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Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Hip Replacement Surgery (ADVANCE-3)

Primary Purpose

Deep Vein Thrombosis, Pulmonary Embolism

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Enoxaparin

Apixaban

Enoxaparin-matching placebo

Apixaban-matching 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 hip replacement surgery

Eligibility Criteria

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

Key Inclusion Criteria

Patients undergoing elective unilateral total hip replacement or a revision of at least 1 component of a total hip replacement.
Patients who were willing and able to undergo bilateral ascending contrast venography
Either sex, any race, 18 years and older

Key Exclusion Criteria

Known or suspected bleeding or coagulation disorder in the patient or his or her first-degree relative
Known or suspected history of heparin-induced thrombocytopenia
Known coagulopathy
Active bleeding or at high risk for bleeding
Brain, spinal, ophthalmologic, or major surgery or trauma within the past 90 days
Active hepatobiliary disease
Alcohol and/or substance abuse within the past year
Any condition for which surgery or administration of an anticoagulant is contraindicated
Two consecutive blood pressure readings within 15 to 30 minutes with supine systolic blood pressure >180 mm Hg or supine diastolic blood pressure >105 mm Hg
Clinically significant laboratory abnormalities at the enrollment visit:
Hemoglobin <10 g/dL
Platelet count <100,000/mm^3
Creatinine clearance <30 mL/min, as estimated by the method of Cockcroft and Gault
Alanine aminotransferase or aspartate aminotransferase >2*upper limit of normal or a total bilirubin ≥ 1.5*1 (unless an alternative causative factor such as Gilbert's syndrome was identified)
Need for ongoing treatment with a parenteral or oral anticoagulant (eg, subjects with mechanical valves, warfarin eligible atrial fibrillation)
Current use of dextrans or fibrinolytics
Treatment with medications affecting coagulation or platelet function

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Apixaban, 2.5 mg BID plus placebo

Enoxaparin, 40 mg QD plus placebo

Arm Description

Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)

Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID

Outcomes

Primary Outcome Measures

Rate of Composite of Adjudicated Venous Thromboembolic Event (VTE)-Related (Pulmonary Embolism and Symptomatic and Asymptomatic Deep Vein Thrombosis[DVT]) and All-cause Death During the Intended Treatment Period

Event rate=Number of events divided by the number of patients evaluated. A mandatory bilateral ascending contrast venogram was to be obtained on Day 35 (± 3). Patients with confirmed symptomatic DVT at any time, or asymptomatic DVT upon venography, were to receive treatment for DVT according to the investigator's standard of care. Signs and symptoms suggestive of VTE included, but were not limited to: 1) lower extremity DVT: erythema, warmth, pain, swelling, tenderness; and 2) PE: pleuritic chest pain, dyspnea, cough, hemoptysis, syncope, light-headedness/dizziness, tachypnea, and tachycardia. Intended Treatment Period started on day of randomization and, for patients who received treatment, ended at the later of 2 days after last dose of study drug or 38 days after the first dose (presurgery) of study drug. For randomized patients who did not receive study drug, the period ended 38 days after randomization.

Secondary Outcome Measures

Rate of Composite of Adjudicated Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism, and Venous Thromboembolic Event-related Death With Onset During Intended Treatment Period

Event rate=Number of events divided by the number of patients evaluated. Each patient was categorized as having no proximal DVT, having proximal DVT, being nonevaluable for proximal DVT, having no distal DVT, having distal DVT, or being nonevaluable for distal DVT. Adjudication criteria were: Normal=All deep veins were visualized, and there was no intraluminal filling defect (ILFD). ILFD=An area of reduced, or absent filling, at least partially surrounded with contrast medium in ≥ 2 projections or a lack of filling in a vessel in which there was a cut-off that had the configuration of a thrombus. Indeterminate=A lack of filling of a region of the deep vein system, proximal or distal, without the presence of an ILFD elsewhere in the same region. Not Done=A venography was not performed. Proximal DVT was found if any of the proximal veins had an ILFD. Pulmonary embolism was radiographically (angiography, V/Q scan, computed tomography) determined.

Rates of Adjudicated All-cause Death, VTE-related Death, Pulmonary Embolism (PE), Nonfatal PE, Deep Vein Thrombosis (DVT) (Symptomatic and Asymptomatic), Symptomatic and Asymptomatic Proximal and Distal DVT During the Intended Treatment Period

VTE=venous thromboembolic event; VTE-related death=combination of fatal or nonfatal PE and symptomatic or asymptomatic DVT. Event rate=Number of events divided by the number of patients evaluated.

