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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Dabigatran; Enoxaparin

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