Trial · NCT00362232
Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thromboembolism (DVT) and Pulmonary Embolism (PE). A Study of BAY59-7939 in the Prevention of Venous Thrombo Embolism (VTE) in Subjects Undergoing Elective Total Knee Replacement.
NCT00362232, Phase 3, Completed, Bayer; results first posted 2012-06-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thromboembolism (DVT) and Pulmonary Embolism (PE). A Study of BAY59-7939 in the Prevention of Venous Thrombo Embolism (VTE) in Subjects Undergoing Elective Total Knee Replacement. Trials, record NCT00362232. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00362232
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thromboembolism (DVT) and Pulmonary Embolism (PE). A Study of BAY59-7939 in the Prevention of Venous Thrombo Embolism (VTE) in Subjects Undergoing Elective Total Knee Replacement.
- NCT number
- NCT00362232
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,148 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Venous Thromboembolism
- Interventions
- Rivaroxaban (Xarelto, BAY59-7939), Enoxaparin, Placebo: tablet of Rivaroxaban, Placebo: syringes of Enoxaparin
- First posted
- 2006-08-09
- Last updated
- 2014-11-04
- Other registries' IDs
- eudract:2006-002402-60
- Results first posted
- 2012-06-13
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Composite Endpoint of Total Venous Thrombo Embolism (VTE) i.e.: Any Deep Vein Thromboembolism (DVT) (Proximal and/or Distal), Non Fatal Pulmonary Embolism (PE), Death of All Causes Per Protocol Population | Up to 16 days after surgery | Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography |
| Primary | Composite Endpoint of Total VTE i.e.: Any DVT (Proximal and/or Distal), Non Fatal PE, Death of All Causes Per Modified Intent to Treat Population. | Up to 16 days after surgery | Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography |
| Secondary | Incidence of the Composite Endpoint Comprising Proximal DVT, Non-fatal PE and VTE- Related Death (Major VTE) Per Protocol Population of Major VTE | Up to 16 days after surgery | Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography |
| Secondary | Incidence of the Composite Endpoint Comprising Proximal DVT, Non-fatal PE and VTE- Related Death (Major VTE) Per Modified Intent to Treat Population of Major VTE. | Up to 16 days after surgery | Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography |
| Secondary | Incidence of Symptomatic VTE (DVT, PE) Per Protocol Population. | Up to 16 days after surgery | Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography |
| Secondary | Incidence of Symptomatic VTE (DVT, PE) Per Modified Intent to Treat Population. | Up to 16 days after surgery | Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography |
| Secondary | Incidence of DVT (Proximal, Distal) Per Protocol Population. | Up to 16 days after surgery | Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography |
| Secondary | Incidence of DVT (Proximal, Distal) Per Modified Intent to Treat Population. | Up to 16 days after surgery | Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography |
| Secondary | Incidence of Symptomatic VTE During Follow-up Per Protocol Population. | Up to 47 days after surgery | Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography |
| Secondary | Incidence of Symptomatic VTE During Follow-up Per Modified Intent to Treat Population. | Up to 47 days after surgery | Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Composite Endpoint of Total Venous Thrombo Embolism (VTE) i.e.: Any Deep Vein Thromboembolism (DVT) (Proximal and/or Distal), Non Fatal Pulmonary Embolism (PE), Death of All Causes Per Protocol Population | Up to 16 days after surgery | The primary efficacy analysis was based on the per protocol (PP) population and included subjects who were valid for the modified intent to treat (MITT) population, had an adequate assessment of thromboembolism that, in case of a positive finding, was done not later than 36 hours after stop of study drug, and had no major protocol deviations. | Percentage of participants | NUMBER |
