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Study of Apixaban for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery

Primary Purpose

Deep Vein Thrombosis, Pulmonary Embolism

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Enoxaparin + Placebo

Apixaban + Placebo

About this trial

This is an interventional prevention trial for Deep Vein Thrombosis focused on measuring Prevention of deep vein thrombosis and pulmonary embolism after total knee replacement surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

Men and non-pregnant, non-breastfeeding women
18 years or older
Scheduled for knee replacement surgery

Key Exclusion Criteria:

hereditary or acquired bleeding disorders
clotting disorders
bleeding or high risk for bleeding
drugs that affect bleeding or coagulation
need for ongoing parenteral or oral anticoagulation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm Description

+ placebo

Outcomes

Primary Outcome Measures

Event Rate of the Composite of Adjudicated Venous Thromboembolism (VTE) Events and All-Cause Death With Onset During the Intended Treatment Period - Primary Subjects

An Independent Central Adjudication Committee (ICAC) adjudicated all venograms, suspected symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE), acute clinically overt bleeding events, suspected thrombocytopenia, suspected acute MI, suspected acute stroke, and cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed and reported as percentage (%). Surgery=Day 1; Randomization/Treatment started on Day of Surgery or the next day (Day 1 or Day 2). A mandatory bilateral ascending contrast venogram was performed on all participants after 12 days (±2 days) of study treatment. Intended Treatment Period=starts on the day of randomization; for treated participants, the period ends at the latter of 2 days after last dose of study drug or 14 days after the first dose of study drug; for randomized participants who were not treated, the period ends 14 days after randomization.

Event Rate for Participants With Major Bleeding, Clinically Relevant Non-Major Bleeding, Major or Clinically Relevant Non-Major Bleeding, Any Bleeding With Onset During the Treatment Period - Treated Population

ICAC adjudicated acute clinically overt bleeding events as per International Society on Thrombosis and Hemostasis (ISTH) guidelines modified for surgical patients. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%). Clinically relevant (CR); Non-Major (N-M) Bleeding. Day 1=Day of surgery. Treatment started (first dose) day of surgery or next day. Treatment continued for 12 days.

Event Rate for Participants With Major Bleeding, Clinically Relevant (CR) Non-Major (N-M) Bleeding , Major or Clinically Relevant (CR) Non-Major (N-M) Bleeding, Any Bleeding With Onset During the Follow-Up Period

ICAC adjudicated acute clinically overt bleeding events as per International Society on Thrombosis and Hemostasis (ISTH) guidelines modified for surgical patients. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%). Follow up Period was from the end of the treatment period (last dose) up to 60 days post last dose, Day 72.

Secondary Outcome Measures

Event Rate of Composite of Adjudicated Proximal DVT, Non-Fatal PE and All-Cause Death With Onset During the Intended Treatment Period PE and All-cause Death During the Intended Treatment Period

A mandatory bilateral ascending contrast venogram was performed on all participants after 12 days (±2 days) of study treatment. An ICAC adjudicated all venograms, suspected proximal DVT and non-fatal PE, and all-cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed and reported as percentage (%).

Event Rate of Adjudicated VTE / VTE-related Death With Onset During the Treatment Period

VTE / VTE-related death was defined as the combination of fatal or non-fatal PE, and symptomatic or asymptomatic DVT. A mandatory bilateral ascending contrast venogram was performed on all participants after 12 days (±2 days) of study treatment. An ICAC adjudicated all venograms, suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%).

Event Rate for Participants With Proximal DVT/Non-Fatal PE/ VTE-Related Death With Onset During the Intended Treatment Period

An ICAC adjudicated all venograms, suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%).

Event Rate for Total Participants With Adjudicated VTE/All-Cause Death With Onset During the Intended Treatment Period

ICAC adjudicated all venograms, suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%).

Event Rate for Total Participants With VTE/ VTE-Related Death With Onset During the Intended Treatment Period

ICAC adjudicated all venograms, suspected symptomatic DVT and PE, and cause of death. VTE includes DVT and PE. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%).

