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

Boehringer Ingelheim logo

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

Trial contacts and locations

116

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Data sourced from clinicaltrials.gov

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