| PRIMARY | Composite Endpoint of Total VTE i.e.: Any DVT (Proximal and/or Distal), Non Fatal PE, Death of All Causes Per Modified Intent to Treat Population. | Up to 16 days after surgery | A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism | Percentage of participants | NUMBER |
| SECONDARY | Incidence of the Composite Endpoint Comprising Proximal DVT, Non-fatal PE and VTE- Related Death (Major VTE) Per Protocol Population of Major VTE | Up to 16 days after surgery | The PP population included subjects who were valid for the modified intent to treat (MITT) population, had an adequate assessment of thromboembolism that, in case of a positive finding, was done not later than 36 hours after stop of study drug, and had no major protocol deviations. | percentage of participants | NUMBER |
| SECONDARY | Incidence of the Composite Endpoint Comprising Proximal DVT, Non-fatal PE and VTE- Related Death (Major VTE) Per Modified Intent to Treat Population of Major VTE. | Up to 16 days after surgery | A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism | percentage of participants | NUMBER |
| SECONDARY | Incidence of Symptomatic VTE (DVT, PE) Per Protocol Population. | Up to 16 days after surgery | The PP population included subjects who were valid for the modified intent to treat (MITT) population, had an adequate assessment of thromboembolism that, in case of a positive finding, was done not later than 36 hours after stop of study drug, and had no major protocol deviations | percentage of participants | NUMBER |
| SECONDARY | Incidence of Symptomatic VTE (DVT, PE) Per Modified Intent to Treat Population. | Up to 16 days after surgery | A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism | percentage of participants | NUMBER |
| SECONDARY | Incidence of DVT (Proximal, Distal) Per Protocol Population. | Up to 16 days after surgery | The PP population included subjects who were valid for the modified intent to treat (MITT) population, had an adequate assessment of thromboembolism that, in case of a positive finding, was done not later than 36 hours after stop of study drug, and had no major protocol deviations | percentage of participants | NUMBER |
| SECONDARY | Incidence of DVT (Proximal, Distal) Per Modified Intent to Treat Population. | Up to 16 days after surgery | A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism | percentage of participants | NUMBER |
| SECONDARY | Incidence of Symptomatic VTE During Follow-up Per Protocol Population. | Up to 47 days after surgery | The PP population included subjects who were valid for the modified intent to treat (MITT) population, had an adequate assessment of thromboembolism that, in case of a positive finding, was done not later than 36 hours after stop of study drug, and had no major protocol deviations | percentage of participants | NUMBER |
| SECONDARY | Incidence of Symptomatic VTE During Follow-up Per Modified Intent to Treat Population. | Up to 47 days after surgery | A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism | percentage of participants | NUMBER |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Composite Endpoint of Total Venous Thrombo Embolism (VTE) i.e.: Any Deep Vein Thromboembolism (DVT) (Proximal and/or Distal), Non Fatal Pulmonary Embolism (PE), Death of All Causes Per Protocol Population | Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939) | 6.71 | Percentage of participants | ||
Composite Endpoint of Total Venous Thrombo Embolism (VTE) i.e.: Any Deep Vein Thromboembolism (DVT) (Proximal and/or Distal), Non Fatal Pulmonary Embolism (PE), Death of All Causes Per Protocol Population | Enoxaparin 30 mg Twice a Day (Bid) | 9.34 | Percentage of participants | ||
| Composite Endpoint of Total VTE i.e.: Any DVT (Proximal and/or Distal), Non Fatal PE, Death of All Causes Per Modified Intent to Treat Population. | Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939) | 6.94 | Percentage of participants | ||
| Composite Endpoint of Total VTE i.e.: Any DVT (Proximal and/or Distal), Non Fatal PE, Death of All Causes Per Modified Intent to Treat Population. | Enoxaparin 30 mg Twice a Day (Bid) | 10.11 | Percentage of participants | ||
| Incidence of the Composite Endpoint Comprising Proximal DVT, Non-fatal PE and VTE- Related Death (Major VTE) Per Protocol Population of Major VTE | Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939) | 1.09 | percentage of participants | ||