Event Rate for Participants With All-Cause Death During the Intended Treatment Period

Event rate was number of participants with all-cause death divided by the number of participant's analyzed (%).

Event Rate for Participants With VTE-Related Death With Onset During the Intended Treatment Period

ICAC adjudicated cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%).

Event Rate for Participants With Symptomatic VTE/ All-Cause Death With Onset During the Intended Treatment Period

ICAC adjudicated suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%).

Event Rate for Participants With Symptomatic VTE/ VTE-Related Death With Onset During the Intended Treatment Period

ICAC adjudicated suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%).

Event Rate for Participants With VTE/Major Bleeding/All-Cause Death With Onset During the Intended Treatment Period

ICAC adjudicated VTE, acute clinically overt bleeding events, suspected thrombocytopenia, and cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%).

Event Rate for Participants With PE (Fatal or Non-Fatal), DVT (All, Symptomatic Proximal, and Distal, Asymptomatic) With Onset During the Intended Treatment Period

An ICAC adjudicated all venograms, suspected symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE), acute clinically overt bleeding events, suspected thrombocytopenia, suspected acute MI, suspected acute stroke, and cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%).

Event Rate for Participants With Proximal DVT, Distal DVT, Asymptomatic Proximal DVT, Asymptomatic Distal DVT With Onset During the Intended Treatment Period

ICAC adjudicated all venograms and suspected symptomatic DVT. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%).

Event Rate for Participants With Adjudicated Myocardial Infarction (MI) Acute Ischemic Stroke and Thromboembolic Events With Onset During the Treatment Period

ICAC adjudicated acute clinically overt bleeding events, suspected thrombocytopenia, suspected acute MI, suspected acute stroke per International Society on Thrombosis and Hemostasis (ISTH) guidelines modified for surgical patients. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%).

Event Rate of Adjudicated MI, Stroke, and Thrombocytopenia Events During the Follow-Up Period

A 60-day follow-up period started after the last dose of study drug and continued until the End of Study Visit on Day 72 (60 days ± 3 days, after the last dose of study drug). Event rate was number of participants with the endpoint divided by the number of participants analyzed (%). ICAC adjudicated acute clinically overt bleeding events, suspected thrombocytopenia, suspected acute MI, suspected acute stroke per ISTH guidelines modified for surgical patients.

Number of Participants With Serious Adverse Events (SAEs), Bleeding Adverse Events (AEs), AEs Leading to Discontinuation, and Deaths - Treated Population

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.

Mean Change From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period

Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug (12 + 2 days). Baseline=measurement prior to first dose of study drug. Blood pressures (BP) were measured during screening (pre-operative, post-operative) and in the treatment period on Days 1 (day of first dose), 2, 3, 4,12 (end of treatment). Systolic and diastolic pressures were measured in millimeters of mercury (mmHg).

Mean Change From Baseline in Heart Rate During the Treatment Period

Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug (12 + 2 days). Baseline=measurement prior to first dose of study drug. Heart rate was measured during screening (pre-operative, post-operative) and in the treatment period on Days 1 (day of first dose), 2, 3, 4,12 (end of treatment). Heart rate was measured in beats per minute (bpm).

Number of Participants With Hematology Laboratory Marked Abnormality During the Treatment Period

Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug. Hematology profile was measured during screening (pre-operative, post-operative) and in the Treatment Period on Days 2, 3, 4, 12 (end of treatment). Upper limit of normal (ULN); lower limit of normal (LLN). Platelet Count low: < 100,000/mm^3 (or < 100*109 cells/L). Erythrocytes low: < 0.75 *pre-dose. Hemoglobin low: > 2 g/dL decrease compared to pre-dose or Value ≤ 8 g/dL. Hematocrit low: < 0.75*pre-dose . Leukocytes: < 0.75*LLN or > 1.25* ULN, or if pre-dose < LLN then use < 0.8*predose or > ULN if pre-dose > ULN then use > 1.2*predose or < LLN. Lymphocytes (absolute): < 0.750*10^3 cells/µL or > 7.50*10^3 cells/ µL. Eosinophils (absolute) high: > 0.750*10^3 cells/µL. Basophils(absolute) high: > 400/mm^3 (or > 0.4*103 cells/µL). Monocytes (absolute) high: > 2000/mm^3 (or > 2*103 cells/µL). Neutrophils(absolute) high: < 1.0*103 cells/µL.

