Trial · NCT00291330
Efficacy and Safety of Dabigatran Compared to Warfarin for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism
NCT00291330, Phase 3, Completed, Boehringer Ingelheim; results first posted 2011-02-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Dabigatran Compared to Warfarin for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism. Trials, record NCT00291330. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00291330
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Dabigatran Compared to Warfarin for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism
- NCT number
- NCT00291330
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,564 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Thromboembolism
- Interventions
- dabigatran etexilate 150 mg, warfarin (INR 2-3)
- First posted
- 2006-02-14
- Last updated
- 2014-06-06
- Other registries' IDs
- eudract:2005-001999-12
- Results first posted
- 2011-02-11
Source ClinicalTrials.gov
Registered outcomes9
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 post treatment period. 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 post treatment period. 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 post treatment period. 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 | 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 - related deaths which occured from randomisation to end of post treatment period. 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 (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 post treatment period. 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 Bleeding Events | From first intake of study drug to last intake of study drug + 6 days washout (washout time can be reduced until 0 day if the patient takes an other anti-coagulant therapy on and after last intake of active study drug) | Major bleeding events (MBE) were 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) was defined as * spontaneous skin hematoma \>=25 cm² * spontaneous nose bleed \>5 min * macroscopic hematuria spontaneous or \>24 hours if associated with an intervention * spontaneous rectal bleeding (more than spotting on toilet paper) * 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 end of study conduct | Any ACS occurring during the conduct of the study (centrally adjudicated as definite). Counts of patients having a centrally adjudicated definite ACS during intake of active study drug, after stopping active study drug and before or without intake of active study drug, according to treatment group. 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 | Laboratory Analyses | From first intake of study drug to last intake of study drug + 6 days washout (washout time can be reduced until 0 day if the patient takes an other anti-coagulant therapy on and after last intake of active study drug) | Frequency of patients with possible clinically significant abnormalities. |
Source ClinicalTrials.gov
Outcomes9
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. | 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 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. | 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 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. | 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 Who Died Due to VTE | 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. | 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 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. | 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 Bleeding Events | From first intake of study drug to last intake of study drug + 6 days washout (washout time can be reduced until 0 day if the patient takes an other anti-coagulant therapy on and after last intake of active study drug) | 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 end of study conduct | 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 | Laboratory Analyses | From first intake of study drug to last intake of study drug + 6 days washout (washout time can be reduced until 0 day if the patient takes an other anti-coagulant therapy on and after last intake of active study drug) | 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 |
Source ClinicalTrials.gov
Results 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 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) | 27 | 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) | 32 | Participants | |
| Number of Participants With Recurrent Symptomatic VTE and All Deaths | Dabigatran 150 mg | Participants with event (up to day 180) | 48 | Participants | |
| Number of Participants With Recurrent Symptomatic VTE and All Deaths | Warfarin | Participants with event (up to day 180) | 44 | Participants | |
| Number of Participants With Recurrent Symptomatic VTE and All Deaths | Dabigatran 150 mg | Participants with event (up to end of ptp) | 55 | Participants | |
| Number of Participants With Recurrent Symptomatic VTE and All Deaths | Warfarin | Participants with event (up to end of ptp) | 53 | Participants | |
| Number of Participants With Recurrent Symptomatic DVT | Dabigatran 150 mg | Participants with event (up to day 180) | 16 | participants | |
| Number of Participants With Recurrent Symptomatic DVT | Warfarin | Participants with event (up to day 180) | 18 | participants |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 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 | 1,273 | |
| Overall Study | STARTED | Warfarin | 1,266 | |
| Overall Study | COMPLETED | Dabigatran 150 mg | 1,172 | |
| Overall Study | COMPLETED | Warfarin | 1,169 | |
| Overall Study | NOT COMPLETED | Dabigatran 150 mg | 101 | |
| Overall Study | NOT COMPLETED | Warfarin | 97 |
Source ClinicalTrials.gov
Adverse events526
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 | 63 | 1,273 | |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Warfarin | 69 | 1,266 | |
| other | Headache | Nervous system disorders | Dabigatran 150 mg | 78 | 1,273 | |
| other | Headache | Nervous system disorders | Warfarin | 87 | 1,266 | |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Dabigatran 150 mg | 35 | 1,273 | |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Warfarin | 78 | 1,266 | |
| serious | Anaemia | Blood and lymphatic system disorders | Dabigatran 150 mg | 5 | 1,273 | |
| serious | Anaemia | Blood and lymphatic system disorders | Warfarin | 2 | 1,266 | |
| serious | Febrile neutropenia | Blood and lymphatic system disorders | Dabigatran 150 mg | 1 | 1,273 | |
| serious | Febrile neutropenia | Blood and lymphatic system disorders | Warfarin | 0 | 1,266 |
1 to 10 of 526Source ClinicalTrials.gov
See all 526 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 | 163 | 1,273 |
| Total, other adverse events | Warfarin | 209 | 1,266 |
| Total, serious adverse events | Dabigatran 150 mg | 165 | 1,273 |
| Total, serious adverse events | Warfarin | 150 | 1,266 |
Source ClinicalTrials.gov
Papers4
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/NCT00291330
GET https://conductscience.org/api/trials/v1/NCT00291330/results?page=2