal of the anticoagulant effect of dabigatran in patients treated with dabigatran etexilate who have uncontrolled or life-threatening bleeding requiring urgent intervention, and in patients treated with dabigatran etexilate who require emergency surgery or other invasive procedure.

The secondary objectives are to assess the reduction or cessation of bleeding, evaluate the clinical outcomes, safety and the pharmacokinetics of dabigatran in the presence of idarucizumab.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Idarucizumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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 Idarucizumab (BI 655075) in Patients Treated With Dabigatran Etexilate Who Have Uncontrolled Bleeding or Require Emergency Surgery or Procedures.
Actual Study Start Date : March 26, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Idarucizumab Drug: Idarucizumab
Intravenous
Other Name: PRAXBIND, Praxbind, Prizbind




Primary Outcome Measures :
  1. Maximum reversal of anticoagulant effect of dabigatran based on central laboratory determination of diluted thrombin time or ecarin clotting time [ Time Frame: Up to 4 hours after treatment ]

Secondary Outcome Measures :
  1. Time to cessation of bleeding (for Group A only) [ Time Frame: Up to 24 hours after treatment ]
  2. Occurrence of major bleeding (for Group B only) intraoperatively [ Time Frame: Up to 24 hours after treatment ]
  3. Minimum unbound sum (free) dabigatran concentrations at any time point since the end of first infusion up to 4 hours after the completion of the last infusion (Cmin,1). [ Time Frame: Up to 4 hours after treatment ]
  4. Reversal of anticoagulation as measured by activated partial thromboplastin time (aPTT) and thrombin time (TT) [ Time Frame: Up to 4 hours after treatment ]
  5. Numbers of patients with Adverse events including local tolerability [ Time Frame: up to 5 days and up to 37 days after treatment ]
  6. Numbers of patients with Serious adverse events [ Time Frame: up to 5 days and up to 37 days after treatment ]
  7. Numbers of patients with Adverse reactions (adverse events related to treatment) [ Time Frame: up to 5 days and up to 37 days after treatment ]
  8. Number of patients with immune reactions assessed by Adverse Event (AE) collection [ Time Frame: up to 5 days and up to 37 days after treatment ]
  9. Number of patients with thrombotic events (ischemic stroke, myocardial infarction, pulmonary embolism, deep vein thrombosis, systemic embolism) [ Time Frame: up to 5 days and up to 37 days after treatment ]


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

Inclusion criteria:

  • ≥ 18 years at screening.
  • Male or female patients. Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
  • Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
  • Currently taking dabigatran etexilate
  • They meet the following criteria:

    • Group A: Overt bleeding judged by the physician to require a reversal agent. OR
    • Group B: A condition requiring emergency surgery or invasive procedure where adequate hemostasis is required. Emergency is defined as within the following 8 hours.

Exclusion criteria:

Group A:

  • Patients with minor bleeding (e.g. 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 (subjects with hereditary fructose intolerance may react to sorbitol).

Group B:

  • 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 ClinicalTrials.gov identifier (NCT number): NCT03343704


