Trial · NCT00558259
Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long Term Prevention of Recurrent Symptomatic VTE
NCT00558259, Phase 3, Completed, Boehringer Ingelheim; results first posted 2012-03-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long Term Prevention of Recurrent Symptomatic VTE. Trials, record NCT00558259. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00558259
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long Term Prevention of Recurrent Symptomatic VTE
- NCT number
- NCT00558259
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,353 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Venous Thromboembolism
- Interventions
- dabigatran etexilate 150 mg twice daily (BID), matching placebo twice daily (BID)
- First posted
- 2007-11-14
- Last updated
- 2014-06-27
- Other registries' IDs
- eudract:2007-002586-12
- Results first posted
- 2012-03-02
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period | 6 months | Symptomatic recurrent VTE is the composite of recurrent deep vein thrombosis (DVT) , fatal or non-fatal pulmonary embolism (PE). Whilst the endpoint is time to event, the measured values present the number of participant with event and the hazard ratio presents the time to event. |
| Secondary | Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Excluding Unexplained Death During the Intended Treatment Period | 6 months | Symptomatic recurrent VTE is the composite of recurrent deep vein thrombosis (DVT) , fatal or non-fatal pulmonary embolism (PE). Whilst the endpoint is time to event, the measured values present the number of participant with event and the hazard ratio presents the time to event. |
| Secondary | Centrally Confirmed Symptomatic Recurrent Deep Venous Thrombotic (DVT) Events During the Intended Treatment Period | 6 months | Number of the participants with centrally confirmed symptomatic recurrent deep venous thrombotic (DVT) events during the intended treatment period were described. |
| Secondary | Centrally Confirmed Symptomatic Pulmonary Embolism (PE) Events During the Intended Treatment Period | 6 months | Number of participants with centrally confirmed symptomatic pulmonary embolism (PE) events during the intended treatment period were described. |
| Secondary | Centrally Confirmed Unexplained Deaths During the Intended Treatment Period | 6 months | Number of participants with centrally confirmed unexplained deaths during the intended treatment period were described. |
| Secondary | Centrally Confirmed Bleeding Event During the Treatment Period | 6 months | Major bleeding events (MBE) had to fulfil at least 1 of the following criteria: * Fatal bleeding * Associated with a fall in haemoglobin of ≥2 g/dL * Led to the transfusion of ≥2 units packed cells or whole blood * Occurred in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal Other clinically relevant bleeding was defined as overt bleeding not meeting the criteria for an MBE but associated with medical intervention, unscheduled contact with a physician, (temporary) cessation of study treatment, or associated with discomfort such as pain, or impairment of activities of daily life. Examples of these bleedings were: * Bleeding that compromised haemodynamics * Bleeding that led to hospitalisation Trivial bleeding events were defined as all other bleeding events that did not fulfil the criteria of MBEs or CRBEs. All bleeding events include MBEs, CRBEs, and trivial bleeding events. |
| Secondary | Centrally Confirmed Cardiovascular Events During the Treatment Period | 6 months | Cardiovascular events that occurred during the treatment period + 3 days were summarised by treatment groups. |
| Secondary | Laboratory Measures, Especially Liver Function Tests (LFTs) | 6 months | Number of participants with possible clinically significant abnormalities during the treatment period. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period | 6 months | Full analysis set (FAS) and analysed as randomised. FAS is defined as randomised and treated. | Participants | NUMBER |
| SECONDARY | Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Excluding Unexplained Death During the Intended Treatment Period | 6 months | FAS and analysed as randomised. | Participants | NUMBER |
| SECONDARY | Centrally Confirmed Symptomatic Recurrent Deep Venous Thrombotic (DVT) Events During the Intended Treatment Period | 6 months | FAS and analysed as randomised. | Participants | NUMBER |
| SECONDARY | Centrally Confirmed Symptomatic Pulmonary Embolism (PE) Events During the Intended Treatment Period | 6 months | FAS and analysed as randomised. | Participants | NUMBER |
