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Dabigatran Etexilate vs Enoxaparin in Prevention of Venous Thromboembolism (VTE) Post Total Knee Replacement

2014年4月22日 更新者：Boehringer Ingelheim

A Phase III, Randomized, Parallel-group, Double-blind, Active Controlled Study to Investigate the Efficacy and Safety of Two Different Dose Regimens (75mg Day 1 Followed by 150 mg Day 2-completion, and 110 mg Day 1 Followed by 220 mg Day 2-completion) of Dabigatran Etexilate Administered Orally (Capsules), Compared to Enoxaparin 30 mg Twice a Day Subcutaneous for 12 - 15 Days in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Knee Replacement Surgery

To determine the comparative efficacy and safety of two different doses (75mg day 1 followed by 150 mg day 2-completion, and 110 mg day 1 followed by 220 mg day 2-completion) of dabigatran administered orally (capsules), compared to enoxaparin 30 mg twice a day subcutaneous, in prevention of venous thromboembolism in patients with primary elective total knee replacement surgery

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

2615

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 加拿大
    • Alberta
      • Edmonton、Alberta、加拿大
        • 1160.24.02031 University of Alberta Hospital
      • Edmonton、Alberta、加拿大
        • 1160.24.02036 2B2.37 Walter Mackenizie Centre
      • Red Deer、Alberta、加拿大
        • 1160.24.02024 Red Deer Regional Hospital
    • British Columbia
      • Kelowna、British Columbia、加拿大
        • 1160.24.02032 Kelowna General Hospital
      • Vancouver、British Columbia、加拿大
        • 1160.24.02034 Hematology/Oncology Research
    • Manitoba
      • Winnipeg、Manitoba、加拿大
        • 1160.24.02025 Grace General Hospital
    • New Brunswick
      • Fredericton、New Brunswick、加拿大
        • 1160.24.02007 Orthopaedics 4NE
      • Saint John、New Brunswick、加拿大
        • 1160.24.02027 Atlantic Health Sciences Corporation
    • Ontario
      • Ajax、Ontario、加拿大
        • 1160.24.02021 Rouge Valley Health System
      • Barrie、Ontario、加拿大
        • 1160.24.02008 Orthopaedic Surgery
      • Brantford、Ontario、加拿大
        • 1160.24.02016 Orthopaedic Surgery
      • Burlington、Ontario、加拿大
        • 1160.24.02010 Joseph Brant Memorial Hospital
      • Guelph、Ontario、加拿大
        • 1160.24.02001 73 Delhi Street
      • Hamilton、Ontario、加拿大
        • 1160.24.02014 565 Sanatorium Road
      • Kitchener、Ontario、加拿大
        • 1160.24.02004 Grand River Hospital
      • Niagara Falls、Ontario、加拿大
        • 1160.24.02028 NHS- Greater Niagara General Site
      • Oshawa、Ontario、加拿大
        • 1160.24.02022 Lakeridge Health Oshawa
      • Ottawa、Ontario、加拿大
        • 1160.24.02017 1053 Carling Avenue
      • Ottawa、Ontario、加拿大
        • 1160.24.02026 Ottawa Hospital - General Campus
      • Richmond Hill、Ontario、加拿大
        • 1160.24.02015 York Central Hospital Research
      • Scarborough、Ontario、加拿大
        • 1160.24.02009 2863 Ellesmere Road
      • St. Catherine's、Ontario、加拿大
        • 1160.24.02029 Niagara Health System St. Catharine's General Site
      • Stratford、Ontario、加拿大
        • 1160.24.02003 46 General Hospital Drive
      • Thunder Bay、Ontario、加拿大
        • 1160.24.02033 Thunder Bay Regional Hospital
      • Toronto、Ontario、加拿大
        • 1160.24.02002 Toronto East General Hospital Fracture Clinic
      • Toronto、Ontario、加拿大
        • 1160.24.02023 North York General Hospital
      • Toronto、Ontario、加拿大
        • 1160.24.02030 St. Joseph's Health Centre
      • Welland、Ontario、加拿大
        • 1160.24.02006 206-477 King Street
      • Weston、Ontario、加拿大
        • 1160.24.02035 Humber River Regional Hospital
      • Windsor、Ontario、加拿大
        • 1160.24.02011 Windsor Regional Hospital
      • Windsor、Ontario、加拿大
        • 1160.24.02012 Hotel Dieu Grace Hospital
    • Prince Edward Island
      • Charlottetown、Prince Edward Island、加拿大
        • 1160.24.02013 Queen Elizabeth Hospital
  • 墨西哥
      • Guadalajara, Jalisco、墨西哥
        • 1160.24.05009 Traumatologia, Planta Baja
      • México、墨西哥
        • 1160.24.05004
  • 美国
    • Alabama
      • Birmingham、Alabama、美国
        • 1160.24.01074 Capstone Clinical Trials, Inc.
      • Northport、Alabama、美国
        • 1160.24.01079 West AL Research, Inc
    • Arizona
      • Tucson、Arizona、美国
        • 1160.24.01047 Tucson Orhtopaedic Institute
    • Arkansas
      • Little Rock、Arkansas、美国
        • 1160.24.01025 Martin, Bowen, Hefley Knee and Sports
      • Little Rock、Arkansas、美国
        • 1160.24.01053 OrthoArkansas, PA
      • Little Rock、Arkansas、美国
        • 1160.24.01085 Martin, Bowen, Hefley Knee and Sports
    • California
      • Encinitas、California、美国
        • 1160.24.01041 Core Orthopedic Medical Center
      • Glendale、California、美国
        • 1160.24.01034 Glendale Adventist Medical Center
      • La Jolla、California、美国
        • 1160.24.01005 Scripps Clinical Ctr for Orthopedic Rsrch & Educ
      • Long Beach、California、美国
        • 1160.24.01077 Long Beach VA Healthcare system
      • Orange、California、美国
        • 1160.24.01064 Orthopedic Specialty Institute
    • Colorado
      • Aurora、Colorado、美国
        • 1160.24.01031 Colorodo Orthopedic Consultants, PC
      • Denver、Colorado、美国
        • 1160.24.01027 Advanced Orthopedic and Sports Medicine Specialists, PC
      • Engelwood、Colorado、美国
        • 1160.24.01023 Orthopedic Physicians of Colorado, PC
    • Florida
      • Bay Pines、Florida、美国
        • 1160.24.01020 Bay Pines VA Medical Center
      • Brandon、Florida、美国
        • 1160.24.01024 Pulmonary Associates of Brandon Clinical Research
      • Clearwater、Florida、美国
        • 1160.24.01030 Alliance Research, Inc.
      • Deland、Florida、美国
        • 1160.24.01039 Florida Orthopedic Associates
      • Hollywood、Florida、美国
        • 1160.24.01036 Orthopaedic Associates of South Broward, PA
      • Melbourne、Florida、美国
        • 1160.24.01010 MIMA Century Research Associates
      • Miami、Florida、美国
        • 1160.24.01062 Miami Institute for Joint Reconstruction
      • Orlando、Florida、美国
        • 1160.24.01040 Southern Clinical Research Consultants
      • Pensacola、Florida、美国
        • 1160.24.01067 Baptist Clinical Research
      • Pinellas Park、Florida、美国
        • 1160.24.01001 Boehringer Ingelheim Investigational Site
      • Pinellas Park、Florida、美国
        • 1160.24.01017 Boehringer Ingelheim Investigational Site
      • Pinellas Park、Florida、美国
        • 1160.24.01019 Boehringer Ingelheim Investigational Site
      • Port Orange、Florida、美国
        • 1160.24.01029 Coastal Medical Research
      • Tampa、Florida、美国
        • 1160.24.01038 James A. Haley VA Hospital
    • Georgia
      • Atlanta、Georgia、美国
        • 1160.24.01063 Resurgens Orthopaedics
      • Atlanta、Georgia、美国
        • 1160.24.01072 Resurgeons Orthopedics
      • Lawrencville、Georgia、美国
        • 1160.24.01056 Southern Orthopaedic Specialists
    • Idaho
      • Boise、Idaho、美国
        • 1160.24.01028 Intermountain Research Center
    • Iowa
      • Des Moines、Iowa、美国
        • 1160.24.01022 Iowa Orthopedic Clinic
    • Kentucky
      • Lexington、Kentucky、美国
        • 1160.24.01008 Bluegrass Orthopedic/Musculoskeletal Research, LLC
    • Maryland
      • Baltimore、Maryland、美国
        • 1160.24.01070 Sinai Hospital of Baltimore
      • Towson、Maryland、美国
        • 1160.24.01007 Ortho Associates
    • Missouri
      • Kansas City、Missouri、美国
        • 1160.24.01059 Rockhill Orthopaedics
    • Montana
      • Missoula、Montana、美国
        • 1160.24.01042 Center for Joint Care
    • North Carolina
      • Charlotte、North Carolina、美国
        • 1160.24.01014 Charlotte Orthopedic Specialists
    • Ohio
      • Cincinnati、Ohio、美国
        • 1160.24.01035 Wellington Orthopedics and Sports Medicine
    • Oklahoma
      • Oklahoma City、Oklahoma、美国
        • 1160.24.01006 VA Medical Center
      • Tulsa、Oklahoma、美国
        • 1160.24.01044 Tulsa Bone and Joint Associates
    • Oregon
      • Bend、Oregon、美国
        • 1160.24.01002 The Orthopedic and Neurological Center of the Cascades
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国
        • 1160.24.01046 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Charleston、South Carolina、美国
        • 1160.24.01016
      • Conway、South Carolina、美国
        • 1160.24.01073 Coastal Orthopedic Associates, PA
    • Texas
      • Austin、Texas、美国
        • 1160.24.01032 Seton Medical Center
      • Dallas、Texas、美国
        • 1160.24.01003 Texas Orthopedic Associates
      • Dallas、Texas、美国
        • 1160.24.01090 VA Medical Center
      • Houston、Texas、美国
        • 1160.24.01026 James Muntz, MD
      • Houston、Texas、美国
        • 1160.24.01033 Bone and Joint Clinic of Houston
      • Houston、Texas、美国
        • 1160.24.01076 Discovery Alliance
      • Lubbock、Texas、美国
        • 1160.24.01018 Gill Research Center
      • Plano、Texas、美国
        • 1160.24.01069 Correspondence and Pateint vists
      • San Antonio、Texas、美国
        • 1160.24.01015 Unlimited Research, LP
    • Virginia
      • Alexandria、Virginia、美国
        • 1160.24.01012 Anderson Orthopedic Clinic
    • Washington
      • Seattle、Washington、美国
        • 1160.24.01052 Swedish Medical Center
      • Spokane、Washington、美国
        • 1160.24.01057 Orthopedic Specialty Clinic of Spokane, PLLC
      • Tacoma、Washington、美国
        • 1160.24.01082 MultiCare Health System
  • 英国
      • London、英国
        • 1160.24.44001 Ravenscourt Park Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion criteria INCLUSION CRITERIA