Number of Participants With Liver and Kidney Function Chemistry Laboratory Marked Abnormalities During the Treatment Period

Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug. Laboratory Chemistry profile was measured during screening (pre-operative, post-operative) and in the Treatment Period on Days 4, and 12 (end of treatment). Bilirubin (direct) high: > 1.5*ULN. Total bilirubin: : > 2*ULN, Alanine Aminotransferase (ALT) high: > 3*ULN. Alkaline Phosphatase (ALP): > 2*ULN. Aspartate Aminotransferase (AST): > 3*ULN. Creatinine: > 1.5*ULN.

Number of Participants With Electrolyte Chemistry Laboratory Marked Abnormalities During the Treatment Period

Laboratory Chemistry profile was measured during screening (pre-operative, post-operative) and in the Treatment Period on Days 4, and 12 (end of treatment). Potassium: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use < 0.9*predose or > ULN if pre-dose > ULN then use > 1.1*predose or < LLN. Calcium: < 0.8*LLN or > 1.2*ULN, or if pre-dose < LLN then use < 0.75*predose or > ULN If pre-dose > ULN then use > 1.25*predose or < LLN. Chloride: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use < 0.9*predose or > ULN if pre-dose > ULN then use > 1.1*predose or < LLN. Sodium: < 0.95*LLN or > 1.05*ULN, or if pre-dose < LLN then use < 0.95*predose or >ULN if pre-dose > ULN then use > 1.05*predose or < LLN. Bicarbonate: < 0.75*LLN or > 1.25*ULN, or if pre-dose < LLN then use < 0.75*predose or > ULN if pre-dose > ULN then use > 1.25*predose or < LLN.

Number of Participants With Other Chemistry Laboratory Marked Abnormalities During the Treatment Period

Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug. Laboratory Chemistry profile was measured during screening (pre-operative, post-operative) and in the Treatment Period on Days 4, and 12 (end of treatment). Fasting Glucose: if pre-dose < LLN then use < 0.8*predose; or > ULN if pre-dose > ULN then use > 2.0*predose or <LLN. Total Protein: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use 0.9*predose or > ULN if pre-dose > ULN then use 1.1*predose or < LLN. Uric Acid: > 1.5*ULN, or if pre-dose > ULN then use > 2*predose. Creatine Kinase (CK): > 5*ULN.

Full Information

NCT ID

NCT00371683

First Posted

August 30, 2006

Last Updated

November 25, 2015

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT00371683

Brief Title

Study of Apixaban for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery

Official Title

A Phase 3 Randomized, Double-Blind Active-Controlled (Enoxaparin), Parallel-Group, Multi-Center Study to Evaluate the Safety and Efficacy of Oral Apixaban in Subjects Undergoing Elective Total Knee Replacement Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

November 2006 (undefined)

Primary Completion Date

May 2008 (Actual)

Study Completion Date

May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein Thrombosis [DVT]) and lung (pulmonary embolism [PE]) that sometimes occur after knee replacement surgery and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be studied.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Deep Vein Thrombosis, Pulmonary Embolism

Keywords

Prevention of deep vein thrombosis and pulmonary embolism after total knee replacement surgery

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

3608 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

+ placebo

Arm Title

Arm Type

Experimental

Arm Description

+ placebo

Intervention Type

Drug

Intervention Name(s)

Enoxaparin + Placebo

Other Intervention Name(s)

