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 Ingelheim

Status and phase: Completed; Phase 3

Conditions: Thromboembolism; Arthroplasty, Replacement, Knee

Treatments: Drug: enoxaparin; Drug: dabigatran etexilate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00168805

2004-001317-34 (EudraCT Number)

1160.25

Details and patient eligibility

About

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)

Enrollment: 2,101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,101 participants in 3 patient groups

dabigatran etexilate 220 mg

Experimental group

Description:

220 mg once daily

Treatment:

Drug: dabigatran etexilate

Drug: dabigatran etexilate

dabigatran etexilate 150 mg

Experimental group

Description:

150 mg once daily

Treatment:

Drug: dabigatran etexilate

Drug: dabigatran etexilate

enoxaparin

Active Comparator group

Description:

40 mg once daily

Treatment:

Drug: enoxaparin