RE-MODEL Dabigatran Etexilate 150mg or 220mg Once Daily (o.d.) Versus (v.s.) Enoxaparin 40mg o.d. for Prevention of Thrombosis After Knee Surgery

Phase 3

Completed

• Conditions: Arthroplasty, Replacement, Knee; Thromboembolism
• Interventions: Drug: dabigatran etexilate; Drug: enoxaparin

• Registration Number: NCT00168805
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

A phase III, randomised, parallel-group, double-blind, active controlled study to investigate the ef ficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsule s \[150 or 220 mg once daily starting with a half dose (i.e.75 or 110 mg) on the day of surgery\] comp ared to subcutaneous enoxaparin 40 mg once daily for 6 to 10 days, in prevention of venous thromboem bolism in patients with primary elective total knee replacement surgery. RE-MODEL (Thromboembolism prevention after knee surgery)

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Primary Completion: 2006-05
• Results First Submitted: 2010-11-18
• Results First Submitted QC: 2010-11-18
• Results First Posted: 2010-12-17
• Status Verified: 2014-02
• Last Update Submitted: 2014-05-08
• Last Update Posted: 2014-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2101

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dabigatran etexilate 220 mg	dabigatran etexilate	220 mg once daily
dabigatran etexilate 150 mg	dabigatran etexilate	150 mg once daily
enoxaparin	enoxaparin	40 mg once daily

Primary Outcome Measures

Name	Time	Method
Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period	First administration until 6-10 days	Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression 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 Proximal Deep Vein Thrombosis During Treatment Period	First administration until 6-10 days	Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee
Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period	First administration until 6-10 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	First administration until 6-10 days	Total Deep Vein Thrombosis as adjudicated by the VTE events committee
Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period	First administration until 6-10 days	Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee
Number of Participants With Pulmonary Embolism During Treatment Period	First administration until 6-10 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 Who Died During Treatment Period	First administration until 6-10 days	All cause death, 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 bilateral venography), symptomatic DVT (confirmed by venous compression 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	First administration until 6-10 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 greater than or equal to 25 cm²; * wound hematoma greater than or equal to 100 cm²; * spontaneous nose bleed lasting longer than 5 min; * macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention; * spontaneous rectal bleeding (more than a spot on toilet paper); * gingival bleeding lasting longer than 5 min; * any other bleeding event considered clinically relevant by the investigator; Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above.
Blood Transfusion	Day 1	Blood transfusion for treated and operated patients on Day of surgery.
Laboratory Analyses	First administration to end of study	Frequency of patients with possible clinically significant abnormalities.

Trial Locations

Locations (105)

1160.25.06108 Boehringer Ingelheim Investigational Site; 🇦🇺 Garren, Australian Capital Territory, Australia

1160.25.06106 Boehringer Ingelheim Investigational Site; 🇦🇺 Kogarah, New South Wales, Australia

1160.25.06110 Boehringer Ingelheim Investigational Site; 🇦🇺 Lismore, New South Wales, Australia

1160.25.06105 Boehringer Ingelheim Investigational Site; 🇦🇺 Bedford Park, South Australia, Australia

1160.25.06107 Boehringer Ingelheim Investigational Site; 🇦🇺 Toorak Gardens, South Australia, Australia

1160.25.06109 Boehringer Ingelheim Investigational Site; 🇦🇺 Woodville, South Australia, Australia

1160.25.06104 Boehringer Ingelheim Investigational Site; 🇦🇺 Box Hill, Victoria, Australia

1160.25.06102 Boehringer Ingelheim Investigational Site; 🇦🇺 Clayton, Victoria, Australia

1160.25.06101 Boehringer Ingelheim Investigational Site; 🇦🇺 Malvern, Victoria, Australia

1160.25.06103 Boehringer Ingelheim Investigational Site; 🇦🇺 Ringwood East, Victoria, Australia

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