Lovenox®

Intervention Description

Syringes + tablets, Subcutaneous + Oral, 30mg, twice daily, 12 day treatment period

Intervention Type

Drug

Intervention Name(s)

Apixaban + Placebo

Intervention Description

Tablet + Syringes, Oral + subcutaneous, 2.5 mg, twice daily, 12 day treatment period

Primary Outcome Measure Information:

Title

Event Rate of the Composite of Adjudicated Venous Thromboembolism (VTE) Events and All-Cause Death With Onset During the Intended Treatment Period - Primary Subjects

Description

Time Frame

From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization

Title

Description

Time Frame

First dose of study drug to last dose, plus 2 days post last dose

Title

Description

ICAC adjudicated acute clinically overt bleeding events as per International Society on Thrombosis and Hemostasis (ISTH) guidelines modified for surgical patients. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%). Follow up Period was from the end of the treatment period (last dose) up to 60 days post last dose, Day 72.

Time Frame

Last dose of study drug to Day 72 (60 days)

Secondary Outcome Measure Information:

Title

Event Rate of Composite of Adjudicated Proximal DVT, Non-Fatal PE and All-Cause Death With Onset During the Intended Treatment Period PE and All-cause Death During the Intended Treatment Period

Description

Time Frame

From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization

Title

Event Rate of Adjudicated VTE / VTE-related Death With Onset During the Treatment Period

Description

Time Frame

From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization

Title

Event Rate for Participants With Proximal DVT/Non-Fatal PE/ VTE-Related Death With Onset During the Intended Treatment Period

Description

An ICAC adjudicated all venograms, suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%).

Time Frame

From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization

Title

Event Rate for Total Participants With Adjudicated VTE/All-Cause Death With Onset During the Intended Treatment Period

Description

ICAC adjudicated all venograms, suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%).

Time Frame

From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization

Title

Event Rate for Total Participants With VTE/ VTE-Related Death With Onset During the Intended Treatment Period

Description

Time Frame

From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization

Title

Event Rate for Participants With All-Cause Death During the Intended Treatment Period

Description

Event rate was number of participants with all-cause death divided by the number of participant's analyzed (%).

Time Frame

From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization

Title

Event Rate for Participants With VTE-Related Death With Onset During the Intended Treatment Period

Description

ICAC adjudicated cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%).

Time Frame

From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization

Title

Event Rate for Participants With Symptomatic VTE/ All-Cause Death With Onset During the Intended Treatment Period

Description

ICAC adjudicated suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%).

Time Frame

From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization

Title

Event Rate for Participants With Symptomatic VTE/ VTE-Related Death With Onset During the Intended Treatment Period

Description

ICAC adjudicated suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%).

Time Frame

From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization

Title

Event Rate for Participants With VTE/Major Bleeding/All-Cause Death With Onset During the Intended Treatment Period

Description

Time Frame

From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization

Title

Event Rate for Participants With PE (Fatal or Non-Fatal), DVT (All, Symptomatic Proximal, and Distal, Asymptomatic) With Onset During the Intended Treatment Period

Description

Time Frame

From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization

Title

Event Rate for Participants With Proximal DVT, Distal DVT, Asymptomatic Proximal DVT, Asymptomatic Distal DVT With Onset During the Intended Treatment Period

Description

ICAC adjudicated all venograms and suspected symptomatic DVT. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%).