Contacts
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Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
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China
Beijing Chao-Yang Hospital Recruiting
Beijing, China, 100020
Contact: Xinchun Yang    13701186229    cyyy_yxc@sohu.com   
Beijing AnZhen Hospital Recruiting
Beijing, China, 100029
Contact: Changsheng Ma    13501023599    chshma@vip.sina.com   
Peking University First Hospital Recruiting
Beijing, China, 100034
Contact: Jing Zhou    010-83572283    zhoujing123@yahoo.com   
Cardiovascular Institute and Fu Wai Hospital Recruiting
Beijing, China, 100037
Contact: Yanming Yang    +86 13501241275    yymfuwai@outlook.com   
The Second Hospital of Jilin University Recruiting
Changchun, China, 130041
Contact: Bin Liu    +8643188796598    liubin3333@vip.sina.com   
First Hospital of Jilin University Recruiting
Changchun, China
Contact: Yang Zheng    +8613756661288    zhengyang@jlu.edu.cn   
Xiangya Hospital, Central South University Recruiting
Changsha, China, 410008
Contact: Zaixin Yu    0731-84327491    yuzaixin@126.com   
First Affiliated Hospital of Dalian Medical University Recruiting
Dalian, China, 116011
Contact: Lianjun Gao    138-8967-3366    gaoljmd@126.com   
Guangdong Provincial People's Hospital Recruiting
Guangzhou, China, 510080
Contact: Shulin Wu    8620-83875453/83827812-10280    doctorwushulin@163.com   
The First Afiliated Hospital, Sun Yet-sen University Recruiting
Guangzhou, China, 510080
Contact: Yugang Dong    +8602087755766    332dong@163.com   
Sun yet-sen Memorial Hospital, Sun yet-sen Univesity Recruiting
Guangzhou, China, 510288
Contact: Jingfeng Wang    86(020)81332360    wangjingfeng2017@163.com   
2nd Affiliated Hosp Zhejiang University College of Medical Recruiting
Hangzhou, China, 310009
Contact: Jianan Wang    13805786328    wang_jian_an@vip.tom.com   
Zhejiang Province People's Hospital Recruiting
Hangzhou, China, 310014
Contact: Lihong Wang    13666690598    wlhhz@hotmail.com   
Zhejiang University School of Medicine SIR RUN RUN SHAW Hospital Recruiting
Hangzhou, China, 310016
Contact: Guosheng Fu    13605800707    fugs@medmail.com.cn   
The First Affilliated Hospital Of Kunming of Medical College Recruiting
Kunming, China, 650032
Contact: Zhaohui Meng    13629618097    zhaohui_mengky@163.com   
The Second Affiliated Hospital to Nanchang University Recruiting
Nanchang, China, 330006
Contact: Kui Hong    86 139-7911-1788    hongkui88@163.com   
Jiangsu Province Hospital Recruiting
Nanjing, Jiangsu Province, China, 210029
Contact: Minglong Chen    13809000791    chenminglong@njmu.edu.cn   
Nanjing First Hospital Recruiting
Nanjing, China, 210006
Contact: Hang Zhang    13951922158    dxh_nari@sina.com   
Zhongda Hospital Southeast University Recruiting
Nanjing, China, 210009
Contact: Hong Zhi    13813892472    yidasaizhu@126.com   
Ningbo First Hospital Recruiting
Ningbo, China, 315010
Contact: Hanbin Cui    13606581566    hanbincui@hotmail.com   
The affiliated hospital of medicalcollege qingdao university Recruiting
Qingdao, China, 266005
Contact: Shanglang Cai    0532-82911847    CslBI2018@163.com   
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, China, 200025
Contact: Liqun Wu    021-64370045    wuliqun89@hotmail.com   
Huashan Hospital, Fudan University Recruiting
Shanghai, China, 200040
Contact: Qiang Dong    021-52887145    qiang_dong163@163.com   
Shanghai First People's Hospital Recruiting
Shanghai, China, 200080
Contact: Shaowen Liu    13817825235    shaowen.liu@hotmail.com   
People's Hospital of Liaoning Province Recruiting
Shenyang, China, 110016
Contact: Zhanquan Li    +86-24-24016068    lzqlr@medmail.com.cn   
The First Affiliated Hospital of Xinjiang Medical University Recruiting
Urumqi, China, 830054
Contact: Baopeng Tang    0991-4365605    tangbaopeng1111@163.com   
The First Affiliated Hospital of Wenzhou Med College Recruiting
Wenzhou, China, 325000
Contact: Hao Zhou    13968801939    wyzh66@126.com   
Tongji Hospital, Tongji University Recruiting
Wuhan, China, 430030
Contact: Yan Wang    13697326307    newswangyan@126.com   
Renmin Hospital of Wuhan University Recruiting
Wuhan, China, 430060
Contact: He Huang    027-88041911 turn 80138    huanghe1977@hotmail.com   
Xuzhou Central Hospital Recruiting
Xuzhou, China, 221009
Contact: Bing Han    +8615305218127    hbing777@hotmail.com   
Sponsors and Collaborators
Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03343704     History of Changes
Other Study ID Numbers: 1321-0019
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Atrial Fibrillation
Emergencies
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Disease Attributes
Dabigatran
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants