Trial · NCT00439777
Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism - The EINSTEIN PE Study
NCT00439777, Phase 3, Completed, Bayer; results first posted 2013-01-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism - The EINSTEIN PE Study. Trials, record NCT00439777. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00439777
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism - The EINSTEIN PE Study
- NCT number
- NCT00439777
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 4,833 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Pulmonary Embolism
- Interventions
- Rivaroxaban (Xarelto, BAY59-7939), Enoxaparin overlapping with and followed by VKA
- First posted
- 2007-02-26
- Last updated
- 2014-02-27
- Other registries' IDs
- eudract:2006-004495-13
- Results first posted
- 2013-01-24
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment | 3-, 6-, or 12-month study treatment period | All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), and/or case summaries. |
| Secondary | Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality Until the Intended End of Study Treatment | 3-, 6-, or 12-month study treatment period | All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for deaths), results/films/images of confirmatory testing, and/or case summaries. |
| Secondary | Percentage of Participants With an Event for Net Clinical Benefit 1 Until the Intended End of Study Treatment | 3-, 6-, or 12-month study treatment period | Net clinical benefit 1: composite of recurrent DVT or non-fatal or fatal PE, and major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. |
| Secondary | Percentage of Participants With Recurrent PE Until the Intended End of Study Treatment | 3-, 6- or 12-month study treatment period | All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. |
| Secondary | Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment | 3-, 6- or 12-month study treatment period | All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries. |
| Secondary | Percentage of Participants With Clinically Relevant Bleeding, Treatment-emergent (Time Window: Until 2 Days After Last Dose) | 3-, 6- or 12-month study treatment period | All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Clinically relevant bleeding included major bleeding (overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of activities of daily life. |
| Secondary | Percentage of Participants With All Deaths | 3-, 6- or 12-month study treatment period | All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either autopsy, results/films/images of confirmatory testing, and/or case summaries. |
| Secondary | Percentage of Participants With Other Vascular Events, On-treatment (Time Window: Until 1 Day After Last Dose) | 3-, 6- or 12-month study treatment period | All pre-defined vascular events (ST segment elevation myocardial infarction, non ST segment elevation myocardial infarction, unstable angina, ischemic stroke, transient ischemic attack, non-central nervous system systemic embolism or vascular death) were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based results/films/images of confirmatory testing, and/or case summaries. |
| Other | Percentage of Participants With the Individual Components of Efficacy Outcomes Until the Intended End of Study Treatment | 3-, 6- or 12-month study treatment period | All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. |
| Other | Percentage of Participants With Symptomatic Recurrent VTE (i.e. the Composite of Recurrent DVT or Fatal or Non-fatal PE) During Observational Period | Up to 30 days after the last intake of study medication | All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), and/or case summaries. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment | 3-, 6-, or 12-month study treatment period | The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality Until the Intended End of Study Treatment | 3-, 6-, or 12-month study treatment period | The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With an Event for Net Clinical Benefit 1 Until the Intended End of Study Treatment | 3-, 6-, or 12-month study treatment period | The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Recurrent PE Until the Intended End of Study Treatment | 3-, 6- or 12-month study treatment period | The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment | 3-, 6- or 12-month study treatment period | The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinically Relevant Bleeding, Treatment-emergent (Time Window: Until 2 Days After Last Dose) | 3-, 6- or 12-month study treatment period | The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of anticoagulant study treatment after randomization (i.e. enoxaparin, warfarin, acenocoumarol, rivaroxaban). Participants were analyzed according to the treatment they actually received. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With All Deaths | 3-, 6- or 12-month study treatment period | The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of anticoagulant study treatment after randomization (i.e. enoxaparin, warfarin, acenocoumarol, rivaroxaban). Participants were analyzed according to the treatment they actually received. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Other Vascular Events, On-treatment (Time Window: Until 1 Day After Last Dose) | 3-, 6- or 12-month study treatment period | The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of anticoagulant study treatment after randomization (i.e. enoxaparin, warfarin, acenocoumarol, rivaroxaban). Participants were analyzed according to the treatment they actually received. | Percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Percentage of Participants With the Individual Components of Efficacy Outcomes Until the Intended End of Study Treatment | 3-, 6- or 12-month study treatment period | The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization. | Percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Percentage of Participants With Symptomatic Recurrent VTE (i.e. the Composite of Recurrent DVT or Fatal or Non-fatal PE) During Observational Period | Up to 30 days after the last intake of study medication | Participants entering the observational period were participants for whom the investigator indicated on the eCRF (electronic case report form) that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome. | Percentage of participants | NUMBER |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group68
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment | Rivaroxaban (Xarelto, BAY59-7939) | 2.1 | Percentage of participants | ||
Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment | Enoxaparin/VKA | 1.8 | Percentage of participants | ||
| Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality Until the Intended End of Study Treatment | Rivaroxaban (Xarelto, BAY59-7939) | 4.0 | Percentage of participants | ||
| Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality Until the Intended End of Study Treatment | Enoxaparin/VKA | 3.4 | Percentage of participants | ||
| Percentage of Participants With an Event for Net Clinical Benefit 1 Until the Intended End of Study Treatment | Rivaroxaban (Xarelto, BAY59-7939) | 3.4 | Percentage of participants | ||
| Percentage of Participants With an Event for Net Clinical Benefit 1 Until the Intended End of Study Treatment | Enoxaparin/VKA | 4.0 | Percentage of participants | ||
| Percentage of Participants With Recurrent PE Until the Intended End of Study Treatment | Rivaroxaban (Xarelto, BAY59-7939) | 1.4 | Percentage of participants | ||
| Percentage of Participants With Recurrent PE Until the Intended End of Study Treatment | Enoxaparin/VKA | 1.2 | Percentage of participants | ||
| Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment | Rivaroxaban (Xarelto, BAY59-7939) | 0.7 | Percentage of participants | ||
| Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment | Enoxaparin/VKA | 0.8 | Percentage of participants |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period | STARTED | Rivaroxaban (Xarelto, BAY59-7939) | 2,420 | |
| Treatment Period | STARTED | Enoxaparin/VKA | 2,413 | |
| Treatment Period | Participants Received Treatment | Rivaroxaban (Xarelto, BAY59-7939) | 2,412 | |
| Treatment Period | Participants Received Treatment | Enoxaparin/VKA | 2,405 | |
| Treatment Period | COMPLETED | Rivaroxaban (Xarelto, BAY59-7939) | 2,001 | |
| Treatment Period | COMPLETED | Enoxaparin/VKA | 1,954 | |
| Treatment Period | NOT COMPLETED | Rivaroxaban (Xarelto, BAY59-7939) | 419 | |
| Treatment Period | NOT COMPLETED | Enoxaparin/VKA | 459 | |
| Observational Period | STARTED | Rivaroxaban (Xarelto, BAY59-7939) | 2,206 | |
| Observational Period | STARTED | Enoxaparin/VKA | 2,197 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events1,230
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 | Constipation | Gastrointestinal disorders | Rivaroxaban (Xarelto, BAY59-7939) | 146 | 2,412 | |
| other | Constipation | Gastrointestinal disorders | Enoxaparin/VKA | 141 | 2,405 | |
| other | Diarrhoea | Gastrointestinal disorders | Rivaroxaban (Xarelto, BAY59-7939) | 128 | 2,412 | |
| other | Diarrhoea | Gastrointestinal disorders | Enoxaparin/VKA | 132 | 2,405 | |
| other | Nausea | Gastrointestinal disorders | Rivaroxaban (Xarelto, BAY59-7939) | 113 | 2,412 | |
| other | Nausea | Gastrointestinal disorders | Enoxaparin/VKA | 131 | 2,405 | |
| other | Chest pain | General disorders | Rivaroxaban (Xarelto, BAY59-7939) | 179 | 2,412 | |
| other | Chest pain | General disorders | Enoxaparin/VKA | 181 | 2,405 | |
| other | Nasopharyngitis | Infections and infestations | Rivaroxaban (Xarelto, BAY59-7939) | 188 | 2,412 | |
| other | Nasopharyngitis | Infections and infestations | Enoxaparin/VKA | 195 | 2,405 |
1 to 10 of 1,230Source ClinicalTrials.gov
See all 1,230 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rivaroxaban (Xarelto, BAY59-7939) | ||
| Total, all-cause mortality | Enoxaparin/VKA | ||
| Total, other adverse events | Rivaroxaban (Xarelto, BAY59-7939) | 1,053 | 2,412 |
| Total, other adverse events | Enoxaparin/VKA | 1,065 | 2,405 |
| Total, serious adverse events | Rivaroxaban (Xarelto, BAY59-7939) | 504 | 2,412 |
| Total, serious adverse events | Enoxaparin/VKA | 495 | 2,405 |
Source ClinicalTrials.gov
Papers12
The papers the trial lists on ClinicalTrials.gov.
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 (Xarelto, BAY59-7939) vs Enoxaparin/VKA: 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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00439777
GET https://conductscience.org/api/trials/v1/NCT00439777/results?page=2