Time Frame

From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization

Title

Event Rate for Participants With Adjudicated Myocardial Infarction (MI) Acute Ischemic Stroke and Thromboembolic Events With Onset During the Treatment Period

Description

Time Frame

From first dose to last dose, plus 2 days (12 days, plus 2)

Title

Event Rate of Adjudicated MI, Stroke, and Thrombocytopenia Events During the Follow-Up Period

Description

Time Frame

Post last dose of study drug to Day 72 (60 days)

Title

Number of Participants With Serious Adverse Events (SAEs), Bleeding Adverse Events (AEs), AEs Leading to Discontinuation, and Deaths - Treated Population

Description

Time Frame

First dose to last dose, plus 2 days for AEs (12 + 2 days) or plus 30 days for SAEs (12 + 30 days)

Title

Mean Change From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period

Description

Time Frame

Baseline to last dose of study drug, plus 2 days

Title

Mean Change From Baseline in Heart Rate During the Treatment Period

Description

Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug (12 + 2 days). Baseline=measurement prior to first dose of study drug. Heart rate was measured during screening (pre-operative, post-operative) and in the treatment period on Days 1 (day of first dose), 2, 3, 4,12 (end of treatment). Heart rate was measured in beats per minute (bpm).

Time Frame

Baseline to last dose of study drug, plus 2 days

Title

Number of Participants With Hematology Laboratory Marked Abnormality During the Treatment Period

Description

Time Frame

First dose to last dose of study drug (12 days), plus 2 days

Title

Number of Participants With Liver and Kidney Function Chemistry Laboratory Marked Abnormalities During the Treatment Period

Description

Time Frame

First dose to last dose of study drug (12 days), plus 2 days

Title

Number of Participants With Electrolyte Chemistry Laboratory Marked Abnormalities During the Treatment Period

Description

Time Frame

First dose to last dose of study drug (12 days), plus 2 days

Title

Number of Participants With Other Chemistry Laboratory Marked Abnormalities During the Treatment Period

Description

Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug. Laboratory Chemistry profile was measured during screening (pre-operative, post-operative) and in the Treatment Period on Days 4, and 12 (end of treatment). Fasting Glucose: if pre-dose < LLN then use < 0.8*predose; or > ULN if pre-dose > ULN then use > 2.0*predose or <LLN. Total Protein: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use 0.9*predose or > ULN if pre-dose > ULN then use 1.1*predose or < LLN. Uric Acid: > 1.5*ULN, or if pre-dose > ULN then use > 2*predose. Creatine Kinase (CK): > 5*ULN.

Time Frame

First dose to last dose of study drug (12 days), plus 2 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Men and non-pregnant, non-breastfeeding women 18 years or older Scheduled for knee replacement surgery Key Exclusion Criteria: hereditary or acquired bleeding disorders clotting disorders bleeding or high risk for bleeding drugs that affect bleeding or coagulation need for ongoing parenteral or oral anticoagulation

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Capstone Clinical Trials, Inc

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35205

Country

United States

Facility Name

Capstone Clinical Trials, Inc

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35209

Country

United States

Facility Name

West Alabama Research, Inc.

City

Tuscaloosa

State/Province

Alabama

ZIP/Postal Code

35406

Country

United States

Facility Name

Martin Bowen Hefley Orthopedics

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Colorado Orthopedic Consultants, Pc

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80012

Country

United States

Facility Name

Colorado Joint Replacement

City

Denver

State/Province

Colorado

ZIP/Postal Code

80210

Country

United States

Facility Name

Jdpmedical Research

City

Denver

State/Province

Colorado

ZIP/Postal Code

80230

Country

United States

Facility Name

Orhtopaedic Physicians Of Colorado, P.C.

