Trial · NCT00680186
Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp Venous Thromboembolism (VTE)
NCT00680186, Phase 3, Completed, Boehringer Ingelheim; results first posted 2012-06-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp Venous Thromboembolism (VTE). Trials, record NCT00680186. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00680186
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp Venous Thromboembolism (VTE)
- NCT number
- NCT00680186
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,589 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Thromboembolism
- Interventions
- Warfarin, Dabigatran etexilate
- First posted
- 2008-05-20
- Last updated
- 2014-05-19
- Other registries' IDs
- eudract:2007-002631-86
- Results first posted
- 2012-06-14
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE | For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180) | All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee. |
| Secondary | Number of Participants With Recurrent Symptomatic VTE and All Deaths | For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224. | VTE or any death which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee. |
| Secondary | Number of Participants With Recurrent Symptomatic DVT | For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224. | Symptomatic DVT which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee. |
| Secondary | Number of Participants With Recurrent Symptomatic Non-fatal PE | For statistical analysis 1: from randomisation to 6 months (up to day 180). For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224. | Symptomatic non-fatal PE which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee. |
| Secondary | Number of Participants Who Died Due to VTE | From randomisation to 6 months (up to day 180) and to end of ptp (planned to be up to day 224) | VTE - related deaths which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee. Hazard ratios and 95% CI were not calculated because of insufficient number of events. |
| Secondary | Number of Participants Who Died (Any Cause) | For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224. | Any deaths which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee. |
| Secondary | Number of Participants With Recurrent Symptomatic Fatal and Non-fatal PE | For statistical analysis 1: from randomisation to 6 months (up to day 180). For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224. | Symptomatic fatal and non-fatal PE which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee. |
| Secondary | Number of Participants With MBE, MBE and/or CRBE, and Any Bleeding Events | From first intake of study drug to last intake of study drug + 6 days washout | Major bleeding events (MBE) are defined as * Fatal bleeding * Symptomatic bleeding in a critical area or organ * Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells Clinically-relevant bleeding events (CRBE) are 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 * leading to hospitalisation and / or requiring surgical treatment * leading to a transfusion of \<2 units of whole blood or red cells * any other bleeding event considered clinically relevant by the investigator Any bleeding events were defined as major, clinically-relevant and nuisance bleeding events. Nuisance bleeding events were defined as all other bleeding events that did not fulfil the criteria from above. |
| Secondary | Number of Participants With Acute Coronary Syndrome (ACS) | From first intake of study drug to last contact date | Any ACS occurring during the conduct of the study (centrally adjudicated as definite). Patients having a centrally adjudicated definite ACS during intake of study drug and after stopping study drug, according to treatment group. ACS assessments pre-specified in the protocol without adjudication. Prior to database lock, the steering committee asked to have ACS events adjudicated by an independent committee. After database lock, the committee was provided with source documentation that was blinded to the patient's treatment assignment. ACS results presented are based on adjudication findings. |
| Secondary | Laboratory Analyses | From first intake of study drug to last intake of study drug + 6 days washout | Frequency of patients with possible clinically significant abnormalities. |
Source ClinicalTrials.gov
Outcomes10
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 Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE | For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180) | Full analysis set (FAS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as randomised, i.e. regardless of the actual medication taken. | participants | NUMBER |
| SECONDARY | Number of Participants With Recurrent Symptomatic VTE and All Deaths | For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224. | FAS | participants | NUMBER |
| SECONDARY | Number of Participants With Recurrent Symptomatic DVT | For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224. | FAS | participants | NUMBER |