  1. Patients scheduled to undergo a primary, unilateral elective total knee repla cement.
  2. Male or female 18 years of age or older.
  3. Patients weighing at least 40 kg.
  4. Written informed consent prior to the start of study participation.

Exclusion criteria EXCLUSION CRITERIA

  1. History of bleeding diathesis.
  2. Constitutional or acquired coagulation disorders that in the investigator's judgment puts the patient at excessive risk for bleeding.
  3. Major surgery or trauma (e.g. hip fracture) within the last 3 months.
  4. Recent unstable cardiovascular disease, such as uncontrolled hypertension at the time of enrollment (investigator's judgment) or history of myocardial infarction within the last 3 months.

  5. Spinal or epidural anesthesia, for which more than 3 attempts (sticks) at placement were made, or the placement was traumatic.

    Please note that patients, who are not excluded under this criterion, are to have the catheter pulled at the completion of surgery.

  6. Any history of hemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, arteriovenous (AV) malformation or aneurysm.
  7. History of VTE or pre-existing condition requiring anticoagulant therapy.
  8. Clinically relevant bleeding (e.g. gastrointestinal, pulmonary, intraocular or urogenital bleeding) within the last 6 months.
  9. Gastric or duodenal ulcer within the last 6 months.
  10. Liver disease expected to have any potential impact on survival (e.g. hepatitis B or C, cirrhosis, but not Gilbert's syndrome or hepatitis A with complete recovery).
  11. Elevated AST or ALT >2x upper limit of normal, based on central lab results or local lab results within 1 month before enrollment.
  12. Known severe renal insufficiency (CrCl < 30 mL/min). In order to determine patient inclusion/exclusion, creatinine clearance (CrCl) needs to be calculated only if serum creatinine is elevated or renal insufficiency is suspected.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Dabigatran Dose 1
low dose regimen taken once daily
药品：Dabigatran Dose 1 - day 2 to completion
low dose regimen taken once daily
药品：Dabigatran Dose 1 - day 1
low dose regimen taken once daily
实验性的：Dabigatran Dose 2
high dose regimen taken once daily
药品：Dabigatran Dose 2 - day 2 to completion
high dose regimen taken once daily
药品：Dabigatran Dose 2 - day 1
high dose regimen taken once daily
有源比较器：Enoxaparin
30 mg subcutaneously twice daily
药品：Enoxaparin
30 mg subcutaneously twice daily

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period
大体时间：First administration until 12-15 days

Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).

All of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients.
First administration until 12-15 days

次要结果测量

结果测量
措施说明
大体时间
Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period
大体时间：First administration until 12-15 days
Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee
First administration until 12-15 days
Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period
大体时间：First administration until 12-15 days
Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee
First administration until 12-15 days
Number of Participants With Total Deep Vein Thrombosis During Treatment Period
大体时间：First administration until 12-15 days
Total Deep Vein Thrombosis as adjudicated by the VTE events committee
First administration until 12-15 days
Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period
大体时间：First administration until 12-15 days
Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee
First administration until 12-15 days
Number of Participants With Pulmonary Embolism During Treatment Period
大体时间：First administration until 12-15 days
Pulmonary embolism confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy, and as adjudicated by the VTE events committee
First administration until 12-15 days
Number of Participants Who Died During Treatment Period
大体时间：First administration until 12-15 days
All cause death, as adjudicated by the VTE events committee
First administration until 12-15 days
Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period
大体时间：3 months
Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).
3 months
Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period
大体时间：First administration until 12-15 days

Major bleeding events were defined as

  • fatal
  • clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected
  • clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected
  • symptomatic retroperitoneal, intracranial, intraocular or intraspinal
  • requiring treatment cessation
  • leading to re-operation

Clinically-relevant was defined as

  • spontaneous skin hematoma greater than or equal to 25 cm²
  • wound hematoma greater than or equal to 100 cm²
  • spontaneous nose bleed lasting longer than 5 min
  • macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention
  • spontaneous rectal bleeding (more than a spot on toilet paper)
  • gingival bleeding lasting longer than 5 min
  • any other bleeding event considered clinically relevant by the investigator

Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above.
First administration until 12-15 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Boehringer Ingelheim

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2004年11月1日

初级完成 (实际的)

2006年6月1日

研究完成

2022年12月7日

研究注册日期

首次提交

2005年9月8日

首先提交符合 QC 标准的

2005年9月8日

首次发布 (估计)

2005年9月12日

研究记录更新

最后更新发布 (估计)

2014年5月5日

上次提交的符合 QC 标准的更新

2014年4月22日

最后验证

2014年4月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 1160.24

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

Dabigatran Dose 1 - day 2 to completion的临床试验

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Tunisia

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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