City

Englewood

State/Province

Colorado

ZIP/Postal Code

80113

Country

United States

Facility Name

Orthopedics Assocs Of Hartford

City

Hartford

State/Province

Connecticut

ZIP/Postal Code

06106

Country

United States

Facility Name

Anthony S. Unger, Md

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20006

Country

United States

Facility Name

Bay Pines Va Medical Center

City

Bay Pines

State/Province

Florida

ZIP/Postal Code

33744

Country

United States

Facility Name

Pab Clinical Research

City

Brandon

State/Province

Florida

ZIP/Postal Code

33511

Country

United States

Facility Name

Jacksonville Center For Clinical Research

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

Facility Name

Mark W. Hollmann, Md

City

Orange City

State/Province

Florida

ZIP/Postal Code

32763

Country

United States

Facility Name

Jewett Orthopaedic Clinic

City

Winter Park

State/Province

Florida

ZIP/Postal Code

32789

Country

United States

Facility Name

Atlanta Knee And Sports Medicine

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30033

Country

United States

Facility Name

Americana Orthopedics

City

Boise

State/Province

Idaho

ZIP/Postal Code

83702

Country

United States

Facility Name

Intermountain Orthopaedics

City

Boise

State/Province

Idaho

ZIP/Postal Code

83702

Country

United States

Facility Name

Bluegrass Orthopaedics/Bmr

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40509

Country

United States

Facility Name

Charleston Orthopaedic Assocs.