Rate of Major Bleeding, Clinically Relevant Nonmajor Bleeding (CRNM), Major or CRNM, and Any Bleeding During the Treatment Period

Event rate=Number of events divided by the number of patients evaluated. Major bleeding event defined as a bleeding event that was 1) Acute clinically overt bleeding accompanied by at least 1 of the following: decrease in hemoglobin of ≥ 2 g/dL over a 24-hour period, transfusion of ≥2 units of packed red blood cells; bleeding that occurred in at least 1 of the following sites: intracranial, intra-spinal, intraocular, pericardial, an operated joint and requires reoperation or intervention, intramuscular with compartment syndrome, or retroperitoneal; 2) Fatal. CRNM was defined as acute clinically overt bleeding that did not satisfy the criteria for a major bleeding event and met at least 1 of the following: epistaxis, gastrointestinal bleed, hematuria, bruising/ecchymosis, or hemoptysis. Minor bleeding was defined as an acute clinically overt bleeding event that did not meet the criteria for major bleeding or a CRNM. Fatal bleeding event was defined as bleeding that was the primary

Number of Participants With Serious Adverse Events (SAEs), Bleeding Adverse Events (AEs), and Death as Outcome

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. All suspected bleeding events were to be reported by the investigator as either an AE or SAE and adjudicated by the Independent Central Adjudication Committee (ICAC). Definitions of bleeding outcomes: Acute clinically overt bleeding =new onset, visible bleeding, or signs or symptoms suggestive of bleeding with confirmatory imaging techniques that could detect the presence of blood.

Number of Participants With a Bleeding-related Adverse Event During the Treatment Period

All suspected bleeding events were to be reported by the investigator as either an adverse event or serious adverse event or and adjudicated by the Independent Central Adjudication Committee (ICAC). Definitions of bleeding outcomes: Acute clinically overt bleeding =new onset, visible bleeding, or signs or symptoms suggestive of bleeding with confirmatory imaging techniques that could detect the presence of blood. All acute clinically overt bleeding events were adjudicated by the ICAC as a major bleeding event or a clinically relevant nonmajor bleeding event; suspected minor bleeding events were not sent for adjudication.

Number of Participants With a Bleeding-related Adverse Events During the Treatment Period (Continued)

Number of Participants With a Bleeding-related Adverse Event During the Treatment Period (Continued)

Number of Participants With Neurologic Adverse Events With Onset During the Treatment Period

Neurologic events were based on Medical Dictionary for Regulatory Activities search categories.For new or worsening events that were not related to the site of surgery, additional information was collected on a specific form. In addition, neurology consultation was to be obtained for these patients.

Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period

preRx=predose; LLN=lower limit of normal; ULN=upper limit of normal. MA criteria: Hemoglobin: >2 g/dL decrease from preRx or value ≤ 8 g/dL; hematocrit (%): <0.75*preRx; platelet count (*10^9 cells/L): <100,000/mm^3; erythrocytes (*10^6 cells/μL): <0.75*preRx level; leukocytes (*10^3 cells/μL): < 0.75*LLN or >1.25*ULN, or if preRx LLN use < 0.8*preRx or >ULN if preRx >ULN use >1.2*preRx or <LLN; basophils (*10^3 cells/μL): >400/mm^3; eosinophils (*10^3 cells/μL): > 0.75*10^3 cells/μL; lymphocytes (*10^3 cells/μL): >0.75*10^3 cells/μL; monocytes (*10^3 cells/μL): >2000/mm^3; neutrophils (*10^3 cells/μL): <1.0;

Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period (Continued)

preRx=predose; LLN=lower limit of normal; ULN=upper limit of normal. Alanine aminotransferase (ALT) (U/L): >3 *ULN: alkaline phosphatase (ALP) (U/L): >2* ULN; aspartate aminotransferase (ASP) (U/L): >3 *ULN; bilirubin, direct (mg/dL): >2*ULN; bilirubin, total (mg/dL): >2*ULN; BUN (mg/dL): >2*ULN; creatinine (mg/dL): >1.5*ULN; calcium (mg/dL): < 0.8*LLN or >1.2 *ULN, or if preRx <LLN use <0.75* preRx or >ULN if preRx >ULN use > 1.25*preRx or <LLN; chloride (mEq/L): <0.9*LLN or >1.1*ULN, or if preRx <LLN use <0.9*preRx or >ULN if preRx >ULN use >1.1* preRx or <LLN; bicarbonate (mEq/L): < 0.75* LLN or >1.25*ULN, or if preRx <LLN use <0.75*preRx or >ULN if preRx >ULN use >1.25*preRx or <LLN; potassium (mEq/L): < 0.9*LLN or >1.1*ULN, or if preRx <LLN use <0.9*preRx or >ULN if preRx >ULN use >1.1* preRx or < LLN; sodium (mEq/L): <0.95* LLN or >1.05×ULN, or if preRx <LLN use <0.95* predose or >ULN if preRx >ULN use >1.05 *preRx or < LLN.

Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period (Continued)

preRx=predose; LLN=lower limit of normal; ULN=upper limit of normal. Glucose, fasting (mg/dL): <.8*LLN or >1.5*ULN, or if preRx <LLN use <.8*preRx or >ULN if preRx >ULN use >2*preRx or <LLN; protein, total (g/L): If missing preRx use ≥2, or if value ≥4 or preRx =0 or .5 use ≥2, or if preRx=1 use ≥3, or if preRx =2 or 3 use ≥4; creatine kinase (U/L): >5*ULN; uric acid (mg/dL): >.5* ULN, or if preRx >ULN use >2*preRx; blood, urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx =2 or 3 use ≥4; glucose, urine : If missing preRx use ≥2, or if value ≥4, or if preRx=0 or .5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; RBC, urine (hpf): If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx dose= 1 use ≥3, or if preRx=2 or 3 use ≥4; WBC, urine (h): If missing preRx use ≥2, or if value ≥4, or if preRx =0 or .5 use ≥2, or if preRx =1 use ≥3, or if preRx=2 or 3 use ≥4.

Number of Participants With Adverse Events Related to Elevations in Liver Function Test Results With Onset During the Treatment Period

Treatment guidelines were provided for jaundice and elevated results of liver function tests.

Rates of Adjudicated Myocardial Infarction (MI)/Stroke, MI, Stroke, and Thrombocytopenia During the Intended Treatment Period

Event rate=Number of events divided by the number of patients evaluated. All suspected events were reported by investigator. Acute MI=the presence of a clinical situation (eg, abnormal history, physical examination, new electrocardiogram changes) suggestive of an MI and at least 1 of the following: elevated creatine kinase (CK)-MB or troponin T or troponin I ≥2*upper limit of normal (ULN); if CK-MB or troponin values not available, total CK ≥2*ULN; or new significant (≥0.04 sec) Q waves in ≥2 contiguous leads. Stroke=a new focal neurologic deficit of sudden onset lasting at least 24 hours that was not due to a readily identifiable nonvascular cause. Adjudication classified each reported stroke as primary hemorrhagic, nonhemorrhagic, infarction with hemorrhagic conversion, or unknown type. Thrombocytopenia=after 3 days as drop in platelet count to <100,000/mm^3 for patients with a baseline value >150,000/mm^3 or a >50% decline, if the baseline value was ≤150,000/mm^3.

Full Information

NCT ID

NCT00423319

First Posted

January 17, 2007

Last Updated

April 14, 2014

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT00423319

Brief Title

Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Hip Replacement Surgery (ADVANCE-3)

Official Title

A Phase 3 Randomized, Double-blind, Active-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Apixaban in Subjects Undergoing Elective Total Hip Replacement Surgery (The Advance-3 Study Apixaban Dosed Orally Versus Anticoagulation With Injectable Enoxaparin to Prevent Venous Thromboembolism)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

September 2009 (Actual)

Study Completion Date

September 2009 (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 whether apixaban can prevent the blood clots in the leg (deep vein thrombosis) and lung (pulmonary embolism) that sometimes occur after hip replacement surgery and to learn how apixaban compares with enoxaparin in 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 hip replacement surgery

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

5407 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Apixaban, 2.5 mg BID plus placebo

Arm Type

Active Comparator

Arm Description

Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)

Arm Title

Enoxaparin, 40 mg QD plus placebo

Arm Type

Experimental

Arm Description

Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID

Intervention Type

Drug

Intervention Name(s)

Enoxaparin

Other Intervention Name(s)

