A Phase 3 interventional study of Dabigatran and Warfarin in Thromboembolism, sponsored by Boehringer Ingelheim. Completed at 275 sites in 33 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-19.
Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Treatment
The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate administered orally and warfarin (International Normalized Ratio (INR) of 2.0-3.0) for the long-term treatment and secondary prevention of symptomatic venous thromboembolism in patients who have been successfully treated with standard doses of an approved anticoagulant for three to twelve months for confirmed acute symptomatic Venous Thrombo-embolism.
818 studies on the registry are indexed under Thromboembolism; 98 are open to participants now.
This study's enrollment of 2,867 is above the median of 196 across 436 interventional studies indexed under Thromboembolism.
Browse Thromboembolism studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria:
Inclusion_Criteria
Exclusion criteria:
Exclusion_Criteria
Patient to receive 1 capsule containing dabigatran 150 mg twice daily plus placebo tablets for warfarin as decided by sham INR measurements
Drug: Dabigatran
Patient to receive warfarin tablets to target INR 2.0-3.0 plus placebo capsules for dabigatran twice daily
Drug: Warfarin
Dabigatran 150 mg BID (twice daily)
Warfarin dosed individually to maintain INR 2.0-3.0
Composite of Recurrent VTE or VTE Death at 36 Months
Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE.
Time frame: 36 months
Composite of Recurrent VTE or VTE Death at 18 Months
Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE.
Time frame: 18 months
Composite of Recurrent VTE or All Cause Death at 36 Months
Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation.
Time frame: 36 months
Composite of Recurrent VTE or All Cause Death at 18 Months
Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation.
Time frame: 18 months
Deep Vein Thrombosis (DVT) at 36 Months
Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation.
Time frame: 36 months
DVT at 18 Months
Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation.
Time frame: 18 months
Symptomatic Pulmonary Embolism (PE) at 36 Months
Symptomatic pulmonary embolism (PE) at 36 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography.
Time frame: 36 months
Symptomatic Pulmonary Embolism (PE) at 18 Months
Symptomatic pulmonary embolism (PE) at 18 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography.
Time frame: 18 months
Deaths Related to VTE at 36 Months
Deaths related to VTE (i.e. fatal PE) at 36 Months. Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way.
Time frame: 36 months
Deaths Related to VTE at 18 Months
Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way.
Time frame: 18 months
Deaths of All Causes at 36 Months
Deaths of all causes at 36 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments.
Time frame: 36 months
Deaths of All Causes at 18 Months
Deaths of all causes at 18 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments.
Time frame: 18 months
Number of Participants With Bleeding Events
MBE (major bleeding event) if it fulfilled at least one of the following criteria * 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. Minor bleeding event was any bleeding that did not fulfil any of the criteria for MBEs CRBE (clinically relevant bleeding event) if it is a minor bleeding events which fulfilled at least one of the following criteria * Spontaneous skin haematoma ≥25 cm2 * Spontaneous nose bleed \>5 min duration * Macroscopic haematuria, either spontaneous or, if associated with an intervention, lasting \>24 h * Spontaneous rectal bleeding * Gingival bleeding \>5 min * Bleeding leading to hospitalisation or requiring surgical treatment * Bleeding leading to a transfusion of \<2 units of whole blood or red cells * Any other bleeding event considered clinically relevant by the investigator
Time frame: first intake of study drug until 6 days following last intake of study drug
Laboratory Analysis
Patients with LFT (liver function tests) increases of possible clinical significance during treatment. Increases of possible clinical significance were defined as: ≥3 x ULN (AST, ALT), ≥2 x ULN (AP), and ≥2 mg/dL (total bilirubin). Only patients with a baseline value which was not of possible clinical significance (or without any baseline value) could have a PCSA (Possible clinically significant abnormality).
Time frame: 18 months + 30 days follow up
Number of Participants With Definite Acute Coronary Syndrome (ACS)
All suspected ACS occurring during the trial were to be recorded on the CRF and were to be centrally adjudicated by an independent ACS/AC in a treatment-blinded manner.
