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Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery (ADVANCE-2)

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 treatment 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

Patients scheduled for either elective unilateral or same-day bilateral total knee replacement surgery (TKR) or a revision of at least 1 component of a TKR
Patients willing and able to undergo bilateral ascending contrast venography

Key Exclusion Criteria

Known or suspected hereditary or acquired bleeding or coagulation disorders in the participant 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, in the opinion of the investigator, surgery or administration of an anticoagulant was 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 level >2*upper limit of normal (ULN) or a total bilirubin ≥1.5*ULN (unless an alternative causative factor such as Gilbert's syndrome was identified)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Apixaban, 2.5 mg BID + Placebo

Enoxaparin, 40 mg QD + Placebo

Arm Description

Participants received apixaban, 2.5-mg tablets twice daily (BID), plus a matching enoxaparin-placebo injection 12 (±3) hours prior to hip-replacement surgery through 11 (±2) days after the day of surgery.

Participants received enoxaparin, 40-mg subcutaneous injection once daily (QD), plus a matching apixaban-placebo tablet 12 (±3) hours prior to hip-replacement surgery through 11 (±2) days after the day of surgery.

Outcomes

Primary Outcome Measures

Rate of Adjudicated Venous Thromboembolic Event-related and All-cause Deaths With Onset During the Intended-treatment Period

Event rate=Number of events divided by the number of patients evaluated. Intended treatment period starts on the day of randomization, and for those who received study drug, ends at the later of 2 days after last dose or 14 days after the first dose of study drug; for randomized patients who did not receive study drug, the period ends 14 days after randomization.Venous thromboembolic event (VTE)=nonfatal pulmonary embolism (PE), symptomatic deep vein thrombosis (DVT), or asymptomatic proximal DVT detected by ultrasound. VTE-related death=fatal PE or sudden death for which VTE could not be excluded as a cause.

Secondary Outcome Measures

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

Event rate=Number of events divided by the number of patients evaluated. Intended treatment period starts on the day of randomization, and for those who received study drug, ends at the later of 2 days after last dose or 14 days after the first dose of study drug; for randomized patients who did not receive study drug, the period ends 14 days after randomization; for randomized patients who did not receive study drug, the period ends 14 days after randomization. Venous thromboembolic event (VTE)=nonfatal pulmonary embolism (PE), symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death=fatal PE or sudden death for which VTE could not be excluded as a cause.

Rate of Major Bleeding, Clinically Relevant Nonmajor Bleeding (CRNM), and Major Bleeding or CRNM

Event rate=Number of events divided by number of patients evaluated. Adjusted difference of event rates takes into consideration type of surgery as a stratification factor. Bleeding Criteria: Major bleeding=an event consisting of clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more and/or a transfusion of 2 or more units of packed red blood cells; bleeding that occurred in at least 1 of the following critical sites: intracranial, intraspinal, intraocular (within the corpus of the eye; a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, and retroperitoneal; bleeding that was fatal. CRNM bleeding= clinically overt bleeding; that satisfies none of the additional criteria required for the event to be adjudicated as a major bleeding event; that led to either hospital admission for bleeding, physician-guided medical or surgical treatment for bleeding; or a change in antithrombic treatment.

Number of Participants With Serious Adverse Events (SAE), Bleeding Adverse Events (AEs), Discontinuations Due to 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. Bleeding AEs=all serious or nonserious bleeding-related AEs.

Full Information

NCT ID

NCT00452530

First Posted

March 23, 2007

Last Updated

July 8, 2014

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT00452530

Brief Title

Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery

Acronym

ADVANCE-2

Official Title

A Phase 3, Randomized, Double-blind, Active-controlled (Enoxaparin 40 mg QD), Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Apixaban in Subjects Undergoing Elective Total Knee Replacement Surgery (The ADVANCE - 2 Study)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

June 2007 (undefined)

Primary Completion Date

January 2009 (Actual)

Study Completion Date

January 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 prevents the development of blood clots in the leg (deep vein thrombosis) and lung (pulmonary embolism), which sometimes occur after knee replacement surgery, and to compare the efficacy of apixaban with that of enoxaparin (Lovenox®) in the prevention of 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

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

3221 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Apixaban, 2.5 mg BID + Placebo

Arm Type

Experimental

Arm Description

Arm Title

Enoxaparin, 40 mg QD + Placebo

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Enoxaparin

Other Intervention Name(s)

Lovenox®

Intervention Description

40 mg, administered once daily by subcutaneous injection, for 12 days

Intervention Type

Drug

Intervention Name(s)

Apixaban

Other Intervention Name(s)

BMS-562247

Intervention Description

2.5 mg, administered twice daily as tablets, for 12 days

Intervention Type

Drug

Intervention Name(s)

Enoxaparin-matching placebo

Intervention Description

Administered once daily by subcutaneous injection

Intervention Type

Drug

Intervention Name(s)

Apixaban-matching placebo

Intervention Description

Oral tablet administered twice daily

Primary Outcome Measure Information:

Title

Rate of Adjudicated Venous Thromboembolic Event-related and All-cause Deaths With Onset During the Intended-treatment Period

Description

Time Frame

Day of randomization to later of 2 days after last dose or 14 days after first dose; 14 days after randomization for those who did not receive study drug

Secondary Outcome Measure Information:

Title

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

Description

Event rate=Number of events divided by the number of patients evaluated. Intended treatment period starts on the day of randomization, and for those who received study drug, ends at the later of 2 days after last dose or 14 days after the first dose of study drug; for randomized patients who did not receive study drug, the period ends 14 days after randomization; for randomized patients who did not receive study drug, the period ends 14 days after randomization. Venous thromboembolic event (VTE)=nonfatal pulmonary embolism (PE), symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death=fatal PE or sudden death for which VTE could not be excluded as a cause.

Time Frame

Day of randomization to later of 2 days after last dose or 14 days after first dose; 14 days after randomization for those who did not receive study

Title

Rate of Major Bleeding, Clinically Relevant Nonmajor Bleeding (CRNM), and Major Bleeding or CRNM

Description

Time Frame

Days 1 to 12

Title

Number of Participants With Serious Adverse Events (SAE), Bleeding Adverse Events (AEs), Discontinuations Due to AEs, and Death as Outcome

Description

Time Frame

Days 1 through 12 + 2 days (nonserious AEs, bleeding AES) or 30 days (SAES, deaths) after last dose of study drug

Other Pre-specified Outcome Measures:

Title

Summary of Laboratory Marked Abnormalities on Hematology and Liver and Kidney Function Test Results During the Treatment Period (Patients With Available Measurements)

Description

preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal; abs=absolute. Hemoglobin (g/dL): >2 decrease from preRx value or value <=8; hematocrit (%): <0.75*preRx; platelets: <100*10^9 cells/L; erythrocytes (*10^6 cells/μL): <0.75*preRx; leukocytes: <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; abs basophils: >400/mm^3; abs eosinophils: > 0.750*10^3 cells/µL; abs lymphocytes: <0.750*10*3 cells/ µL or >7.50*10^3 c/ µL; abs monocytes > 2000/mm^3; abs neutrophils: <1.0*10^3 cells/μL; ALP (U/L): >2*ULN; ALT, AST (U/L): >3*ULN; U/L; bilirubin, direct (mg/dL): >1.5*ULN; bilirubin, total (mg/dL): >2*ULN; BUN (mg/dL): >2*ULN; creatinine (mg/dL): >1.5*ULN.

Time Frame

Randomization to Days 2, 3, 4, and 12 (±2 days) and at Days 42 and 72 (±5 days) of follow-up

Title

Summary of Laboratory Marked Abnormalities in Electrolyte and Other Clinical Test Results During the Treatment Period (Patients With Available Measurements)

Description

preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal. Calcium, total (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, serum (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, serum (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, serum (mEq/L): <0.95*LLN or >1.05*ULN, or if preRx <LLN use <0.95*preRx or >ULN if preRx>ULN use >1.05*preRx or <LLN; protein, total (g/dL): <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; CK (U/L): >5*ULN; uric acid (mg/dL): >1.5*ULN, or if preRx >ULN use >2*preRx; glucose, fasting serum (mg/dL): <0.8*LLN or >1.5*ULN, or if preRx <LLN use <0.8*preRx or >ULN.

Time Frame

Randomization to Days 2, 3, 4, and 12 (±2 days) and at Days 42 and 72 (±5 days) of follow-up

Title

Summary of Laboratory Marked Abnormalities in Urinalysis Results During the Treatment Period-Treated Subjects With Available Measurements (Urinalysis)

Description

preRX=pretreatment. 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 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; protein, 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; Red blood cells , 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; white blood cells, 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.

Time Frame

Randomization to Days 2, 3, 4, and 12 (±2 days) and at Days 42 and 72 (± 5 days) of follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria Patients scheduled for either elective unilateral or same-day bilateral total knee replacement surgery (TKR) or a revision of at least 1 component of a TKR Patients willing and able to undergo bilateral ascending contrast venography Key Exclusion Criteria Known or suspected hereditary or acquired bleeding or coagulation disorders in the participant 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, in the opinion of the investigator, surgery or administration of an anticoagulant was 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 level >2*upper limit of normal (ULN) or a total bilirubin ≥1.5*ULN (unless an alternative causative factor such as Gilbert's syndrome was identified)

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

Local Institution

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Local Institution

City

Innsbruck

ZIP/Postal Code

6020

Country

Austria

Facility Name

Local Institution

City

Linz

ZIP/Postal Code

4010

Country

Austria

Facility Name

Local Institution

City

Wels

ZIP/Postal Code

4600

Country

Austria

Facility Name

Local Institution

City

Wiener Neustadt

ZIP/Postal Code

2700

Country

Austria

Facility Name

Local Institution

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Local Institution

City

Wien

ZIP/Postal Code

1130

Country

Austria

Facility Name

Local Institution

City

Antwerpen

ZIP/Postal Code

2020

Country

Belgium

Facility Name

Local Institution

City

Hasselt

ZIP/Postal Code

3500

Country

Belgium

Facility Name

Local Institution

City

Belo Horizonte - Mg

State/Province

Minas Gerais

ZIP/Postal Code

30130

Country

Brazil

Facility Name

Local Institution

City

Sao Paulo

ZIP/Postal Code

04023

Country

Brazil

Facility Name

Local Institution

City

Santiago

State/Province

Metropolitana

ZIP/Postal Code

7500922

Country

Chile

Facility Name

Local Institution

City

Santiago

State/Province

Metropolitana

ZIP/Postal Code

8330033

Country

Chile

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

100835

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

Bogota

ZIP/Postal Code

XXXXX

Country

Colombia

Facility Name

Local Institution

City

Bogota

Country

Colombia

Facility Name

Local Institution

City

Cali

ZIP/Postal Code

- - - - -

Country

Colombia

Facility Name

Local Institution

City

Medelin

Country

Colombia

Facility Name

Local Institution

City

Brno

ZIP/Postal Code

662 50

Country

Czech Republic

Facility Name

Local Institution

City

Chomutov

ZIP/Postal Code

430 12

Country

Czech Republic

Facility Name

Local Institution

City

Pardubice

ZIP/Postal Code

532 03

Country

Czech Republic

Facility Name

Local Institution

City

Prague 8

ZIP/Postal Code

180 81

Country

Czech Republic

Facility Name

Local Institution

City

Uherske Hradiste

ZIP/Postal Code

686 68

Country

Czech Republic

Facility Name

Local Institution

City

Hellerup

ZIP/Postal Code

2900

Country

Denmark

Facility Name

Local Institution

City

Hvidovre

ZIP/Postal Code

2650

Country

Denmark

Facility Name

Local Institution

City

Kolding

ZIP/Postal Code

6000

Country

Denmark

Facility Name

Local Institution

City

Viborg

ZIP/Postal Code

8800

Country

Denmark

Facility Name

Local Institution

City

Monaco

ZIP/Postal Code

98000

Country

France

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-Saulve

ZIP/Postal Code

59880

Country

France

Facility Name

Local Institution

City

Bad Mergentheim

ZIP/Postal Code

97980

Country

Germany

Facility Name

Local Institution

City

Bochum

ZIP/Postal Code

44791

Country

Germany

Facility Name

Local Institution

City

Brandenburg

ZIP/Postal Code

14770

Country

Germany

Facility Name

Local Institution

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Local Institution

City

Frankfurt Am Main

ZIP/Postal Code

60528

Country

Germany

Facility Name

Local Institution

City

Frankfurt

ZIP/Postal Code

65929

Country

Germany

Facility Name

Local Institution

City

Halle/S

ZIP/Postal Code

06112

Country

Germany

Facility Name

Local Institution

City

Kremmen Ot Sommerfeld

ZIP/Postal Code

16766

Country

Germany

Facility Name

Local Institution

City

Rheinfelden

ZIP/Postal Code

79618

Country

Germany

Facility Name

Local Institution

City

Witten

ZIP/Postal Code

58455

Country

Germany

Facility Name

Local Institution

City

Szeged

ZIP/Postal Code

6725

Country

Hungary

Facility Name

Local Institution

City

Szekszard

ZIP/Postal Code

7100

Country

Hungary

Facility Name

Local Institution

City

Ahmedabad

State/Province

Gujarat

ZIP/Postal Code

380054

Country

India

Facility Name

Local Institution

City

Ludhiana

State/Province

Punjab

ZIP/Postal Code

141001

Country

India

Facility Name

Local Institution

City

Bangalore

ZIP/Postal Code

560034

Country

India

Facility Name

Local Institution

City

Baroda

ZIP/Postal Code

390007

Country

India

Facility Name

Local Institution

City

Mangalore

ZIP/Postal Code

575001

Country

India

Facility Name

Local Institution

City

Jeruselem

ZIP/Postal Code

91031

Country

Israel

Facility Name

Local Institution

City

Petach-Tikva

ZIP/Postal Code

49372

Country

Israel

Facility Name

Local Institution

City

Safed

ZIP/Postal Code

13110

Country

Israel

Facility Name

Local Institution

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

Local Institution

City

Tel Hashomer

ZIP/Postal Code

52621

Country

Israel

Facility Name

Local Institution

City

Abano Terme (Pd)

ZIP/Postal Code

35031

Country

Italy

Facility Name

Local Institution

City

Bologna

ZIP/Postal Code

40136

Country

Italy

Facility Name

Local Institution

City

Pordenone

ZIP/Postal Code

33170

Country

Italy

Facility Name

Local Institution

City

Roma

ZIP/Postal Code

00168

Country

Italy

Facility Name

Local Institution

City

San Donato Milanese (Mi)

ZIP/Postal Code

20097

Country

Italy

Facility Name

Local Institution

City

Jeonnam

ZIP/Postal Code

519-809

Country

Korea, Republic of

Facility Name

Local Institution

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

Facility Name

Local Institution

City

Seoul

ZIP/Postal Code

136-705

Country

Korea, Republic of

Facility Name

Local Institution

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

Facility Name

Local Institution

City

Kuala Lumpur

ZIP/Postal Code

50586

Country

Malaysia

Facility Name

Local Institution

City

Kuala Lumpur

ZIP/Postal Code

56000

Country

Malaysia

Facility Name

Local Institution

City

Zapopan

State/Province

Jalisco

ZIP/Postal Code

45200

Country

Mexico

Facility Name

Local Institution

City

Hermosillo

State/Province

Sonora

ZIP/Postal Code

83190

Country

Mexico

Facility Name

Local Institution

City

Aguascalientes

ZIP/Postal Code

20010

Country

Mexico

Facility Name

Local Institution

City

San Luis Potosi

ZIP/Postal Code

78340

Country

Mexico

Facility Name

Local Institution

City

Veracruz

ZIP/Postal Code

91700

Country

Mexico

Facility Name

Local Institution

City

Alesund

ZIP/Postal Code

6026

Country

Norway

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

Manila

ZIP/Postal Code

1000

Country

Philippines

Facility Name

Local Institution

City

Quezon City

ZIP/Postal Code

1102

Country

Philippines

Facility Name

Local Institution

City

Quezon City

ZIP/Postal Code

1114

Country

Philippines

Facility Name

Local Institution

City

Bytom

ZIP/Postal Code

41-902

Country

Poland

Facility Name

Local Institution

City

Gdansk

ZIP/Postal Code

80-803

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

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

Lipetsk

ZIP/Postal Code

398035

Country

Russian Federation

Facility Name

Local Institution

City

Moscow

ZIP/Postal Code

115522

Country

Russian Federation

Facility Name

Local Institution

City

Rostov-Na-Donu

ZIP/Postal Code

344010

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

199106

Country

Russian Federation

Facility Name

Local Institution

City

Samara

ZIP/Postal Code

443095

Country

Russian Federation

Facility Name

Local Institution

City

Singapore

ZIP/Postal Code

169608

Country

Singapore

Facility Name

Local Institution

City

Singapore

ZIP/Postal Code

529889

Country

Singapore

Facility Name

Local Institution

City

Randburg

State/Province

Free State

ZIP/Postal Code

2194

Country

South Africa

Facility Name

Local Institution

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

2031

Country

South Africa

Facility Name

Local Institution

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

2193

Country

South Africa

Facility Name

Local Institution

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

0083

Country

South Africa

Facility Name

Local Institution

City

Somerset West

State/Province

Western Cape

ZIP/Postal Code

7130

Country

South Africa

Facility Name

Local Institution

City

Tygerberg

State/Province

Western Cape

ZIP/Postal Code

7505

Country

South Africa

Facility Name

Local Institution

City

Worcester

State/Province

Western Cape

ZIP/Postal Code

6850

Country

South Africa

Facility Name

Local Institution

City

Badalona-Barcelona

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

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Local Institution

City

Santiago De Compostela

ZIP/Postal Code

15706

Country

Spain

Facility Name

Local Institution

City

Valencia

ZIP/Postal Code

46010

Country

Spain

Facility Name

Local Institution

City

Boras

ZIP/Postal Code

501 82

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 9PJ

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

20206776

Citation

Lassen MR, Raskob GE, Gallus A, Pineo G, Chen D, Hornick P; ADVANCE-2 investigators. Apixaban versus enoxaparin for thromboprophylaxis after knee replacement (ADVANCE-2): a randomised double-blind trial. Lancet. 2010 Mar 6;375(9717):807-15. doi: 10.1016/S0140-6736(09)62125-5.

Results Reference

derived

Learn more about this trial

Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery

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Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery (ADVANCE-2)

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