| SECONDARY | Centrally Confirmed Unexplained Deaths During the Intended Treatment Period | 6 months | FAS and analysed as randomised. | participants | NUMBER |
| SECONDARY | Centrally Confirmed Bleeding Event During the Treatment Period | 6 months | FAS and analysed as treated. There were 3 participants who were randomised to placebo but treated with dabigatran only. | participants | NUMBER |
| SECONDARY | Centrally Confirmed Cardiovascular Events During the Treatment Period | 6 months | FAS and analysed as treated. There were 3 participants who were randomised to placebo but treated with dabigatran only. | participants | NUMBER |
| SECONDARY | Laboratory Measures, Especially Liver Function Tests (LFTs) | 6 months | FAS - As Treated Assignment | participants | NUMBER |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period | Dabigatran | 3 | 0.0 | Participants | |
| Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period | Placebo | 37 | 0.0 | Participants | |
| Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Excluding Unexplained Death During the Intended Treatment Period | Dabigatran | 3 | Participants | ||
| Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Excluding Unexplained Death During the Intended Treatment Period | Placebo | 35 | Participants | ||
| Centrally Confirmed Symptomatic Recurrent Deep Venous Thrombotic (DVT) Events During the Intended Treatment Period | Dabigatran | 2 | Participants | ||
| Centrally Confirmed Symptomatic Recurrent Deep Venous Thrombotic (DVT) Events During the Intended Treatment Period | Placebo | 23 | Participants | ||
| Centrally Confirmed Symptomatic Pulmonary Embolism (PE) Events During the Intended Treatment Period | Dabigatran | 1 | Participants | ||
| Centrally Confirmed Symptomatic Pulmonary Embolism (PE) Events During the Intended Treatment Period | Placebo | 14 | Participants | ||
| Centrally Confirmed Unexplained Deaths During the Intended Treatment Period | Dabigatran | 0 | participants | ||
| Centrally Confirmed Unexplained Deaths During the Intended Treatment Period | Placebo | 2 | participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dabigatran | 681 | |
| Overall Study | STARTED | Placebo | 662 | |
| Overall Study | COMPLETED | Dabigatran | 610 | |
| Overall Study | COMPLETED | Placebo | 563 | |
| Overall Study | NOT COMPLETED | Dabigatran | 71 | |
| Overall Study | NOT COMPLETED | Placebo | 99 |
Source ClinicalTrials.gov
Adverse events178
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 |
|---|---|---|---|---|---|---|
| serious | Anaemia | Blood and lymphatic system disorders | Dabigatran | 1 | 684 | |
| serious | Anaemia | Blood and lymphatic system disorders | Placebo | 0 | 659 | |
| serious | Splenomegaly | Blood and lymphatic system disorders | Dabigatran | 0 | 684 | |
| serious | Splenomegaly | Blood and lymphatic system disorders | Placebo | 1 | 659 | |
| serious | Acute myocardial infarction | Cardiac disorders | Dabigatran | 1 | 684 | |
| serious | Acute myocardial infarction | Cardiac disorders | Placebo | 1 | 659 | |
| serious | Angina pectoris | Cardiac disorders | Dabigatran | 0 | 684 | |
| serious | Angina pectoris | Cardiac disorders | Placebo | 1 | 659 | |
| serious | Atrial fibrillation | Cardiac disorders | Dabigatran | 0 | 684 | |
| serious | Atrial fibrillation | Cardiac disorders | Placebo | 2 | 659 |
1 to 10 of 178Source ClinicalTrials.gov
See all 178 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dabigatran | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Dabigatran | 0 | 684 |
| Total, other adverse events | Placebo | 0 | 659 |
| Total, serious adverse events | Dabigatran | 47 | 684 |
| Total, serious adverse events | Placebo | 60 | 659 |
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 comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dabigatran vs Placebo: Centrally Confirmed Symptomatic Recurrent Deep Venous Thrombotic (DVT) Events During the Intended Treatment Period | Trial comparisons |
| Dabigatran vs Placebo: Centrally Confirmed Unexplained Deaths During the Intended Treatment Period | Trial comparisons |
| Dabigatran vs Placebo: Centrally Confirmed Cardiovascular Events During the Treatment Period | Trial comparisons |
| Dabigatran vs Placebo: Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period | Trial comparisons |
| Dabigatran vs Placebo: Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Excluding Unexplained Death During the Intended Treatment Period | Trial comparisons |
| Dabigatran vs Placebo: Centrally Confirmed Symptomatic Pulmonary Embolism (PE) Events During the Intended Treatment Period | Trial comparisons |
| Dabigatran vs Placebo: 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/NCT00558259
GET https://conductscience.org/api/trials/v1/NCT00558259/results?page=2