| Incidence of the Composite Endpoint Comprising Proximal DVT, Non-fatal PE and VTE- Related Death (Major VTE) Per Protocol Population of Major VTE | Enoxaparin 30 mg Twice a Day (Bid) | 1.47 | percentage of participants | ||
| Incidence of the Composite Endpoint Comprising Proximal DVT, Non-fatal PE and VTE- Related Death (Major VTE) Per Modified Intent to Treat Population of Major VTE. | Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939) | 1.16 | percentage of participants | ||
| Incidence of the Composite Endpoint Comprising Proximal DVT, Non-fatal PE and VTE- Related Death (Major VTE) Per Modified Intent to Treat Population of Major VTE. | Enoxaparin 30 mg Twice a Day (Bid) | 1.98 | percentage of participants | ||
| Incidence of Symptomatic VTE (DVT, PE) Per Protocol Population. | Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939) | 1.04 | percentage of participants | ||
| Incidence of Symptomatic VTE (DVT, PE) Per Protocol Population. | Enoxaparin 30 mg Twice a Day (Bid) | 1.48 | percentage of participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment (12 +/- 2 Days) | STARTED | Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939) | 1,584 | |
| Treatment (12 +/- 2 Days) | STARTED | Enoxaparin 30 mg Twice a Day (Bid) | 1,564 | |
| Treatment (12 +/- 2 Days) | Received Treatment | Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939) | 1,526 | |
| Treatment (12 +/- 2 Days) | Received Treatment | Enoxaparin 30 mg Twice a Day (Bid) | 1,508 | |
| Treatment (12 +/- 2 Days) | COMPLETED | Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939) | 1,425 | |
| Treatment (12 +/- 2 Days) | COMPLETED | Enoxaparin 30 mg Twice a Day (Bid) | 1,413 | |
| Treatment (12 +/- 2 Days) | NOT COMPLETED | Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939) | 159 | |
| Treatment (12 +/- 2 Days) | NOT COMPLETED | Enoxaparin 30 mg Twice a Day (Bid) | 151 | |
| Follow-up (30 (+ 5) Days) | STARTED | Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939) | 1,471 | |
| Follow-up (30 (+ 5) Days) | STARTED | Enoxaparin 30 mg Twice a Day (Bid) | 1,455 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events464
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939) | 57 | 1,526 | |
| other | Anaemia | Blood and lymphatic system disorders | Enoxaparin 30 mg Twice a Day (Bid) | 51 | 1,508 | |
| other | Thrombocythaemia | Blood and lymphatic system disorders | Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939) | 33 | 1,526 | |
| other | Thrombocythaemia | Blood and lymphatic system disorders | Enoxaparin 30 mg Twice a Day (Bid) | 35 | 1,508 | |
| other | Bradycardia | Cardiac disorders | Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939) | 15 | 1,526 | |
| other | Bradycardia | Cardiac disorders | Enoxaparin 30 mg Twice a Day (Bid) | 16 | 1,508 | |
| other | Tachycardia | Cardiac disorders | Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939) | 96 | 1,526 | |
| other | Tachycardia | Cardiac disorders | Enoxaparin 30 mg Twice a Day (Bid) | 95 | 1,508 | |
| other | Abdominal pain | Gastrointestinal disorders | Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939) | 21 | 1,526 | |
| other | Abdominal pain | Gastrointestinal disorders | Enoxaparin 30 mg Twice a Day (Bid) | 13 | 1,508 |
1 to 10 of 464Source ClinicalTrials.gov
See all 464 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939) | ||
| Total, all-cause mortality | Enoxaparin 30 mg Twice a Day (Bid) | ||
| Total, other adverse events | Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939) | 1,167 | 1,526 |
| Total, other adverse events | Enoxaparin 30 mg Twice a Day (Bid) | 1,152 | 1,508 |
| Total, serious adverse events | Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939) | 106 | 1,526 |
| Total, serious adverse events | Enoxaparin 30 mg Twice a Day (Bid) | 131 | 1,508 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19411100 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939) vs Enoxaparin 30 mg Twice a Day (Bid): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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Read this trial from software.
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