A Phase 3 interventional study of Enoxaparin and Dabigatran etexilate in Venous Thromboembolism, sponsored by Boehringer Ingelheim. Completed at 108 sites in 19 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-02.
Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Prevention
The primary objective of the trial is to demonstrate non-inferiority of 220 mg oral dabigatran etexilate compared to 40 mg subcutaneous enoxaparin administered once daily. Safety and efficacy will be compared between the treatment groups.
818 studies on the registry are indexed under Thromboembolism; 98 are open to participants now.
This study's enrollment of 2,055 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.
Exclusion criteria:
Pre-menopausal women (last menstruation within 1 year prior to signing informed consent) who:
220 mg once daily
Drug: Dabigatran etexilate
40 mg once daily
Drug: Enoxaparin
40 mg once daily
220 mg once daily
Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period
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.
Time frame: 28-35 days
Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period
Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee
Time frame: 28-35 days
Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period
Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee
Time frame: 28-35 days
Number of Participants With Total Deep Vein Thrombosis During Treatment Period
Total Deep Vein Thrombosis as adjudicated by the VTE events committee
Time frame: 28-35 days
Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period
Symptomatic Deep Vein Thrombosis, confirmed by venous duplex, ultrasound, venography or autopsy, and as adjudicated by the VTE events committee
Time frame: 28-35 days
Number of Participants With Pulmonary Embolism During Treatment Period
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
Time frame: 28-35 days
Number of Participants Who Died During Treatment Period
All cause death, as adjudicated by the VTE events committee
Time frame: 28-35 days
Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period
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).
Time frame: 3 months
Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period
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.
Time frame: 28-35 days
Blood Transfusion
Number of treated and operated patients with required blood transfusion on day of surgery.
Time frame: Day 1
Volume of Blood Loss
Volume of blood loss for treated and operated patients during surgery.
Time frame: Day 1
Laboratory Analyses
Frequency of patients with possible clinically significant abnormalities.
Time frame: First administration to end of study
The treatment period is from first administration of study medication, until 3 days after last administration of study medication. Treatment duration is planned for 28 - 35 days. The study period is from first administration of study medication until day 84 - 91.
| Milestone | Dabigatran 220mg | Enoxaparin |
|---|---|---|
| Started | 1010 | 1003 |
| Completed | 895 | 910 |
| Not completed | 115 | 93 |
| Withdrew: Adverse event | 19 | 10 |
| Withdrew: Non-compliant with protocol | 5 | 9 |
| Withdrew: Lost to follow-up | 2 | 0 |
| Withdrew: Withdrawal by subject | 51 | 36 |
| Withdrew: Other | 38 | 38 |
| Milestone | Dabigatran 220mg | Enoxaparin |
|---|---|---|
| Started | 1010 | 1003 |
| Completed | 903 | 906 |
| Not completed | 107 | 97 |
| Withdrew: Adverse event | 60 | 53 |
| Withdrew: Non-compliant with protocol | 10 | 9 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Withdrawal by subject | 23 | 20 |
| Withdrew: Other | 13 | 15 |
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.
| Participants | Dabigatran 220mg | Enoxaparin |
|---|---|---|
| Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period | 61 | 69 |
Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee
| Participants | Dabigatran 220mg | Enoxaparin |
|---|---|---|
| Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period | 18 | 33 |
Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee
| Participants | Dabigatran 220mg | Enoxaparin |
|---|---|---|
| Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period | 17 | 31 |
Total Deep Vein Thrombosis as adjudicated by the VTE events committee
| Participants | Dabigatran 220mg | Enoxaparin |
|---|---|---|
| Number of Participants With Total Deep Vein Thrombosis During Treatment Period | 60 | 67 |
Symptomatic Deep Vein Thrombosis, confirmed by venous duplex, ultrasound, venography or autopsy, and as adjudicated by the VTE events committee
| Participants | Dabigatran 220mg | Enoxaparin |
|---|---|---|
| Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period | 0 | 4 |
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
| Participants | Dabigatran 220mg | Enoxaparin |
|---|---|---|
| Number of Participants With Pulmonary Embolism During Treatment Period | 1 | 2 |
All cause death, as adjudicated by the VTE events committee
| Participants | Dabigatran 220mg | Enoxaparin |
|---|---|---|
| Number of Participants Who Died During Treatment Period | 0 | 1 |
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).
