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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00423319
First received: January 17, 2007
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Deep Vein Thrombosis
Pulmonary Embolism
Drug: Enoxaparin
Drug: Apixaban
Drug: Enoxaparin-matching placebo
Drug: Apixaban-matching placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
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)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

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 [ Time Frame: Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: First dose of study drug (presurgery) through 2 days after the last dose of study drug ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: First dose of study drug (presurgery) through 30 days after the last dose of study drug ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: First dose of study drug (presurgery) through 2 days after the last dose of study drug ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: First dose of study drug (presurgery) through 2 days after the last dose of study drug ] [ Designated as safety issue: Yes ]
    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 Event During the Treatment Period (Continued) [ Time Frame: First dose of study drug (presurgery) through 2 days after the last dose of study drug ] [ Designated as safety issue: Yes ]
    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 Neurologic Adverse Events With Onset During the Treatment Period [ Time Frame: First dose of study drug (presurgery) through 2 days after the last dose of study drug ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: First dose of study drug (presurgery) through 2 days after the last dose of study drug ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: First dose of study drug (presurgery) through 2 days after the last dose of study drug ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: First dose of study drug (presurgery) through 2 days after the last dose of study drug ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: First dose of study drug (presurgery) through 30 days after the last dose of study drug ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 5407
Study Start Date: March 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Apixaban, 2.5 mg BID plus placebo
Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
Drug: Apixaban
Oral tablets, 2.5 mg, twice daily, 5weeks
Other Names:
  • BMS-562247
  • Eliquis®
Drug: Enoxaparin-matching placebo
Administered as injection
Experimental: Enoxaparin, 40 mg QD plus placebo
Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
Drug: Enoxaparin
Subcutaneous, 40 mg, once daily, 5 weeks
Other Name: Lovenox®
Drug: Apixaban-matching placebo
Administered as oral tablets