| SECONDARY | Number of Participants With Recurrent Symptomatic Non-fatal PE | For statistical analysis 1: from randomisation to 6 months (up to day 180). For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224. | FAS | participants | NUMBER |
| SECONDARY | Number of Participants Who Died Due to VTE | From randomisation to 6 months (up to day 180) and to end of ptp (planned to be up to day 224) | FAS | participants | NUMBER |
| SECONDARY | Number of Participants Who Died (Any Cause) | For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224. | FAS | participants | NUMBER |
| SECONDARY | Number of Participants With Recurrent Symptomatic Fatal and Non-fatal PE | For statistical analysis 1: from randomisation to 6 months (up to day 180). For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224. | FAS | participants | NUMBER |
| SECONDARY | Number of Participants With MBE, MBE and/or CRBE, and Any Bleeding Events | From first intake of study drug to last intake of study drug + 6 days washout | Treated set (TS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as treated. | participants | NUMBER |
| SECONDARY | Number of Participants With Acute Coronary Syndrome (ACS) | From first intake of study drug to last contact date | TS | participants | NUMBER |
| SECONDARY | Laboratory Analyses | From first intake of study drug to last intake of study drug + 6 days washout | TS | participants | NUMBER |
Source ClinicalTrials.gov
Results by group50
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 Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE | Dabigatran 150 mg | Participants with event (up to day 180) | 30 | participants | |
| Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE | Warfarin | Participants with event (up to day 180) | 28 | participants | |
| Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE | Dabigatran 150 mg | Participants with event (up to end of ptp) | 34 | participants | |
| Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE | Warfarin | Participants with event (up to end of ptp) | 30 | participants | |
| Number of Participants With Recurrent Symptomatic VTE and All Deaths | Dabigatran 150 mg | Participants with event (up to day 180) | 51 | participants | |
| Number of Participants With Recurrent Symptomatic VTE and All Deaths | Warfarin | Participants with event (up to day 180) | 48 | participants | |
| Number of Participants With Recurrent Symptomatic VTE and All Deaths | Dabigatran 150 mg | Participants with event (up to end of ptp) | 57 | participants | |
| Number of Participants With Recurrent Symptomatic VTE and All Deaths | Warfarin | Participants with event (up to end of ptp) | 51 | participants | |
| Number of Participants With Recurrent Symptomatic DVT | Dabigatran 150 mg | Participants with event (up to day 180) | 25 | participants | |
| Number of Participants With Recurrent Symptomatic DVT | Warfarin | Participants with event (up to day 180) | 17 | participants |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 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 150 mg | 1,280 | |
| Overall Study | STARTED | Warfarin | 1,288 | |
| Overall Study | COMPLETED | Dabigatran 150 mg | 1,155 | |
| Overall Study | COMPLETED | Warfarin | 1,172 | |
| Overall Study | NOT COMPLETED | Dabigatran 150 mg | 125 | |
| Overall Study | NOT COMPLETED | Warfarin | 116 |
Source ClinicalTrials.gov
Adverse events502
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 | Pain in extremity | Musculoskeletal and connective tissue disorders | Dabigatran 150 mg | 75 | 1,280 | |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Warfarin | 69 | 1,288 | |
| other | Headache | Nervous system disorders | Dabigatran 150 mg | 57 | 1,280 | |
| other | Headache | Nervous system disorders | Warfarin | 70 | 1,288 | |
| serious | Anaemia | Blood and lymphatic system disorders | Dabigatran 150 mg | 3 | 1,280 | |
| serious | Anaemia | Blood and lymphatic system disorders | Warfarin | 2 | 1,288 | |
| serious | Coagulopathy | Blood and lymphatic system disorders | Dabigatran 150 mg | 0 | 1,280 | |
| serious | Coagulopathy | Blood and lymphatic system disorders | Warfarin | 1 | 1,288 | |
| serious | Febrile neutropenia | Blood and lymphatic system disorders | Dabigatran 150 mg | 0 | 1,280 | |
| serious | Febrile neutropenia | Blood and lymphatic system disorders | Warfarin | 1 | 1,288 |
1 to 10 of 502Source ClinicalTrials.gov
See all 502 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dabigatran 150 mg | ||
| Total, all-cause mortality | Warfarin | ||
| Total, other adverse events | Dabigatran 150 mg | 124 | 1,280 |
| Total, other adverse events | Warfarin | 126 | 1,288 |
| Total, serious adverse events | Dabigatran 150 mg | 156 | 1,280 |
| Total, serious adverse events | Warfarin | 153 | 1,288 |
Source ClinicalTrials.gov
Papers3
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 |
|---|
| Dabigatran 150 mg vs Warfarin: 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/NCT00680186
GET https://conductscience.org/api/trials/v1/NCT00680186/results?page=2