Lovenox®

Intervention Description

Subcutaneous, 40 mg, once daily, 5 weeks

Intervention Type

Drug

Intervention Name(s)

Apixaban

Other Intervention Name(s)

BMS-562247, Eliquis®

Intervention Description

Oral tablets, 2.5 mg, twice daily, 5weeks

Intervention Type

Drug

Intervention Name(s)

Enoxaparin-matching placebo

Intervention Description

Administered as injection

Intervention Type

Drug

Intervention Name(s)

Apixaban-matching placebo

Intervention Description

Administered as oral tablets

Primary Outcome Measure Information:

Title

Description

Time Frame

Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose

Secondary Outcome Measure Information:

Title

Rate of Composite of Adjudicated Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism, and Venous Thromboembolic Event-related Death With Onset During Intended Treatment Period

Description

Time Frame

Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose

Title

Description

VTE=venous thromboembolic event; VTE-related death=combination of fatal or nonfatal PE and symptomatic or asymptomatic DVT. Event rate=Number of events divided by the number of patients evaluated.

Time Frame

Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose

Title

Rate of Major Bleeding, Clinically Relevant Nonmajor Bleeding (CRNM), Major or CRNM, and Any Bleeding During the Treatment Period

Description

Time Frame

First dose of study drug (presurgery) through 2 days after the last dose of study drug

Title

Number of Participants With Serious Adverse Events (SAEs), Bleeding Adverse Events (AEs), and Death as Outcome

Description

Time Frame

First dose of study drug (presurgery) through 30 days after the last dose of study drug

Title

Number of Participants With a Bleeding-related Adverse Event During the Treatment Period

Description

Time Frame

First dose of study drug (presurgery) through 2 days after the last dose of study drug

Title

Number of Participants With a Bleeding-related Adverse Events During the Treatment Period (Continued)

Description

Time Frame

First dose of study drug (presurgery) through 2 days after the last dose of study drug

Title

Number of Participants With a Bleeding-related Adverse Event During the Treatment Period (Continued)

Description

Time Frame

First dose of study drug (presurgery) through 2 days after the last dose of study drug

Title

Number of Participants With Neurologic Adverse Events With Onset During the Treatment Period

Description

Time Frame

First dose of study drug (presurgery) through 2 days after the last dose of study drug

Title

Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period

Description

Time Frame

First dose of study drug (presurgery) through 2 days after the last dose of study drug

Title

Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period (Continued)

Description

Time Frame

First dose of study drug (presurgery) through 2 days after the last dose of study drug

Title

Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period (Continued)

Description

Time Frame

First dose of study drug (presurgery) through 2 days after the last dose of study drug

Title

Number of Participants With Adverse Events Related to Elevations in Liver Function Test Results With Onset During the Treatment Period

Description

Treatment guidelines were provided for jaundice and elevated results of liver function tests.

Time Frame

First dose of study drug (presurgery) through 30 days after the last dose of study drug

Title

Rates of Adjudicated Myocardial Infarction (MI)/Stroke, MI, Stroke, and Thrombocytopenia During the Intended Treatment Period

Description

Time Frame

Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria Patients undergoing elective unilateral total hip replacement or a revision of at least 1 component of a total hip replacement. Patients who were willing and able to undergo bilateral ascending contrast venography Either sex, any race, 18 years and older Key Exclusion Criteria Known or suspected bleeding or coagulation disorder in the patient or his or her first-degree relative Known or suspected history of heparin-induced thrombocytopenia Known coagulopathy Active bleeding or at high risk for bleeding Brain, spinal, ophthalmologic, or major surgery or trauma within the past 90 days Active hepatobiliary disease Alcohol and/or substance abuse within the past year Any condition for which surgery or administration of an anticoagulant is contraindicated Two consecutive blood pressure readings within 15 to 30 minutes with supine systolic blood pressure >180 mm Hg or supine diastolic blood pressure >105 mm Hg Clinically significant laboratory abnormalities at the enrollment visit: Hemoglobin <10 g/dL Platelet count <100,000/mm^3 Creatinine clearance <30 mL/min, as estimated by the method of Cockcroft and Gault Alanine aminotransferase or aspartate aminotransferase >2*upper limit of normal or a total bilirubin ≥ 1.5*1 (unless an alternative causative factor such as Gilbert's syndrome was identified) Need for ongoing treatment with a parenteral or oral anticoagulant (eg, subjects with mechanical valves, warfarin eligible atrial fibrillation) Current use of dextrans or fibrinolytics Treatment with medications affecting coagulation or platelet function

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

35209

Country

United States

Facility Name

West Alabama Research, Llc

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35209

Country

United States

Facility Name

Martin Bowen Hefley Orthopedics

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Orthoarkansas, P.A.

