이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2014년 4월 22일 업데이트: 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

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

2615

단계

  • 3단계

연락처 및 위치

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연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Dabigatran Dose 1
low dose regimen taken once daily
의약품: Dabigatran Dose 1 - day 2 to completion
low dose regimen taken once daily
의약품: Dabigatran Dose 1 - day 1
low dose regimen taken once daily
실험적: Dabigatran Dose 2
high dose regimen taken once daily
의약품: Dabigatran Dose 2 - day 2 to completion
high dose regimen taken once daily
의약품: Dabigatran Dose 2 - day 1
high dose regimen taken once daily
활성 비교기: Enoxaparin
30 mg subcutaneously twice daily
의약품: Enoxaparin
30 mg subcutaneously twice daily

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Boehringer Ingelheim

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2004년 11월 1일

기본 완료 (실제)

2006년 6월 1일

연구 완료

2022년 12월 7일

연구 등록 날짜

최초 제출

2005년 9월 8일

QC 기준을 충족하는 최초 제출

2005년 9월 8일

처음 게시됨 (추정)

2005년 9월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2014년 5월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2014년 4월 22일

마지막으로 확인됨

2014년 4월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 1160.24

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다