Time frame: day of first study drug intake until last day of study drug intake; from the day after last intake of study drug until trial termination
| Milestone | Dabigatran | Warfarin |
|---|---|---|
| Started | 1430 | 1426 |
| Completed | 1154 | 1145 |
| Not completed | 276 | 281 |
| Withdrew: Adverse event | 147 | 129 |
| Withdrew: Protocol violation | 23 | 34 |
| Withdrew: Lost to follow-up | 2 | 6 |
| Withdrew: Withdrawal by subject | 64 | 58 |
| Withdrew: Other reason (not specified) | 40 | 54 |
Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE.
| Participants | Dabigatran | Warfarin |
|---|---|---|
| Number of participants with event | 26 | 18 |
| Number of participants with no event | 1404 | 1408 |
Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE.
| Participants | Dabigatran | Warfarin |
|---|---|---|
| Number of participants with event | 22 | 17 |
| Number of participants with no event | 1408 | 1409 |
Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation.
| Participants | Dabigatran | Warfarin |
|---|---|---|
| Number of participants with event | 42 | 36 |
| Number of participants with no event | 1388 | 1390 |
Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation.
| Participants | Dabigatran | Warfarin |
|---|---|---|
| Number of participants with event | 36 | 32 |
| Number of participants with no event | 1394 | 1394 |
Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation.
| Participants | Dabigatran | Warfarin |
|---|---|---|
| Number of participants with event | 17 | 13 |
| Number of participants with no event | 1413 | 1413 |
Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation.
| Participants | Dabigatran | Warfarin |
|---|---|---|
| Number of participants with event | 15 | 12 |
| Number of participants with no event | 1415 | 1414 |
Symptomatic pulmonary embolism (PE) at 36 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography.
| Participants | Dabigatran | Warfarin |
|---|---|---|
| Number of participants with event | 10 | 5 |
| Number of participants with no event | 1420 | 1421 |
Symptomatic pulmonary embolism (PE) at 18 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography.
| Participants | Dabigatran | Warfarin |
|---|---|---|
| Number of participants with event | 8 | 5 |
| Number of participants with no event | 1422 | 1421 |
Deaths related to VTE (i.e. fatal PE) at 36 Months. Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way.
| Participants | Dabigatran | Warfarin |
|---|---|---|
| Number of participants with event | 1 | 1 |
| Number of participants with no event | 1429 | 1425 |
Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way.
| Participants | Dabigatran | Warfarin |
|---|---|---|
| Number of participants with event | 1 | 1 |
| Number of participants with no event | 1429 | 1425 |
Deaths of all causes at 36 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments.
| Participants | Dabigatran | Warfarin |
|---|---|---|
| Number of participants with event | 17 | 19 |
| Number of participants with no event | 1413 | 1407 |
Deaths of all causes at 18 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments.
| Participants | Dabigatran | Warfarin |
|---|---|---|
| Number of participants with event | 15 | 16 |
| Number of participants with no event | 1415 | 1410 |
MBE (major bleeding event) if it fulfilled at least one of the following criteria * 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. Minor bleeding event was any bleeding that did not fulfil any of the criteria for MBEs CRBE (clinically relevant bleeding event) if it is a minor bleeding events which fulfilled at least one of the following criteria * Spontaneous skin haematoma ≥25 cm2 * Spontaneous nose bleed \>5 min duration * Macroscopic haematuria, either spontaneous or, if associated with an intervention, lasting \>24 h * Spontaneous rectal bleeding * Gingival bleeding \>5 min * Bleeding leading to hospitalisation or requiring surgical treatment * Bleeding leading to a transfusion of \<2 units of whole blood or red cells * Any other bleeding event considered clinically relevant by the investigator
| participants | Dabigatran | Warfarin |
|---|---|---|
| patients with MBE | 13 | 25 |
| patients with MBE and /or CRBE | 80 | 145 |
| patients with any bleeding event | 277 | 373 |
Patients with LFT (liver function tests) increases of possible clinical significance during treatment. Increases of possible clinical significance were defined as: ≥3 x ULN (AST, ALT), ≥2 x ULN (AP), and ≥2 mg/dL (total bilirubin). Only patients with a baseline value which was not of possible clinical significance (or without any baseline value) could have a PCSA (Possible clinically significant abnormality).
| participants | Dabigatran | Warfarin |
|---|---|---|
| ALT increase | 26 | 30 |
| AST increase | 23 | 23 |
| Alkaline phosphatase | 9 | 14 |
| Total bilirubin | 9 | 8 |
All suspected ACS occurring during the trial were to be recorded on the CRF and were to be centrally adjudicated by an independent ACS/AC in a treatment-blinded manner.
