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

Boehringer Ingelheim2,101 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

2,101

Conditions

Arthroplasty, Replacement, Knee Thromboembolism

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria Inclusion criteria (selected): * Patients (18 years or older) scheduled to undergo a primary, unilateral, elect ive total knee replacement * Written Informed Consent Exclusion criteria Exclusion criteria (selected): * Patients with an excessive risk of bleeding, for example because of history of bleeding diathesis major surgery or trauma within the last 3 months history of haemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, arteriovenous (AV) malformation or aneurysm clinically relevant bleeding or gastric / duodenal ulcer within the last 6 months treatment with anticoagulants within 7 days prior to joint replacement surgery or anticipated need during the study treatment period thrombocytopenia. * Active malignant disease or current cytostatic treatment * Known severe renal insufficiency * Liver disease expected to have any potential impact on survival, or elevated aspartate aminotransferase (AST) or alanine transaminase (ALT) \> 2x upper limit of normal * Recent unstable cardiovascular disease or history of myocardial infarction within the last 3 months * Pre-menopausal women who are pregnant or nursing, or are of child-bearing pote ntial and are not practising or do not plan to continue practising acceptable me thods of birth control * Allergy to radio opaque contrast media or iodine, heparins (incl. heparin indu ced thrombocytopenia) or dabigatran * Contraindications to enoxaparin * Participation in a clinical trial during the last 30 days

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

Outcomes

Primary Outcomes

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 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.