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Uc Davis Medical Center

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

Colorado Orthopedic Consultants, Pc

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80012

Country

United States

Facility Name

Advanced Orthopedic And Sports Medicine Specilists

City

Denver

State/Province

Colorado

ZIP/Postal Code

80230

Country

United States

Facility Name

Denver-Vail Orthopedics, P.C.

City

Denver

State/Province

Colorado

ZIP/Postal Code

80230

Country

United States

Facility Name

Pab Clinical Research

City

Brandon

State/Province

Florida

ZIP/Postal Code

33511

Country

United States

Facility Name

Research Alliance, Inc.

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33756

Country

United States

Facility Name

Shrock Orthopedic Research

City

Ft. Lauderdale

State/Province

Florida

ZIP/Postal Code

33316

Country

United States

Facility Name

Phoenix Clinical Research, Llc

City

Tamarac

State/Province

Florida

ZIP/Postal Code

33321

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

Bosie Orthopedic Clinic

City

Meridian

State/Province

Idaho

ZIP/Postal Code

83642

Country

United States

Facility Name

University Orthopedic Center

City

Altoona

State/Province

Pennsylvania

ZIP/Postal Code

16602

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

C1199ACK

Country

Argentina

Facility Name

Local Institution

City

Capital Federal

State/Province

Buenos Aires

ZIP/Postal Code

C1280AEB

Country

Argentina

Facility Name

Local Institution

City

Capital Federal

State/Province

Buenos Aires

ZIP/Postal Code

C1425AGP

Country

Argentina

Facility Name

Local Institution

City

Ciudad De Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

C1426BOS

Country

Argentina

Facility Name

Local Institution

City

Coronel Suarez

State/Province

Buenos Aires

ZIP/Postal Code

B7540GHD

Country

Argentina

Facility Name

Local Institution

City

Monte Grande

State/Province

Buenos Aires

ZIP/Postal Code

B1842DID

Country

Argentina

Facility Name

Local Institution

City

Camperdown

State/Province

New South Wales

ZIP/Postal Code

2050

Country

Australia

Facility Name

Local Institution

City

Kogarah

State/Province

New South Wales

ZIP/Postal Code

2217

Country

Australia

Facility Name

Local Institution

City

Lismore

State/Province

New South Wales

ZIP/Postal Code

2480

Country

Australia

Facility Name

Local Institution

City

Southport

State/Province

Queensland

ZIP/Postal Code

4215

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

Malvern

State/Province

Victoria

ZIP/Postal Code

3144

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

6000

Country

Australia

Facility Name

Local Institution

City

Antwerp

ZIP/Postal Code

2020

Country

Belgium

Facility Name

Local Institution

City

Brasschaat

ZIP/Postal Code

2930

Country

Belgium

Facility Name

Local Institution

City

Genk

ZIP/Postal Code

3600

Country

Belgium

Facility Name

Local Institution

City

Hasselt

ZIP/Postal Code

3500

Country

Belgium

Facility Name

Local Institution

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Local Institution

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2B7

Country

Canada

Facility Name

Local Institution

City

Ajax

State/Province

Ontario

ZIP/Postal Code

L1S 2J5

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

Guelph

State/Province

Ontario

ZIP/Postal Code

N1E 6L9

Country

Canada

Facility Name

Local Institution

City

Newmarket

State/Province

Ontario

ZIP/Postal Code

L3Y 5G8

Country

Canada

Facility Name

Local Institution

City

Oshawa

State/Province

Ontario

ZIP/Postal Code

L1J 2J2

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

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

Montreal

State/Province

Quebec

ZIP/Postal Code

H3G 1A4

Country

Canada

Facility Name

Local Institution

City

Quebec

ZIP/Postal Code

G1L 3L5

Country

Canada

Facility Name

Local Institution

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100035

Country

China

Facility Name

Local Institution

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100853

Country

China

Facility Name

Local Institution

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510405

