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AzTrials

Arthroplasty, Replacement, KneePhase 3NCT00152971

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

A Phase 3 study testing Dabigatran Dose 1 - day 2 to completion, Dabigatran Dose 1 - day 1 and Dabigatran Dose 2 - day 2 to completion in people with Arthroplasty, Replacement, Knee and Thromboembolism, run by Boehringer Ingelheim at 94 sites in 4 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

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dabigatran Dose 1 - day 2 to completion, Dabigatran Dose 1 - day 1 and Dabigatran Dose 2 - day 2 to completion
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,615 participants
Where
94 sitesin 4 countries
Study dates
Nov 2004to Jun 2006
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

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

Who cannot join

  • History of bleeding diathesis.
  • Constitutional or acquired coagulation disorders that in the investigator's judgment puts the patient at excessive risk for bleeding.
  • Major surgery or trauma (e.g. hip fracture) within the last 3 months.
  • 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.
  • 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.
Show all 13Show fewer
  • Any history of hemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, arteriovenous (AV) malformation or aneurysm.
  • History of VTE or pre-existing condition requiring anticoagulant therapy.
  • Clinically relevant bleeding (e.g. gastrointestinal, pulmonary, intraocular or urogenital bleeding) within the last 6 months.
  • Gastric or duodenal ulcer within the last 6 months.
  • 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).
  • Elevated AST or ALT >2x upper limit of normal, based on central lab results or local lab results within 1 month before enrollment.
  • 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.

Trial locations and contacts

94 sites in 4 countries.

94 sites in 4 countries

United States59 sites

  • 1160.24.01012 Anderson Orthopedic Clinic

    Alexandria, Virginia

  • 1160.24.01063 Resurgens Orthopaedics

    Atlanta, Georgia

  • 1160.24.01072 Resurgeons Orthopedics

    Atlanta, Georgia

  • 1160.24.01031 Colorodo Orthopedic Consultants, PC

    Aurora, Colorado

  • 1160.24.01032 Seton Medical Center

    Austin, Texas

  • 1160.24.01070 Sinai Hospital of Baltimore

    Baltimore, Maryland

  • 1160.24.01020 Bay Pines VA Medical Center

    Bay Pines, Florida

  • 1160.24.01002 The Orthopedic and Neurological Center of the Cascades

    Bend, Oregon

  • 1160.24.01074 Capstone Clinical Trials, Inc.

    Birmingham, Alabama

  • 1160.24.01028 Intermountain Research Center

    Boise, Idaho

  • 1160.24.01024 Pulmonary Associates of Brandon Clinical Research

    Brandon, Florida

  • 1160.24.01016

    Charleston, South Carolina

  • 1160.24.01014 Charlotte Orthopedic Specialists

    Charlotte, North Carolina

  • 1160.24.01035 Wellington Orthopedics and Sports Medicine

    Cincinnati, Ohio

  • 1160.24.01030 Alliance Research, Inc.