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29414

Country

United States

Facility Name

Kelsey Seybold Clinic

City

Houston

State/Province

Texas

ZIP/Postal Code

77025

Country

United States

Facility Name

Bone & Joint Clinic Of Houston

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Gill Orthopedic Center

City

Lubbock

State/Province

Texas

ZIP/Postal Code

79410

Country

United States

Facility Name

Robert R. King, Md

City

Lubbock

State/Province

Texas

ZIP/Postal Code

79410

Country

United States

Facility Name

Unlimited Research

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78217

Country

United States

Facility Name

Local Institution

City

Capital Federal

State/Province

Buenos Aires

ZIP/Postal Code

1012

Country

Argentina

Facility Name

Local Institution

City

Capital Federal

State/Province

Buenos Aires

ZIP/Postal Code

1426

Country

Argentina

Facility Name

Local Institution

City

Buenos Aires

ZIP/Postal Code

1280

Country

Argentina

Facility Name

Local Institution

City

Buenos Aires

ZIP/Postal Code

1425

Country

Argentina

Facility Name

Local Institution

City

Buenos Aires

ZIP/Postal Code

7540

Country

Argentina

Facility Name

Local Institution

City

Buenos Aires

ZIP/Postal Code

C1181

Country

Argentina

Facility Name

Local Institution

City

Cordoba

ZIP/Postal Code

5000

Country

Argentina

Facility Name

Local Institution

City

Garran

State/Province

Australian Capital Territory

ZIP/Postal Code

2605

Country

Australia

Facility Name

Local Institution

City

Camperdown

State/Province

New South Wales

ZIP/Postal Code

NSW 2050

Country

Australia

Facility Name

Local Institution

City

Caringbah

State/Province

New South Wales

ZIP/Postal Code

2229

Country

Australia

Facility Name

Local Institution

City

Lismore

State/Province

New South Wales

ZIP/Postal Code

2480

Country

Australia

Facility Name

Local Institution

City

Gold Coast

State/Province

Queensland

ZIP/Postal Code

4215

Country

Australia

Facility Name

Local Institution

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5011

Country

Australia

Facility Name

Local Institution

City

Bedford Park

State/Province

South Australia

ZIP/Postal Code

5042

Country

Australia

Facility Name

Local Institution

City

Box Hill

State/Province

Victoria

ZIP/Postal Code

3128

Country

Australia

Facility Name

Local Institution

City

Windsor

State/Province

Victoria

ZIP/Postal Code

3181

Country

Australia

Facility Name

Local Institution

City

Perth

State/Province

Western Australia

ZIP/Postal Code

6001

Country

Australia

Facility Name

Local Institution

City

Curitiba

State/Province

Parana

ZIP/Postal Code

80060

Country

Brazil

Facility Name

Local Institution

City

Porto Alegre, Rs

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90020

Country

Brazil

Facility Name

Local Institution

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90035

Country

Brazil

Facility Name

Local Institution

City

Campinas

State/Province

Sao Paulo

ZIP/Postal Code

13083

Country

Brazil

Facility Name

Local Institution

City

Sao Paulo

ZIP/Postal Code

05403

Country

Brazil

Facility Name

Local Institution

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2R7

Country

Canada

Facility Name

Local Institution

City

Ajax

State/Province

Ontario

ZIP/Postal Code

L1S 2J5

Country

Canada

Facility Name

Local Institution

City

Burlington

State/Province

Ontario

ZIP/Postal Code

L7R 4B7

Country

Canada

Facility Name

Local Institution

City

Cambridge

State/Province

Ontario

ZIP/Postal Code

N1R 7L7

Country

Canada

Facility Name

Local Institution

City

Chatham

State/Province

Ontario

ZIP/Postal Code

N7L 4T1

Country

Canada

Facility Name

Local Institution

City

Dartmouth

State/Province

Ontario

ZIP/Postal Code

B2Y 2N6

Country

Canada

Facility Name

Local Institution

City

Guelph

State/Province

Ontario

ZIP/Postal Code

N1E 6L9

Country

Canada

Facility Name

Local Institution

City

Lindsay

State/Province

Ontario

ZIP/Postal Code

K9V 4M8

Country

Canada

Facility Name

Local Institution

City

Newmarket

State/Province

Ontario

ZIP/Postal Code

L3Y 5G8

Country

Canada

Facility Name

Local Institution

City

Niagara Falls

State/Province

Ontario

ZIP/Postal Code

L2E 6X2

Country

Canada

Facility Name

Local Institution

City

Sarnia

State/Province

Ontario

ZIP/Postal Code

N7T 6H3

Country

Canada

Facility Name

Local Institution

City

Scarborough

State/Province

Ontario

ZIP/Postal Code

M1S 4T7

Country

Canada

Facility Name

Local Institution

City

Scarborough

State/Province

Ontario

ZIP/Postal Code

M3C 1W3

Country

Canada

Facility Name

Local Institution

City

St. Catharines

State/Province

Ontario

ZIP/Postal Code

L2R 7P3

Country

Canada

Facility Name

Local Institution

City

Stratford

State/Province

Ontario

ZIP/Postal Code

N5A 2N4

Country

Canada

Facility Name

Local Institution

City

Waterloo

State/Province

Ontario

ZIP/Postal Code

N2J 1C4

Country

Canada

Facility Name

Local Institution

City

Windsor

State/Province

Ontario

ZIP/Postal Code

N8W 1E6

Country

Canada

Facility Name

Local Institution

City

Charlottetown

