Trial · NCT00657150
Dabigatran Etexilate Compared With Enoxaparin in Prevention of Venous Thromboembolism (VTE) Following Total Hip Arthroplasty
NCT00657150, Phase 3, Completed, Boehringer Ingelheim; results first posted 2010-12-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dabigatran Etexilate Compared With Enoxaparin in Prevention of Venous Thromboembolism (VTE) Following Total Hip Arthroplasty. Trials, record NCT00657150. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00657150
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dabigatran Etexilate Compared With Enoxaparin in Prevention of Venous Thromboembolism (VTE) Following Total Hip Arthroplasty
- NCT number
- NCT00657150
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,055 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Venous Thromboembolism
- Interventions
- Enoxaparin, Dabigatran etexilate
- First posted
- 2008-04-14
- Last updated
- 2014-07-02
- Other registries' IDs
- eudract:2007-002630-11
- Results first posted
- 2010-12-17
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period | 28-35 days | Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine venography), symptomatic DVT (confirmed by venous duplex, ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy). All of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients. |
| Secondary | Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period | 28-35 days | Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee |
| Secondary | Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period | 28-35 days | Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee |
| Secondary | Number of Participants With Total Deep Vein Thrombosis During Treatment Period | 28-35 days | Total Deep Vein Thrombosis as adjudicated by the VTE events committee |
| Secondary | Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period | 28-35 days | Symptomatic Deep Vein Thrombosis, confirmed by venous duplex, ultrasound, venography or autopsy, and as adjudicated by the VTE events committee |
| Secondary | Number of Participants With Pulmonary Embolism During Treatment Period | 28-35 days | Pulmonary embolism confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy, and as adjudicated by the VTE events committee |
| Secondary | Number of Participants Who Died During Treatment Period | 28-35 days | All cause death, as adjudicated by the VTE events committee |
| Secondary | Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period | 3 months | Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine venography), symptomatic DVT (confirmed by venous duplex, ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy). |
| Secondary | Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period | 28-35 days | Major bleeding events were defined as * fatal * clinically overt associated with loss of haemoglobin \>=20g/L in excess of what was expected * clinically overt leading to the transfusion of \>=2 units packed cells or whole blood in excess of what was expected * symptomatic retroperitoneal, intracranial, intraocular or intraspinal * requiring treatment cessation * leading to re-operation Clinically-relevant was defined as * spontaneous skin hematoma \>=25 cm² * wound hematoma \>=100 cm² * spontaneous nose bleed \>5 min * macroscopic hematuria spontaneous or \>24 hours if associated with an intervention * spontaneous rectal bleeding * gingival bleeding \>5 min * any other bleeding event considered clinically relevant by the investigator Any bleeding events were defined as major, clinically-relevant and minor bleeding events. Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above. |
| Secondary | Blood Transfusion | Day 1 | Number of treated and operated patients with required blood transfusion on day of surgery. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period | 28-35 days | Full Analysis Set (randomised, had taken at least 1 dose of oral or subcutaneous trial medication, had undergone surgery, had evaluable negative venogram for both distal and proximal DVT in both legs or positive venography in any 1 segment of 1 or both legs, or confirmed symptomatic DVT, PE or death during the treatment period.) | Participants | NUMBER |
| SECONDARY | Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period | 28-35 days | Full Analysis Set-major (randomised, had taken at least 1 dose of oral or subcutaneous trial medication, had undergone surgery, had evaluable negative venogram for proximal DVT in both legs or a positive venogram for proximal DVT in either leg or confirmed symptomatic proximal DVT, PE or death related to VTE during the treatment period.) | Participants | NUMBER |
| SECONDARY | Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period | 28-35 days | Full Analysis Set - pDVT (all patients who had been randomised, had taken at least 1 dose of oral or subcutaneous trial medication, had undergone surgery (i.e. a date of surgery was reported), evaluable negative venogram for proximal DVT in both legs or positive venogram in either leg or confirmed symptomatic proximal DVT) | Participants | NUMBER |
| SECONDARY | Number of Participants With Total Deep Vein Thrombosis During Treatment Period | 28-35 days | Full Analysis Set-tDVT (randomised, had taken at least 1 dose of oral or subcutaneous trial medication, had undergone surgery, evaluable negative venogram for both distal and proximal DVT in both legs or positive venography in any 1 segment of 1 or both legs, or confirmed symptomatic DVT.) | Participants | NUMBER |