    Clearwater, Florida

  • 1160.24.01073 Coastal Orthopedic Associates, PA

    Conway, South Carolina

  • 1160.24.01003 Texas Orthopedic Associates

    Dallas, Texas

  • 1160.24.01090 VA Medical Center

    Dallas, Texas

  • 1160.24.01039 Florida Orthopedic Associates

    DeLand, Florida

  • 1160.24.01027 Advanced Orthopedic and Sports Medicine Specialists, PC

    Denver, Colorado

  • 1160.24.01022 Iowa Orthopedic Clinic

    Des Moines, Iowa

  • 1160.24.01041 Core Orthopedic Medical Center

    Encinitas, California

  • 1160.24.01023 Orthopedic Physicians of Colorado, PC

    Engelwood, Colorado

  • 1160.24.01034 Glendale Adventist Medical Center

    Glendale, California

  • 1160.24.01036 Orthopaedic Associates of South Broward, PA

    Hollywood, Florida

  • 1160.24.01026 James Muntz, MD

    Houston, Texas

  • 1160.24.01033 Bone and Joint Clinic of Houston

    Houston, Texas

  • 1160.24.01076 Discovery Alliance

    Houston, Texas

  • 1160.24.01059 Rockhill Orthopaedics

    Kansas City, Missouri

  • 1160.24.01005 Scripps Clinical Ctr for Orthopedic Rsrch & Educ

    La Jolla, California

  • 1160.24.01056 Southern Orthopaedic Specialists

    Lawrencville, Georgia

  • 1160.24.01008 Bluegrass Orthopedic/Musculoskeletal Research, LLC

    Lexington, Kentucky

  • 1160.24.01025 Martin, Bowen, Hefley Knee and Sports

    Little Rock, Arkansas

  • 1160.24.01053 OrthoArkansas, PA

    Little Rock, Arkansas

  • 1160.24.01085 Martin, Bowen, Hefley Knee and Sports

    Little Rock, Arkansas

  • 1160.24.01077 Long Beach VA Healthcare system

    Long Beach, California

  • 1160.24.01018 Gill Research Center

    Lubbock, Texas

  • 1160.24.01010 MIMA Century Research Associates

    Melbourne, Florida

  • 1160.24.01062 Miami Institute for Joint Reconstruction

    Miami, Florida

  • 1160.24.01042 Center for Joint Care

    Missoula, Montana

  • 1160.24.01079 West AL Research, Inc

    Northport, Alabama

  • 1160.24.01006 VA Medical Center

    Oklahoma City, Oklahoma

  • 1160.24.01064 Orthopedic Specialty Institute

    Orange, California

  • 1160.24.01040 Southern Clinical Research Consultants

    Orlando, Florida

  • 1160.24.01067 Baptist Clinical Research

    Pensacola, Florida

  • 1160.24.01046 Boehringer Ingelheim Investigational Site

    Philadelphia, Pennsylvania

  • 1160.24.01001 Boehringer Ingelheim Investigational Site

    Pinellas Park, Florida

  • 1160.24.01017 Boehringer Ingelheim Investigational Site

    Pinellas Park, Florida

  • 1160.24.01019 Boehringer Ingelheim Investigational Site

    Pinellas Park, Florida

  • 1160.24.01069 Correspondence and Pateint vists

    Plano, Texas

  • 1160.24.01029 Coastal Medical Research

    Port Orange, Florida

  • 1160.24.01015 Unlimited Research, LP

    San Antonio, Texas

  • 1160.24.01052 Swedish Medical Center

    Seattle, Washington

  • 1160.24.01057 Orthopedic Specialty Clinic of Spokane, PLLC

    Spokane, Washington

  • 1160.24.01082 MultiCare Health System

    Tacoma, Washington

  • 1160.24.01038 James A. Haley VA Hospital

    Tampa, Florida

  • 1160.24.01007 Ortho Associates

    Towson, Maryland

  • 1160.24.01047 Tucson Orhtopaedic Institute

    Tucson, Arizona

  • 1160.24.01044 Tulsa Bone and Joint Associates

    Tulsa, Oklahoma

Other trials in United States

Canada32 sites

  • 1160.24.02021 Rouge Valley Health System

    Ajax, Ontario

  • 1160.24.02008 Orthopaedic Surgery

    Barrie, Ontario

  • 1160.24.02016 Orthopaedic Surgery

    Brantford, Ontario

  • 1160.24.02010 Joseph Brant Memorial Hospital

    Burlington, Ontario

  • 1160.24.02013 Queen Elizabeth Hospital

    Charlottetown, Prince Edward Island

  • 1160.24.02031 University of Alberta Hospital

    Edmonton, Alberta

  • 1160.24.02036 2B2.37 Walter Mackenizie Centre

    Edmonton, Alberta

  • 1160.24.02007 Orthopaedics 4NE

    Fredericton, New Brunswick

  • 1160.24.02001 73 Delhi Street

    Guelph, Ontario

  • 1160.24.02014 565 Sanatorium Road

    Hamilton, Ontario

  • 1160.24.02032 Kelowna General Hospital

    Kelowna, British Columbia

  • 1160.24.02004 Grand River Hospital

    Kitchener, Ontario

  • 1160.24.02028 NHS- Greater Niagara General Site

    Niagara Falls, Ontario

  • 1160.24.02022 Lakeridge Health Oshawa

    Oshawa, Ontario

  • 1160.24.02017 1053 Carling Avenue

    Ottawa, Ontario

  • 1160.24.02026 Ottawa Hospital - General Campus

    Ottawa, Ontario

  • 1160.24.02024 Red Deer Regional Hospital

    Red Deer, Alberta

  • 1160.24.02015 York Central Hospital Research

    Richmond Hill, Ontario

  • 1160.24.02029 Niagara Health System St. Catharine's General Site

    Saint Catherine's, Ontario

  • 1160.24.02027 Atlantic Health Sciences Corporation

    Saint John, New Brunswick

  • 1160.24.02009 2863 Ellesmere Road

    Scarborough Village, Ontario

  • 1160.24.02003 46 General Hospital Drive

    Stratford, Ontario

  • 1160.24.02033 Thunder Bay Regional Hospital

    Thunder Bay, Ontario

  • 1160.24.02002 Toronto East General Hospital Fracture Clinic

    Toronto, Ontario

  • 1160.24.02023 North York General Hospital

    Toronto, Ontario

  • 1160.24.02030 St. Joseph's Health Centre

    Toronto, Ontario

  • 1160.24.02034 Hematology/Oncology Research

    Vancouver, British Columbia