| Participants | Dabigatran 220mg | Enoxaparin |
|---|---|---|
| Total VTE and all-cause mortality | 2 | 4 |
| asymptomatic Deep Vein Thrombosis | 0 | 1 |
| symptomatic Deep Vein Thrombosis | 1 | 0 |
| Pulmonary Embolism | 1 | 2 |
| death | 0 | 1 |
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.
| Participants | Dabigatran 220mg | Enoxaparin |
|---|---|---|
| Major bleeding events | 14 | 9 |
| Major and clinically relevant bleeding events | 37 | 29 |
| Any bleeding events | 98 | 83 |
Number of treated and operated patients with required blood transfusion on day of surgery.
| participants | Dabigatran 220mg | Enoxaparin |
|---|---|---|
| Transfusions required | 246 | 237 |
| Missing | 4 | 7 |
Volume of blood loss for treated and operated patients during surgery.
| mL | Dabigatran 220mg | Enoxaparin |
|---|---|---|
| Volume of Blood Loss | 404.9 ± 259.67 | 411.0 ± 275.38 |
Frequency of patients with possible clinically significant abnormalities.
| participants | Dabigatran 220mg | Enoxaparin |
|---|---|---|
| AST increase N=(964;962) | 28 | 44 |
| AST decrease N=(964;962) | 0 | 0 |
| ALT increase N=(966;962) | 34 | 67 |
| ALT decrease N=(966;962) | 0 | 0 |
| Bilirubin increase N=(966;962) | 3 | 1 |
| Bilirubin decrease N=(966;962) | 0 | 0 |
Collected over 31 - 38 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dabigatran 220mg | — | 57/1,010 (5.6%) | 389/1,010 (38.5%) |
| Enoxaparin | — | 59/1,003 (5.9%) | 389/1,003 (38.8%) |
| Event | Dabigatran 220mg | Enoxaparin |
|---|---|---|
| Deep vein thrombosisVascular disorders | 4/1010 | 10/1003 |
| Renal failure acuteRenal and urinary disorders | 0/1010 | 4/1003 |
| Joint dislocationInjury, poisoning and procedural complications | 4/1010 | 3/1003 |
| Femur fractureInjury, poisoning and procedural complications | 2/1010 | 3/1003 |
| Wound secretionInjury, poisoning and procedural complications | 3/1010 | 1/1003 |
| ConstipationGastrointestinal disorders | 0/1010 | 2/1003 |
| NauseaGastrointestinal disorders | 0/1010 | 2/1003 |
| VomitingGastrointestinal disorders | 0/1010 | 2/1003 |
| Arthritis infectiveInfections and infestations | 0/1010 | 2/1003 |
| Urinary tract infectionInfections and infestations | 0/1010 | 2/1003 |
| Event | Dabigatran 220mg | Enoxaparin |
|---|---|---|
| NauseaGastrointestinal disorders | 162/1010 | 166/1003 |
| VomitingGastrointestinal disorders | 110/1010 | 94/1003 |
| ConstipationGastrointestinal disorders | 100/1010 | 102/1003 |
| PyrexiaGeneral disorders | 62/1010 | 80/1003 |
| Haemoglobin decreasedInvestigations | 56/1010 | 62/1003 |
| HypotensionVascular disorders | 61/1010 | 51/1003 |
Treated set
| Age, Continuous(Years) | Dabigatran 220mg | Enoxaparin | Total |
|---|---|---|---|
| Mean | 61.9 ± 11.5 | 62.0 ± 11.3 | 62.0 ± 11.4 |
| Sex: Female, Male(Participants) | Dabigatran 220mg | Enoxaparin | Total |
|---|---|---|---|
| Female | 541 | 501 | 1042 |
| Male | 469 | 502 | 971 |
| Body Mass Index N=(1003;992;1995)(kg/m^2) | Dabigatran 220mg | Enoxaparin | Total |
|---|---|---|---|
| Mean | 27.8 ± 4.8 | 27.8 ± 4.8 | 27.8 ± 4.8 |
Showing the first 100 of 108 sites across 19 countries.
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Boehringer Ingelheim