Country

China

Facility Name

Local Institution

City

Qingdao

State/Province

Shandong

ZIP/Postal Code

266003

Country

China

Facility Name

Local Institution

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200011

Country

China

Facility Name

Local Institution

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200025

Country

China

Facility Name

Local Institution

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200233

Country

China

Facility Name

Local Institution

City

Amager

ZIP/Postal Code

2300

Country

Denmark

Facility Name

Local Institution

City

Frederiksberg

ZIP/Postal Code

2000

Country

Denmark

Facility Name

Local Institution

City

Herlev

ZIP/Postal Code

2730

Country

Denmark

Facility Name

Local Institution

City

Horsholm

ZIP/Postal Code

2970

Country

Denmark

Facility Name

Local Institution

City

Hvidovre

ZIP/Postal Code

2650

Country

Denmark

Facility Name

Local Institution

City

Kobenhavn Nv

ZIP/Postal Code

2400

Country

Denmark

Facility Name

Local Institution

City

Silkeborg

ZIP/Postal Code

8600

Country

Denmark

Facility Name

Local Institution

City

Nice

ZIP/Postal Code

06200

Country

France

Facility Name

Local Institution

City

Paris

ZIP/Postal Code

75014

Country

France

Facility Name

Local Institution

City

Paris

ZIP/Postal Code

75019

Country

France

Facility Name

Local Institution

City

Paris

ZIP/Postal Code

75679

Country

France

Facility Name

Local Institution

City

Saint Etienne

ZIP/Postal Code

42100

Country

France

Facility Name

Local Institution

City

Saint-Saulve

ZIP/Postal Code

59880

Country

France

Facility Name

Local Institution

City

Frankfurt / Main

ZIP/Postal Code

65929

Country

Germany

Facility Name

Local Institution

City

Frankfurt

ZIP/Postal Code

60528

Country

Germany

Facility Name

Local Institution

City

Rheinfelden

ZIP/Postal Code

79618

Country

Germany

Facility Name

Local Institution

City

Budapest

ZIP/Postal Code

1081

Country

Hungary

Facility Name

Local Institution

City

Kecskemet

ZIP/Postal Code

6000

Country

Hungary

Facility Name

Local Institution

City

Szeged

ZIP/Postal Code

6720

Country

Hungary

Facility Name

Local Institution

City

Szolnok

ZIP/Postal Code

5000

Country

Hungary

Facility Name

Local Institution

City

Ahmedabad

State/Province

Gujarat

ZIP/Postal Code

380015

Country

India

Facility Name

Local Institution

City

Ludhiana

State/Province

Punjab

ZIP/Postal Code

141001

Country

India

Facility Name

Local Institution

City

Lucknow

State/Province

Uttar Prsdesh

ZIP/Postal Code

226003

Country

India

Facility Name

Local Institution

City

Bangalore

ZIP/Postal Code

560034

Country

India

Facility Name

Local Institution

City

Mangalore

ZIP/Postal Code

575001

Country

India

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

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

Mexico City

State/Province

Distrito Federal

ZIP/Postal Code

06726

Country

Mexico

Facility Name

Local Institution

City

Mexico City

State/Province

Distrito Federal

ZIP/Postal Code

07760

Country

Mexico

Facility Name

Local Institution

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

45235

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

Aguascalientes

ZIP/Postal Code

20010

Country

Mexico

Facility Name

Local Institution

City

Chihuahua

ZIP/Postal Code

31020

Country

Mexico

Facility Name

Local Institution

City

Gjettum

ZIP/Postal Code

1346

Country

Norway

Facility Name

Local Institution

City

Kongsvinger

ZIP/Postal Code

2212

Country

Norway

Facility Name

Local Institution

City

Lillehammer

ZIP/Postal Code

2629

Country

Norway

Facility Name

Local Institution

City

Tonsberg

ZIP/Postal Code

3116

Country

Norway

Facility Name

Local Institution

City

Tynset

ZIP/Postal Code

2500

Country

Norway

Facility Name

Local Institution

City

Gdansk

ZIP/Postal Code

80-803

Country

Poland

Facility Name

Local Institution

City

Lodz

ZIP/Postal Code

91-002

Country

Poland

Facility Name

Local Institution

City

Szczecin

ZIP/Postal Code

71-252

Country

Poland

Facility Name

Local Institution

City

Warszawa

ZIP/Postal Code

02-005

Country

Poland

Facility Name