| SECONDARY | Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period | 28-35 days | Full Analysis Set - op (all patients who had been randomised, had taken at least 1 dose of oral or subcutaneous trial medication or had undergone surgery (i.e. a date of surgery was reported) | Participants | NUMBER |
| SECONDARY | Number of Participants With Pulmonary Embolism During Treatment Period | 28-35 days | Full Analysis Set - op (all patients who had been randomised, had taken at least 1 dose of oral or subcutaneous trial medication or had undergone surgery (i.e. a date of surgery was reported) | Participants | NUMBER |
| SECONDARY | Number of Participants Who Died During Treatment Period | 28-35 days | Full Analysis Set - op (all patients who had been randomised, had taken at least 1 dose of oral or subcutaneous trial medication or had undergone surgery (i.e. a date of surgery was reported) | Participants | NUMBER |
| SECONDARY | Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period | 3 months | Patients with any data available during follow-up | Participants | NUMBER |
| SECONDARY | Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period | 28-35 days | All patients who had been randomised, had taken at least 1 dose of oral or subcutaneous trial medication. | Participants | NUMBER |
| SECONDARY | Blood Transfusion | Day 1 | Treated and operated patients | participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period | Dabigatran 220mg | 61 | Participants | ||
| Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period | Enoxaparin | 69 | Participants | ||
| Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period | Dabigatran 220mg | 18 | Participants | ||
| Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period | Enoxaparin | 33 | Participants | ||
| Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period | Dabigatran 220mg | 17 | Participants | ||
| Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period | Enoxaparin | 31 | Participants | ||
| Number of Participants With Total Deep Vein Thrombosis During Treatment Period | Dabigatran 220mg | 60 | Participants | ||
| Number of Participants With Total Deep Vein Thrombosis During Treatment Period | Enoxaparin | 67 | Participants | ||
| Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period | Dabigatran 220mg | 0 | Participants | ||
| Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period | Enoxaparin | 4 | Participants |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dabigatran 220mg | 1,010 | |
| Overall Study | STARTED | Enoxaparin | 1,003 | |
| Overall Study | COMPLETED | Dabigatran 220mg | 895 | |
| Overall Study | COMPLETED | Enoxaparin | 910 | |
| Overall Study | NOT COMPLETED | Dabigatran 220mg | 115 | |
| Overall Study | NOT COMPLETED | Enoxaparin | 93 | |
| Treatment | STARTED | Dabigatran 220mg | 1,010 | |
| Treatment | STARTED | Enoxaparin | 1,003 | |
| Treatment | COMPLETED | Dabigatran 220mg | 903 | |
| Treatment | COMPLETED | Enoxaparin | 906 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events212
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 | Dabigatran 220mg | 100 | 1,010 | |
| other | Constipation | Gastrointestinal disorders | Enoxaparin | 102 | 1,003 | |
| other | Nausea | Gastrointestinal disorders | Dabigatran 220mg | 162 | 1,010 | |
| other | Nausea | Gastrointestinal disorders | Enoxaparin | 166 | 1,003 | |
| other | Vomiting | Gastrointestinal disorders | Dabigatran 220mg | 110 | 1,010 | |
| other | Vomiting | Gastrointestinal disorders | Enoxaparin | 94 | 1,003 | |
| other | Pyrexia | General disorders | Dabigatran 220mg | 62 | 1,010 | |
| other | Pyrexia | General disorders | Enoxaparin | 80 | 1,003 | |
| other | Haemoglobin decreased | Investigations | Dabigatran 220mg | 56 | 1,010 | |
| other | Haemoglobin decreased | Investigations | Enoxaparin | 62 | 1,003 |
1 to 10 of 212Source ClinicalTrials.gov
See all 212 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dabigatran 220mg | ||
| Total, all-cause mortality | Enoxaparin | ||
| Total, other adverse events | Dabigatran 220mg | 389 | 1,010 |
| Total, other adverse events | Enoxaparin | 389 | 1,003 |
| Total, serious adverse events | Dabigatran 220mg | 57 | 1,010 |
| Total, serious adverse events | Enoxaparin | 59 | 1,003 |
Source ClinicalTrials.gov
Papers2
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 comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dabigatran 220mg vs Enoxaparin: Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period | Trial comparisons |
| Dabigatran 220mg vs Enoxaparin: Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period | Trial comparisons |
| Dabigatran 220mg vs Enoxaparin: Number of Participants Who Died During Treatment Period | Trial comparisons |
| Dabigatran 220mg vs Enoxaparin: Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period | Trial comparisons |
| Dabigatran 220mg vs Enoxaparin: Number of Participants With Total Deep Vein Thrombosis During Treatment Period | Trial comparisons |
| Dabigatran 220mg vs Enoxaparin: Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period | Trial comparisons |
| Dabigatran 220mg vs Enoxaparin: Number of Participants With Pulmonary Embolism During Treatment Period | Trial comparisons |
| Dabigatran 220mg vs Enoxaparin: serious adverse events | 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/NCT00657150
GET https://conductscience.org/api/trials/v1/NCT00657150/results?page=2