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00423319

  Hide Study Locations
Locations
United States, Alabama
Capstone Clinical Trials, Inc
Birmingham, Alabama, United States, 35209
West Alabama Research, Llc
Birmingham, Alabama, United States, 35209
United States, Arkansas
Martin Bowen Hefley Orthopedics
Little Rock, Arkansas, United States, 72205
Orthoarkansas, P.A.
Little Rock, Arkansas, United States, 72205
United States, California
Uc Davis Medical Center
Sacramento, California, United States, 95817
United States, Colorado
Colorado Orthopedic Consultants, Pc
Aurora, Colorado, United States, 80012
Advanced Orthopedic And Sports Medicine Specilists
Denver, Colorado, United States, 80230
Denver-Vail Orthopedics, P.C.
Denver, Colorado, United States, 80230
United States, Florida
Pab Clinical Research
Brandon, Florida, United States, 33511
Research Alliance, Inc.
Clearwater, Florida, United States, 33756
Shrock Orthopedic Research
Ft. Lauderdale, Florida, United States, 33316
Phoenix Clinical Research, Llc
Tamarac, Florida, United States, 33321
United States, Georgia
Atlanta Knee And Sports Medicine
Decatur, Georgia, United States, 30033
United States, Idaho
Americana Orthopedics
Boise, Idaho, United States, 83702
Bosie Orthopedic Clinic
Meridian, Idaho, United States, 83642
United States, Pennsylvania
University Orthopedic Center
Altoona, Pennsylvania, United States, 16602
United States, Texas
Robert R. King, Md
Lubbock, Texas, United States, 79410
Gill Orthopedic Center
Lubbock, Texas, United States, 79410
Unlimited Research
San Antonio, Texas, United States, 78217
Argentina
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Capital Federal, Buenos Aires, Argentina, C1280AEB
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Capital Federal, Buenos Aires, Argentina, C1425AGP
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Capital Federal, Buenos Aires, Argentina, C1199ACK
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Ciudad De Buenos Aires, Buenos Aires, Argentina, C1426BOS
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Coronel Suarez, Buenos Aires, Argentina, B7540GHD
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Monte Grande, Buenos Aires, Argentina, B1842DID
Australia, New South Wales
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Camperdown, New South Wales, Australia, 2050
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Kogarah, New South Wales, Australia, 2217
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Lismore, New South Wales, Australia, 2480
Australia, Queensland
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Southport, Queensland, Australia, 4215
Australia, South Australia
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Bedford Park, South Australia, Australia, 5042
Australia, Victoria
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Box Hill, Victoria, Australia, 3128
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Malvern, Victoria, Australia, 3144
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Windsor, Victoria, Australia, 3181
Australia, Western Australia
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Perth, Western Australia, Australia, 6000
Belgium
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Antwerp, Belgium, 2020
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Brasschaat, Belgium, 2930
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Genk, Belgium, 3600
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Hasselt, Belgium, 3500
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Leuven, Belgium, 3000
Canada, Alberta
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Edmonton, Alberta, Canada, T6G 2B7
Canada, Ontario
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Ajax, Ontario, Canada, L1S 2J5
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Cambridge, Ontario, Canada, N1R 7L7
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Chatham, Ontario, Canada, N7L 4T1
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Guelph, Ontario, Canada, N1E 6L9
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Newmarket, Ontario, Canada, L3Y 5G8
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Oshawa, Ontario, Canada, L1J 2J2
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Sarnia, Ontario, Canada, N7T 6H3
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Scarborough, Ontario, Canada, M1S 4T7
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St. Catharines, Ontario, Canada, L2R 7P3
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Stratford, Ontario, Canada, N5A 2N4
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Waterloo, Ontario, Canada, N2J 1C4
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Windsor, Ontario, Canada, N8W 1E6
Canada, Quebec
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Montreal, Quebec, Canada, H3G 1A4
Canada
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Quebec, Canada, G1L 3L5
China, Beijing
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Beijing, Beijing, China, 100853
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Beijing, Beijing, China, 100035
China, Guangdong
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Guangzhou, Guangdong, China, 510405
China, Shandong
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Qingdao, Shandong, China, 266003
China, Shanghai
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Shanghai, Shanghai, China, 200025
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Shanghai, Shanghai, China, 200233
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Shanghai, Shanghai, China, 200011
Denmark
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Amager, Denmark, 2300
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Frederiksberg, Denmark, 2000
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Herlev, Denmark, 2730
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Horsholm, Denmark, 2970
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Hvidovre, Denmark, 2650
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Kobenhavn Nv, Denmark, 2400
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Silkeborg, Denmark, 8600
France
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Nice, France, 06200
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Paris, France, 75019
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Paris, France, 75679
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Paris, France, 75014
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Saint Etienne, France, 42100
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Saint-Saulve, France, 59880
Germany
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Frankfurt, Germany, 60528
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Frankfurt / Main, Germany, 65929
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Rheinfelden, Germany, 79618
Hungary
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Budapest, Hungary, 1081
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Kecskemet, Hungary, 6000
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Szeged, Hungary, 6720
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Szolnok, Hungary, 5000
India
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Ahmedabad, Gujarat, India, 380015
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Ludhiana, Punjab, India, 141001
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Lucknow, Uttar Prsdesh, India, 226003
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Bangalore, India, 560034
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Mangalore, India, 575001
Israel
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Beer Sheva, Israel, 84101
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Haifa, Israel, 31096
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Holon, Israel, 58100
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Kfar-Saba, Israel, 44281
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Zerifin, Israel, 70300
Mexico
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Tijuana, Baja California, Mexico, 22010
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Mexico City, Distrito Federal, Mexico, 07760
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Mexico City, Distrito Federal, Mexico, 06726
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Guadalajara, Jalisco, Mexico, 45235
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Monterrey, Nuevo Leon, Mexico, 64460
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Cd. Madero, Tamaulipas, Mexico, 89240
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Aguascalientes, Mexico, 20010
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Chihuahua, Mexico, 31020
Norway
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Gjettum, Norway, 1346
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Kongsvinger, Norway, 2212
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Lillehammer, Norway, 2629
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Tonsberg, Norway, 3116
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Tynset, Norway, 2500
Poland
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Gdansk, Poland, 80-803
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Lodz, Poland, 91-002
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Szczecin, Poland, 71-252
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Warszawa, Poland, 03-242
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Warszawa, Poland, 02-005
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Wroclaw, Poland, 50-556
Romania
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Bucharest, Romania, 021659
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Cluj Napoca, Romania, 400132
Russian Federation
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Chelyabinsk, Russian Federation, 454021
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Kazan, Russian Federation, 420029
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Moscow, Russian Federation, 119415
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Moscow, Russian Federation, 115522
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Moscow, Russian Federation, 117292
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Moscow, Russian Federation, 111539
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Saint Petersburg, Russian Federation, 194354
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Saint Petersburg, Russian Federation, 195427
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Saint Petersburg, Russian Federation, 196247
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Saint Petersburg, Russian Federation, 193312
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Saint Petersburg, Russian Federation, 199106
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Samara, Russian Federation, 443095
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St.Petersburg, Russian Federation, 192242
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Yaroslavl, Russian Federation, 150003
Spain
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Badalona-Barcelone, Spain, 08916
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Barcelona, Spain, 08036
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Barcelona, Spain, 08035
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Barcelona, Spain, 08024
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Barcelona, Spain, 08006
Sweden
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Gothenburg, Sweden, 416 85
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Stockholm, Sweden, 182 88
Ukraine
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Cherkassy, Ukraine, 18009
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Chernivtsy, Ukraine, 58013
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Dnipropetrovsk, Ukraine, 49005
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Ivano-Frankivsk, Ukraine, 76008
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Kyiv, Ukraine, 01601
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Kyiv, Ukraine, 04107
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Sevastopol, Ukraine, 99018
United Kingdom
Local Institution
London, Greater London, United Kingdom, SE5 9RS
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Wigan, Lancashire, United Kingdom, WN6 9EP
Local Institution
Epsom, Surrey, United Kingdom, KT18 7EG
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00423319     History of Changes
Other Study ID Numbers: CV185-035
Study First Received: January 17, 2007
Results First Received: April 14, 2014
Last Updated: April 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Prevention of deep vein thrombosis and
pulmonary embolism after total hip replacement surgery

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Thromboembolism
Enoxaparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 20, 2014