Dabigatran Etexilate Compared With Enoxaparin in Prevention of Venous Thromboembolism (VTE) Following Total Hip Arthroplasty

Phase 3

Completed

Conditions: Venous Thromboembolism

Interventions: Drug: Enoxaparin
Drug: Dabigatran etexilate

Registration Number: NCT00657150

Lead Sponsor: Boehringer Ingelheim

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 2055

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enoxaparin	Enoxaparin	40 mg once daily
Dabigatran etexilate	Dabigatran etexilate	220 mg once daily

Primary Outcome Measures

Name	Time	Method
Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period	28-35 days	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.

Secondary Outcome Measures

Name	Time	Method
Volume of Blood Loss	Day 1	Volume of blood loss for treated and operated patients during surgery.
Number of Participants With Pulmonary Embolism During Treatment Period	28-35 days	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
Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period	28-35 days	Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee
Number of Participants With Total Deep Vein Thrombosis During Treatment Period	28-35 days	Total Deep Vein Thrombosis as adjudicated by the VTE events committee
Number of Participants Who Died During Treatment Period	28-35 days	All cause death, as adjudicated by the VTE events committee
Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period	28-35 days	Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee
Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period	28-35 days	Symptomatic Deep Vein Thrombosis, confirmed by venous duplex, ultrasound, venography or autopsy, and as adjudicated by the VTE events committee
Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period	3 months	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).
Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period	28-35 days	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.
Blood Transfusion	Day 1	Number of treated and operated patients with required blood transfusion on day of surgery.
Laboratory Analyses	First administration to end of study	Frequency of patients with possible clinically significant abnormalities.

Trial Locations

Locations (108): 1160.64.01005 Boehringer Ingelheim Investigational Site
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La Jolla, California, United States
1160.64.01010 Boehringer Ingelheim Investigational Site
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Aurora, Colorado, United States
1160.64.01009 Boehringer Ingelheim Investigational Site
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Englewood, Colorado, United States
1160.64.01012 Boehringer Ingelheim Investigational Site
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Clearwater, Florida, United States
1160.64.01006 Boehringer Ingelheim Investigational Site
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Lexington, Kentucky, United States
1160.64.01003 Boehringer Ingelheim Investigational Site
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Missoula, Montana, United States
1160.64.01007 Boehringer Ingelheim Investigational Site
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Charleston, South Carolina, United States
1160.64.01013 Boehringer Ingelheim Investigational Site
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Conway, South Carolina, United States
1160.64.01002 Boehringer Ingelheim Investigational Site
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Houston, Texas, United States
1160.64.01011 Boehringer Ingelheim Investigational Site
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Spokane, Washington, United States
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1160.64.01005 Boehringer Ingelheim Investigational Site
🇺🇸La Jolla, California, United States