  • 1160.24.02006 206-477 King Street

    Welland, Ontario

  • 1160.24.02035 Humber River Regional Hospital

    Weston, Ontario

  • 1160.24.02011 Windsor Regional Hospital

    Windsor, Ontario

  • 1160.24.02012 Hotel Dieu Grace Hospital

    Windsor, Ontario

  • 1160.24.02025 Grace General Hospital

    Winnipeg, Manitoba

Other trials in Canada

Mexico2 sites

  • 1160.24.05009 Traumatologia, Planta Baja

    Guadalajara, Jalisco

  • 1160.24.05004

    México

Other trials in Mexico

United Kingdom1 site

  • 1160.24.44001 Ravenscourt Park Hospital

    London

Other trials in United Kingdom

About this study

Official title: 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

Being tested
Dabigatran Dose 1 - day 2 to completion, Dabigatran Dose 1 - day 1, Dabigatran Dose 2 - day 2 to completion, Dabigatran Dose 2 - day 1, Enoxaparin
Medical subject headings
Thromboembolism

What participants receive

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

  • Dabigatran Dose 1 - day 2 to completionDrug

    low dose regimen taken once daily

  • Dabigatran Dose 1 - day 1Drug

    low dose regimen taken once daily

  • Dabigatran Dose 2 - day 2 to completionDrug

    high dose regimen taken once daily

  • Dabigatran Dose 2 - day 1Drug

    high dose regimen taken once daily

  • EnoxaparinDrug

    30 mg subcutaneously twice daily

Study groups in NCT00152971
Study groupRoleWhat they receive
Dabigatran Dose 1Experimentallow dose regimen taken once daily
Receives: Drug: Dabigatran Dose 1 - day 2 to completion; Drug: Dabigatran Dose 1 - day 1
Dabigatran Dose 2Experimentalhigh dose regimen taken once daily
Receives: Drug: Dabigatran Dose 2 - day 2 to completion; Drug: Dabigatran Dose 2 - day 1
EnoxaparinActive comparator30 mg subcutaneously twice daily
Receives: Drug: Enoxaparin

What is being measured

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

  1. Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period

    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.

    Measured: First administration until 12-15 days

Secondary outcomes (8)

  1. Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period

    Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee

    Measured: First administration until 12-15 days

  2. Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period

    Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee

    Measured: First administration until 12-15 days

  3. Number of Participants With Total Deep Vein Thrombosis During Treatment Period

    Total Deep Vein Thrombosis as adjudicated by the VTE events committee

    Measured: First administration until 12-15 days

  4. Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period

    Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee

    Measured: First administration until 12-15 days

  5. Number of Participants With Pulmonary Embolism During Treatment Period

    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

    Measured: First administration until 12-15 days

  6. Number of Participants Who Died During Treatment Period

    All cause death, as adjudicated by the VTE events committee

    Measured: First administration until 12-15 days

  7. Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period

    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).

    Measured: 3 months

  8. Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period

    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.

    Measured: First administration until 12-15 days

Timeline

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

  1. First posted12 Sep 2005 (estimated)
  2. Study startNov 2004
  3. Primary completionJun 2006

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
2,615 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00152971
Sponsor's protocol ID
1160.24
Status last verified
Apr 2014
First submitted
8 Sep 2005
Last updated
5 May 2014

Publications

  • Rosencher N, Noack H, Feuring M, Clemens A, Friedman RJ, Eriksson BI. Type of anaesthesia and the safety and efficacy of thromboprophylaxis with enoxaparin or dabigatran etexilate in major orthopaedic surgery: pooled analysis of three randomized controlled trials. Thromb J. 2012 Jun 18;10(1):9. doi: 10.1186/1477-9560-10-9.

    PubMed 22709460

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dabigatran Dose 1 - day 2 to completion, Dabigatran Dose 1 - day 1 and Dabigatran Dose 2 - day 2 to completion in people with Arthroplasty, Replacement, Knee and Thromboembolism, run by Boehringer Ingelheim at 94 sites in 4 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 4 inclusion and 13 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 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 sites in United States, Canada, Mexico, United Kingdom. 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 17 Dec 2010). 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?

Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period (time frame: First administration until 12-15 days). 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 NCT00152971, which also lists 1 linked publication.

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 May 2014.

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