Dabigatran Etexilate in Extended Venous Thromboembolism (VTE) Prevention After Hip Replacement Surgery

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Arthroplasty, Replacement, Hip; Thromboembolism

Treatments: Drug: enoxaparin; Drug: dabigatran etexilate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00168818

2004-001988-21 (EudraCT Number)

1160.48

Details and patient eligibility

About

The objective of this study is to determine the comparative efficacy and safety of two oral regimens of dabigatran etexilate, compared to a standard subcutaneous regimen of enoxaparin, in prevention of venous thromboembolism in patients with primary elective total hip replacement surgery.

Enrollment: 3,494 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, elective total hip 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, 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 AST or 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 potential and are not practising or do not plan to continue practising acceptable methods of birth control
• Allergy to radio opaque contrast media or iodine, heparins (incl. heparin induced 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

---

3,494 participants in 3 patient groups

dabigatran etexilate 75 mg

Experimental group

Description:

daily dose 150 mg once daily, half a dose on the day of surgery

Treatment:

Drug: dabigatran etexilate

Drug: dabigatran etexilate

dabigatran etexilate 110 mg

Experimental group

Description:

daily dose 220 mg once daily, half a dose on the day of surgery

Treatment:

Drug: dabigatran etexilate

Drug: dabigatran etexilate

enoxaparin

Active Comparator group

Description:

40 mg once daily

Treatment:

Drug: enoxaparin