Local Institution

City

Warszawa

ZIP/Postal Code

03-242

Country

Poland

Facility Name

Local Institution

City

Wroclaw

ZIP/Postal Code

50-556

Country

Poland

Facility Name

Local Institution

City

Bucharest

ZIP/Postal Code

021659

Country

Romania

Facility Name

Local Institution

City

Cluj Napoca

ZIP/Postal Code

400132

Country

Romania

Facility Name

Local Institution

City

Chelyabinsk

ZIP/Postal Code

454021

Country

Russian Federation

Facility Name

Local Institution

City

Kazan

ZIP/Postal Code

420029

Country

Russian Federation

Facility Name

Local Institution

City

Moscow

ZIP/Postal Code

111539

Country

Russian Federation

Facility Name

Local Institution

City

Moscow

ZIP/Postal Code

115522

Country

Russian Federation

Facility Name

Local Institution

City

Moscow

ZIP/Postal Code

117292

Country

Russian Federation

Facility Name

Local Institution

City

Moscow

ZIP/Postal Code

119415

Country

Russian Federation

Facility Name

Local Institution

City

Saint Petersburg

ZIP/Postal Code

193312

Country

Russian Federation

Facility Name

Local Institution

City

Saint Petersburg

ZIP/Postal Code

194354

Country

Russian Federation

Facility Name

Local Institution

City

Saint Petersburg

ZIP/Postal Code

195427

Country

Russian Federation

Facility Name

Local Institution

City

Saint Petersburg

ZIP/Postal Code

196247

Country

Russian Federation

Facility Name

Local Institution

City

Saint Petersburg

ZIP/Postal Code

199106

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

192242

Country

Russian Federation

Facility Name

Local Institution

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

Facility Name

Local Institution

City

Badalona-Barcelone

ZIP/Postal Code

08916

Country

Spain

Facility Name

Local Institution

City

Barcelona

ZIP/Postal Code

08006

Country

Spain

Facility Name

Local Institution

City

Barcelona

ZIP/Postal Code

08024

Country

Spain

Facility Name

Local Institution

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Local Institution

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Local Institution

City

Gothenburg

ZIP/Postal Code

416 85

Country

Sweden

Facility Name

Local Institution

City

Stockholm

ZIP/Postal Code

182 88

Country

Sweden

Facility Name

Local Institution

City

Cherkassy

ZIP/Postal Code

18009

Country

Ukraine

Facility Name

Local Institution

City

Chernivtsy

ZIP/Postal Code

58013

Country

Ukraine

Facility Name

Local Institution

City

Dnipropetrovsk

ZIP/Postal Code

49005

Country

Ukraine

Facility Name

Local Institution

City

Ivano-Frankivsk

ZIP/Postal Code

76008

Country

Ukraine

Facility Name

Local Institution

City

Kyiv

ZIP/Postal Code

01601

Country

Ukraine

Facility Name

Local Institution

City

Kyiv

ZIP/Postal Code

04107

Country

Ukraine

Facility Name

Local Institution

City

Sevastopol

ZIP/Postal Code

99018

Country

Ukraine

Facility Name

Local Institution

City

London

State/Province

Greater London

ZIP/Postal Code

SE5 9RS

Country

United Kingdom

Facility Name

Local Institution

City

Wigan

State/Province

Lancashire

ZIP/Postal Code

WN6 9EP

Country

United Kingdom

Facility Name

Local Institution

City

Epsom

State/Province

Surrey

ZIP/Postal Code

KT18 7EG

Country

United Kingdom

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

23279103

Citation

Pineo GF, Gallus AS, Raskob GE, Chen D, Ramirez LM, Ramacciotti E, Lassen MR, Wang L. Apixaban after hip or knee arthroplasty versus enoxaparin: efficacy and safety in key clinical subgroups. J Thromb Haemost. 2013 Mar;11(3):444-51. doi: 10.1111/jth.12109.

Results Reference

derived

PubMed Identifier

21175312

Citation

Lassen MR, Gallus A, Raskob GE, Pineo G, Chen D, Ramirez LM; ADVANCE-3 Investigators. Apixaban versus enoxaparin for thromboprophylaxis after hip replacement. N Engl J Med. 2010 Dec 23;363(26):2487-98. doi: 10.1056/NEJMoa1006885.

Results Reference

derived

Learn more about this trial

Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Hip Replacement Surgery (ADVANCE-3)

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Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Hip Replacement Surgery (ADVANCE-3)

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