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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00423319
Registration number
NCT00423319
Ethics application status
Date submitted
17/01/2007
Date registered
18/01/2007
Date last updated
14/05/2014
Titles & IDs
Public title
Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Hip Replacement Surgery (ADVANCE-3)
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Scientific 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)
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Secondary ID [1]
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CV185-035
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Deep Vein Thrombosis
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Pulmonary Embolism
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Blood
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Clotting disorders
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Respiratory
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Other respiratory disorders / diseases
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Enoxaparin
Treatment: Drugs - Apixaban
Treatment: Drugs - Enoxaparin-matching placebo
Treatment: Drugs - Apixaban-matching placebo
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)
Experimental: Enoxaparin, 40 mg QD plus placebo - Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
Treatment: Drugs: Enoxaparin
Subcutaneous, 40 mg, once daily, 5 weeks
Treatment: Drugs: Apixaban
Oral tablets, 2.5 mg, twice daily, 5weeks
Treatment: Drugs: Enoxaparin-matching placebo
Administered as injection
Treatment: Drugs: Apixaban-matching placebo
Administered as oral tablets
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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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.
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Timepoint [1]
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Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose
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Secondary outcome [1]
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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
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Assessment method [1]
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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.
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Timepoint [1]
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Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose
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Secondary outcome [2]
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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
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Assessment method [2]
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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.
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Timepoint [2]
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Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose
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Secondary outcome [3]
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Rate of Major Bleeding, Clinically Relevant Nonmajor Bleeding (CRNM), Major or CRNM, and Any Bleeding During the Treatment Period
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Assessment method [3]
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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
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Timepoint [3]
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First dose of study drug (presurgery) through 2 days after the last dose of study drug
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Secondary outcome [4]
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Number of Participants With Serious Adverse Events (SAEs), Bleeding Adverse Events (AEs), and Death as Outcome
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Assessment method [4]
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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.
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Timepoint [4]
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First dose of study drug (presurgery) through 30 days after the last dose of study drug
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Secondary outcome [5]
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Number of Participants With a Bleeding-related Adverse Event During the Treatment Period
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Assessment method [5]
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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.
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Timepoint [5]
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First dose of study drug (presurgery) through 2 days after the last dose of study drug
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Secondary outcome [6]
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Number of Participants With a Bleeding-related Adverse Events During the Treatment Period (Continued)
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Assessment method [6]
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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.
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Timepoint [6]
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First dose of study drug (presurgery) through 2 days after the last dose of study drug
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Secondary outcome [7]
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Number of Participants With a Bleeding-related Adverse Event During the Treatment Period (Continued)
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Assessment method [7]
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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.
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Timepoint [7]
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First dose of study drug (presurgery) through 2 days after the last dose of study drug
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Secondary outcome [8]
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Number of Participants With Neurologic Adverse Events With Onset During the Treatment Period
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Assessment method [8]
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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.
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Timepoint [8]
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First dose of study drug (presurgery) through 2 days after the last dose of study drug
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Secondary outcome [9]
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Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period
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Assessment method [9]
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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;
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Timepoint [9]
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First dose of study drug (presurgery) through 2 days after the last dose of study drug
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Secondary outcome [10]
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Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period (Continued)
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Assessment method [10]
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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.
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Timepoint [10]
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First dose of study drug (presurgery) through 2 days after the last dose of study drug
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Secondary outcome [11]
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Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period (Continued)
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Assessment method [11]
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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.
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Timepoint [11]
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First dose of study drug (presurgery) through 2 days after the last dose of study drug
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Secondary outcome [12]
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Number of Participants With Adverse Events Related to Elevations in Liver Function Test Results With Onset During the Treatment Period
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Assessment method [12]
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Treatment guidelines were provided for jaundice and elevated results of liver function tests.
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Timepoint [12]
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First dose of study drug (presurgery) through 30 days after the last dose of study drug
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Secondary outcome [13]
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Rates of Adjudicated Myocardial Infarction (MI)/Stroke, MI, Stroke, and Thrombocytopenia During the Intended Treatment Period
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Assessment method [13]
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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.
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Timepoint [13]
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Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose
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Eligibility
Key inclusion 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2009
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Sample size
Target
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Accrual to date
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Final
5407
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Local Institution - Camperdown
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Recruitment hospital [2]
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Local Institution - Kogarah
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Recruitment hospital [3]
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Local Institution - Lismore
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Recruitment hospital [4]
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Local Institution - Southport
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Recruitment hospital [5]
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Local Institution - Bedford Park
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Recruitment hospital [6]
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Local Institution - Box Hill
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Recruitment hospital [7]
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Local Institution - Malvern
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Recruitment hospital [8]
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Local Institution - Windsor
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Recruitment hospital [9]
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Local Institution - Perth
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2217 - Kogarah
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Recruitment postcode(s) [3]
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2480 - Lismore
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Recruitment postcode(s) [4]
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4215 - Southport
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Recruitment postcode(s) [5]
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5042 - Bedford Park
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Recruitment postcode(s) [6]
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3128 - Box Hill
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Recruitment postcode(s) [7]
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3144 - Malvern
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Recruitment postcode(s) [8]
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3181 - Windsor
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Recruitment postcode(s) [9]
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6000 - Perth
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Recruitment outside Australia
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United States of America
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State/province [1]
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Alabama
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United States of America
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Arkansas
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California
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Colorado
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Florida
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Georgia
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Idaho
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Pennsylvania
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Texas
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Argentina
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Buenos Aires
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Belgium
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Antwerp
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Belgium
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Brasschaat
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Belgium
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Genk
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Belgium
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Hasselt
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Belgium
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Leuven
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Canada
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Alberta
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Canada
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Ontario
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Canada
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Quebec
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China
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Beijing
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China
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Guangdong
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China
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Shandong
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China
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Shanghai
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Amager
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Frederiksberg
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Herlev
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Horsholm
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Hvidovre
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Silkeborg
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France
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Nice
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France
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Paris
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France
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Saint Etienne
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France
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Saint-Saulve
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Germany
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Frankfurt / Main
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Germany
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Frankfurt
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Germany
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Rheinfelden
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Hungary
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Budapest
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Hungary
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Kecskemet
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Hungary
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Szeged
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Hungary
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Szolnok
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India
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Funding & Sponsors
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Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Summary
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
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00423319
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Contacts
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Bristol-Myers Squibb
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Bristol-Myers Squibb
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00423319
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