| participants | Dabigatran | Warfarin |
|---|---|---|
| During intake of study drug, N=1430 , N=1415 | 12 | 2 |
| After stopping study drug, N=1426, N=1400 | 1 | 5 |
Collected over 18-month treatment period. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dabigatran | — | 227/1,430 (15.9%) | 409/1,430 (28.6%) |
| Warfarin | — | 224/1,426 (15.7%) | 415/1,426 (29.1%) |
| Post Dabigatran | — | 33/1,395 (2.4%) | 34/1,395 (2.4%) |
| Post Warfarin | — | 41/1,384 (3%) | 32/1,384 (2.3%) |
| Event | Dabigatran | Warfarin | Post Dabigatran | Post Warfarin |
|---|---|---|---|---|
| Deep vein thrombosisVascular disorders | 10/1430 | 6/1426 | 1/1395 | 2/1384 |
| Chest painGeneral disorders | 4/1430 | 9/1426 | 0/1395 | 2/1384 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 9/1430 | 3/1426 | 3/1395 | 2/1384 |
| Abdominal painGastrointestinal disorders | 4/1430 | 8/1426 | 1/1395 | 0/1384 |
| Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 5/1430 | 7/1426 | 1/1395 | 0/1384 |
| HaematuriaRenal and urinary disorders | 2/1430 | 6/1426 | 2/1395 | 0/1384 |
| Myocardial infarctionCardiac disorders | 6/1430 | 0/1426 | 0/1395 | 1/1384 |
| PneumoniaInfections and infestations | 6/1430 | 5/1426 | 0/1395 | 1/1384 |
| CellulitisInfections and infestations | 3/1430 | 5/1426 | 1/1395 | 0/1384 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 5/1430 | 3/1426 | 0/1395 | 1/1384 |
| Event | Dabigatran | Warfarin | Post Dabigatran | Post Warfarin |
|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 112/1430 | 127/1426 | 5/1395 | 8/1384 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 109/1430 | 110/1426 | 9/1395 | 6/1384 |
| HeadacheNervous system disorders | 84/1430 | 100/1426 | 4/1395 | 8/1384 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 46/1430 | 92/1426 | 7/1395 | 3/1384 |
| Oedema peripheralGeneral disorders | 76/1430 | 68/1426 | 8/1395 | 3/1384 |
| InfluenzaInfections and infestations | 75/1430 | 67/1426 | 2/1395 | 11/1384 |
| DiarrhoeaGastrointestinal disorders | 73/1430 | 51/1426 | 4/1395 | 3/1384 |
The FAS consisted of all randomised patients who were documented to have taken at least 1 dose of study drug.
| Age, Continuous(years) | Dabigatran | Warfarin | Total |
|---|---|---|---|
| Mean | 55.38 ± 14.99 | 53.90 ± 15.34 | 54.64 ± 15.18 |
| Age, Customized(participants) | Dabigatran | Warfarin | Total |
|---|---|---|---|
| >=18 to <40 years | 237 | 269 | 506 |
| >=40 to <50 years | 250 | 291 | 541 |
| >=50 to <65 years | 500 | 459 | 959 |
| >=65 to <75 years | 303 | 288 | 591 |
| >= 75 years | 140 | 119 | 259 |
| Sex: Female, Male(Participants) | Dabigatran | Warfarin | Total |
|---|---|---|---|
| Female | 559 | 555 | 1114 |
| Male | 871 | 871 | 1742 |
| Race/Ethnicity, Customized(Participants) | Dabigatran | Warfarin | Total |
|---|---|---|---|
| Not Hispanic/Latino | 1325 | 1317 | 2642 |
| Hispanic/Latino | 105 | 109 | 214 |
| Race/Ethnicity, Customized(Participants) | Dabigatran | Warfarin | Total |
|---|---|---|---|
| White | 1288 | 1284 | 2572 |
| Black | 29 | 28 | 57 |
| Asian | 113 | 114 | 227 |
| Height(cm) | Dabigatran | Warfarin | Total |
|---|---|---|---|
| Mean | 171.55 ± 9.73 | 171.95 ± 10.08 | 171.75 ± 9.90 |
| Weight(kg) | Dabigatran | Warfarin | Total |
|---|---|---|---|
| Mean | 86.09 ± 19.26 | 85.95 ± 18.87 | 86.02 ± 19.06 |
| Weight category(Participants) | Dabigatran | Warfarin | Total |
|---|---|---|---|
| < 50 kg | 10 | 5 | 15 |
| >= 50 to < 100 kg | 1120 | 1117 | 2237 |
| >= 100 kg | 299 | 300 | 599 |
| Missing | 1 | 4 | 5 |
5 further baseline measures are reported on the registry.
Showing the first 100 of 275 sites across 33 countries.
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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Boehringer Ingelheim