State/Province

Prince Edward Island

ZIP/Postal Code

C1A 1L2

Country

Canada

Facility Name

Local Institution

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4J 1C5

Country

Canada

Facility Name

Local Institution

City

Quebec

ZIP/Postal Code

G1L 3L5

Country

Canada

Facility Name

Local Institution

City

Horsholm

ZIP/Postal Code

2970

Country

Denmark

Facility Name

Local Institution

City

Kopenhamn S

ZIP/Postal Code

2300

Country

Denmark

Facility Name

Local Institution

City

Kecskemet

ZIP/Postal Code

6000

Country

Hungary

Facility Name

Local Institution

City

Szekesfehervar

ZIP/Postal Code

8000

Country

Hungary

Facility Name

Local Institution

City

Szolnok

ZIP/Postal Code

5008

Country

Hungary

Facility Name

Local Institution

City

Afula

ZIP/Postal Code

18101

Country

Israel

Facility Name

Local Institution

City

Beer-Sheva

ZIP/Postal Code

84101

Country

Israel

Facility Name

Local Institution

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

Local Institution

City

Holon

ZIP/Postal Code

58100

Country

Israel

Facility Name

Local Institution

City

Kfar-Saba

ZIP/Postal Code

44281

Country

Israel

Facility Name

Local Institution

City

Petach-Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Local Institution

City

Rehovot

ZIP/Postal Code

76100

Country

Israel

Facility Name

Local Institution

City

Zerifin

ZIP/Postal Code

70300

Country

Israel

Facility Name

Local Institution

City

Tijuana

State/Province

Baja California

ZIP/Postal Code

22010

Country

Mexico

Facility Name

Local Institution

City

State/Province

Distrito Federal

ZIP/Postal Code

01030

Country

Mexico

Facility Name

Local Institution

City

State/Province

Distrito Federal

ZIP/Postal Code

05300

Country

Mexico

Facility Name

Local Institution

City

State/Province

Distrito Federal

ZIP/Postal Code

07760

Country

Mexico

Facility Name

Local Institution

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44280

Country

Mexico

Facility Name

Local Institution

City

Monterrey

State/Province

Nuevo Leon

ZIP/Postal Code

64000

Country

Mexico

Facility Name

Local Institution

City

Monterrey

State/Province

Nuevo Leon

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Local Institution

City

Cd Madero

State/Province

Tamaulipas

ZIP/Postal Code

89240

Country

Mexico

Facility Name

Local Institution

City

Jalapa

State/Province

Veracruz

ZIP/Postal Code

91020

Country

Mexico

Facility Name

Local Institution

City

Merida

State/Province

Yucatan

ZIP/Postal Code

97070

Country

Mexico

Facility Name

Local Institution

City

Merida

State/Province

Yucatan

ZIP/Postal Code

97133

Country

Mexico

Facility Name

Local Institution

City

Chihuahua

ZIP/Postal Code

31000

Country

Mexico

Facility Name

Local Institution

City

Bialystok

ZIP/Postal Code

15276

Country

Poland

Facility Name

Local Institution

City

Krakow

ZIP/Postal Code

31-826

Country

Poland

Facility Name

Local Institution

City

Lodz

ZIP/Postal Code

91002

Country

Poland

Facility Name

Local Institution

City

Lublin

ZIP/Postal Code

20954

Country

Poland

Facility Name

Local Institution

City

Szczecin

ZIP/Postal Code

71252

Country

Poland

Facility Name

Local Institution

City

Warszawa

ZIP/Postal Code

00909

Country

Poland

Facility Name

Local Institution

City

Warszawa

ZIP/Postal Code

02005

Country

Poland

Facility Name

Local Institution

City

Moscow

ZIP/Postal Code

117333

Country

Russian Federation

Facility Name

Local Institution

City

Samara

ZIP/Postal Code

443095

Country

Russian Federation

Facility Name

Local Institution

City

St. Petersburg

ZIP/Postal Code

195257

Country

Russian Federation

Facility Name

Local Institution

City

Goteborg

ZIP/Postal Code

416 85

Country

Sweden

Facility Name

Local Institution

City

Adana

ZIP/Postal Code

01330

Country

Turkey

Facility Name

Local Institution

City

Bursa

ZIP/Postal Code

16059

Country

Turkey

Facility Name

Local Institution

City

Mersin

ZIP/Postal Code

33163

Country

Turkey

Facility Name

Local Institution

City

Trabzon

ZIP/Postal Code

61030

Country

Turkey

12. IPD Sharing Statement

Citations:

PubMed Identifier

35570249

Citation

Jamieson MJ, Byon W, Dettloff RW, Crawford M, Gargalovic PS, Merali SJ, Onorato J, Quintero AJ, Russ C. Apixaban Use in Obese Patients: A Review of the Pharmacokinetic, Interventional, and Observational Study Data. Am J Cardiovasc Drugs. 2022 Nov;22(6):615-631. doi: 10.1007/s40256-022-00524-x. Epub 2022 May 16.

Results Reference

derived

PubMed Identifier

19657123

Citation

Lassen MR, Raskob GE, Gallus A, Pineo G, Chen D, Portman RJ. Apixaban or enoxaparin for thromboprophylaxis after knee replacement. N Engl J Med. 2009 Aug 6;361(6):594-604. doi: 10.1056/NEJMoa0810773. Erratum In: N Engl J Med. 2009 Oct 29;361(18):1814.

Results Reference

derived

Learn more about this trial

Study of Apixaban for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery

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Study of Apixaban for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery

Deep Vein Thrombosis, Pulmonary Embolism

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial