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

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

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.

Study Overview

• Status: Completed
• Conditions: Deep Vein Thrombosis; Pulmonary Embolism
• Intervention / Treatment: Drug: Enoxaparin + Placebo; Drug: Apixaban + Placebo

• Study Type: Interventional
• Enrollment (Actual): 3608
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1425
    • Local Institution
  • Buenos Aires, Argentina, C1181
    • Local Institution
  • Buenos Aires, Argentina, 1280
    • Local Institution
  • Buenos Aires, Argentina, 7540
    • Local Institution
  • Cordoba, Argentina, 5000
    • Local Institution
  • Buenos Aires
    • Capital Federal, Buenos Aires, Argentina, 1426
      • Local Institution
    • Capital Federal, Buenos Aires, Argentina, 1012
      • Local Institution
• Australia
  • Australian Capital Territory
    • Garran, Australian Capital Territory, Australia, 2605
      • Local Institution
  • New South Wales
    • Camperdown, New South Wales, Australia, NSW 2050
      • Local Institution
    • Caringbah, New South Wales, Australia, 2229
      • Local Institution
    • Lismore, New South Wales, Australia, 2480
      • Local Institution
  • Queensland
    • Gold Coast, Queensland, Australia, 4215
      • Local Institution
  • South Australia
    • Adelaide, South Australia, Australia, 5011
      • Local Institution
    • Bedford Park, South Australia, Australia, 5042
      • Local Institution
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Local Institution
    • Windsor, Victoria, Australia, 3181
      • Local Institution
  • Western Australia
    • Perth, Western Australia, Australia, 6001
      • Local Institution
• Brazil
  • Sao Paulo, Brazil, 05403
    • Local Institution
  • Parana
    • Curitiba, Parana, Brazil, 80060
      • Local Institution
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035
      • Local Institution
    • Porto Alegre, Rs, Rio Grande Do Sul, Brazil, 90020
      • Local Institution
  • Sao Paulo
    • Campinas, Sao Paulo, Brazil, 13083
      • Local Institution
• Canada
  • Quebec, Canada, G1L 3L5
    • Local Institution
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2R7
      • Local Institution
  • Ontario
    • Ajax, Ontario, Canada, L1S 2J5
      • Local Institution
    • Burlington, Ontario, Canada, L7R 4B7
      • Local Institution
    • Cambridge, Ontario, Canada, N1R 7L7
      • Local Institution
    • Chatham, Ontario, Canada, N7L 4T1
      • Local Institution
    • Dartmouth, Ontario, Canada, B2Y 2N6
      • Local Institution
    • Guelph, Ontario, Canada, N1E 6L9
      • Local Institution
    • Lindsay, Ontario, Canada, K9V 4M8
      • Local Institution
    • Newmarket, Ontario, Canada, L3Y 5G8
      • Local Institution
    • Niagara Falls, Ontario, Canada, L2E 6X2
      • Local Institution
    • Sarnia, Ontario, Canada, N7T 6H3
      • Local Institution
    • Scarborough, Ontario, Canada, M1S 4T7
      • Local Institution
    • Scarborough, Ontario, Canada, M3C 1W3
      • Local Institution
    • St. Catharines, Ontario, Canada, L2R 7P3
      • Local Institution
    • Stratford, Ontario, Canada, N5A 2N4
      • Local Institution
    • Waterloo, Ontario, Canada, N2J 1C4
      • Local Institution
    • Windsor, Ontario, Canada, N8W 1E6
      • Local Institution
  • Prince Edward Island
    • Charlottetown, Prince Edward Island, Canada, C1A 1L2
      • Local Institution
  • Quebec
    • Montreal, Quebec, Canada, H4J 1C5
      • Local Institution
• Denmark
  • Horsholm, Denmark, 2970
    • Local Institution
  • Kopenhamn S, Denmark, 2300
    • Local Institution
• Hungary
  • Kecskemet, Hungary, 6000
    • Local Institution
  • Szekesfehervar, Hungary, 8000
    • Local Institution
  • Szolnok, Hungary, 5008
    • Local Institution
• Israel
  • Afula, Israel, 18101
    • Local Institution
  • Beer-Sheva, Israel, 84101
    • Local Institution
  • Haifa, Israel, 31096
    • Local Institution
  • Holon, Israel, 58100
    • Local Institution
  • Kfar-Saba, Israel, 44281
    • Local Institution
  • Petach-Tikva, Israel, 49100
    • Local Institution
  • Rehovot, Israel, 76100
    • Local Institution
  • Zerifin, Israel, 70300
    • Local Institution
• Mexico
  • Chihuahua, Mexico, 31000
    • Local Institution
  • Baja California
    • Tijuana, Baja California, Mexico, 22010
      • Local Institution
  • Distrito Federal
    • Df, Distrito Federal, Mexico, 01030
      • Local Institution
    • Df, Distrito Federal, Mexico, 05300
      • Local Institution
    • Df, Distrito Federal, Mexico, 07760
      • Local Institution
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44280
      • Local Institution
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64460
      • Local Institution
    • Monterrey, Nuevo Leon, Mexico, 64000
      • Local Institution
  • Tamaulipas
    • Cd Madero, Tamaulipas, Mexico, 89240
      • Local Institution
  • Veracruz
    • Jalapa, Veracruz, Mexico, 91020
      • Local Institution
  • Yucatan
    • Merida, Yucatan, Mexico, 97070
      • Local Institution
    • Merida, Yucatan, Mexico, 97133
      • Local Institution
• Poland
  • Bialystok, Poland, 15276
    • Local Institution
  • Krakow, Poland, 31-826
    • Local Institution
  • Lodz, Poland, 91002
    • Local Institution
  • Lublin, Poland, 20954
    • Local Institution
  • Szczecin, Poland, 71252
    • Local Institution
  • Warszawa, Poland, 00909
    • Local Institution
  • Warszawa, Poland, 02005
    • Local Institution
• Russian Federation
  • Moscow, Russian Federation, 117333
    • Local Institution
  • Samara, Russian Federation, 443095
    • Local Institution
  • St. Petersburg, Russian Federation, 195257
    • Local Institution
• Sweden
  • Goteborg, Sweden, 416 85
    • Local Institution
• Turkey
  • Adana, Turkey, 01330
    • Local Institution
  • Bursa, Turkey, 16059
    • Local Institution
  • Mersin, Turkey, 33163
    • Local Institution
  • Trabzon, Turkey, 61030
    • Local Institution
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Capstone Clinical Trials, Inc
    • Birmingham, Alabama, United States, 35205
      • Capstone Clinical Trials, Inc
    • Tuscaloosa, Alabama, United States, 35406
      • West Alabama Research, Inc.
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Martin Bowen Hefley Orthopedics
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Colorado Orthopedic Consultants, PC
    • Denver, Colorado, United States, 80210
      • Colorado Joint Replacement
    • Denver, Colorado, United States, 80230
      • Jdpmedical Research
    • Englewood, Colorado, United States, 80113
      • Orhtopaedic Physicians Of Colorado, P.C.
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Orthopedics Assocs Of Hartford
  • District of Columbia
    • Washington, District of Columbia, United States, 20006
      • Anthony S. Unger, Md
  • Florida
    • Bay Pines, Florida, United States, 33744
      • Bay Pines VA Medical Center
    • Brandon, Florida, United States, 33511
      • PAB Clinical Research
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Center for Clinical Research
    • Orange City, Florida, United States, 32763
      • Mark W. Hollmann, Md
    • Winter Park, Florida, United States, 32789
      • Jewett Orthopaedic Clinic
  • Georgia
    • Decatur, Georgia, United States, 30033
      • Atlanta Knee And Sports Medicine
  • Idaho
    • Boise, Idaho, United States, 83702
      • Intermountain Orthopaedics
    • Boise, Idaho, United States, 83702
      • Americana Orthopedics
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Bluegrass Orthopaedics/Bmr
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Charleston Orthopaedic Assocs.
  • Texas
    • Houston, Texas, United States, 77030
      • Bone & Joint Clinic Of Houston
    • Houston, Texas, United States, 77025
      • Kelsey Seybold Clinic
    • Lubbock, Texas, United States, 79410
      • Gill Orthopedic Center
    • Lubbock, Texas, United States, 79410
      • Robert R. King, Md
    • San Antonio, Texas, United States, 78217
      • Unlimited Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A1; + placebo	Drug: Enoxaparin + Placebo; Syringes + tablets, Subcutaneous + Oral, 30mg, twice daily, 12 day treatment period; Other Names: Lovenox®
Experimental: A2; + placebo	Drug: Apixaban + Placebo; Tablet + Syringes, Oral + subcutaneous, 2.5 mg, twice daily, 12 day treatment period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From Day 1 or Day 2 to last dose, plus 2 days or 14 days post 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.	First dose of study drug to last dose, plus 2 days post last dose
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.	Last dose of study drug to Day 72 (60 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 (%).	From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
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 (%).	From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
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 (%).	From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
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 (%).	From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
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 (%).	From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
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 (%).	From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
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 (%).	From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
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 (%).	From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
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 (%).	From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
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 (%).	From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
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 (%).	From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
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 (%).	From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
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 (%).	From first dose to last dose, plus 2 days (12 days, plus 2)
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.	Post last dose of study drug to Day 72 (60 days)
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.	First dose to last dose, plus 2 days for AEs (12 + 2 days) or plus 30 days for SAEs (12 + 30 days)
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).	Baseline to last dose of study drug, plus 2 days
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).	Baseline to last dose of study drug, plus 2 days
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.	First dose to last dose of study drug (12 days), plus 2 days
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.	First dose to last dose of study drug (12 days), plus 2 days
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.	First dose to last dose of study drug (12 days), plus 2 days
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.	First dose to last dose of study drug (12 days), plus 2 days

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: August 30, 2006
• First Submitted That Met QC Criteria: September 1, 2006
• First Posted (Estimate): September 4, 2006

Study Record Updates

• Last Update Posted (Estimate): December 30, 2015
• Last Update Submitted That Met QC Criteria: November 25, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Prevention of deep vein thrombosis and pulmonary embolism after total knee replacement surgery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Thrombosis; Venous Thrombosis; Pulmonary Embolism; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Apixaban; Enoxaparin
• Other Study ID Numbers: CV185-034