At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 3,494 enrolled
Drug / intervention
dabigatran etexilate +2 moredrug
Likely dose
Dabigatran etexilate 150 mg orally once daily (starting with 75 mg on day of surgery)AI-extracted
Key inclusion· 2
- ✓Age 18 years or older
- ✓Scheduled for primary, unilateral, elective total hip replacement
Key exclusion· 11
- ✕Excessive risk of bleeding including history of bleeding diathesis, major surgery/trauma within 3 months, or hemorrhagic stroke
- ✕Intracranial pathology: bleeding, neoplasm, AV malformation, or aneurysm
- ✕Clinically relevant bleeding or gastric/duodenal ulcer within 6 months
- ✕Anticoagulant treatment within 7 days prior to surgery or anticipated need during study
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Randomised, Parallel Group, Double-blind, Active Controlled Study to Investigate the Efficacy and Safety of Two Different Dose Regimens of Orally Administered Dabigatran Etexilate Capsules [150 or 220 mg Once Daily Starting With Half Dose (75 or 110 mg) on the Day of Surgery] Compared to Subcutaneous Enoxaparin 40 mg Once Daily for 28-35 Days, in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip Replacement Surgery. RE-NOVATE (Extended Thromboembolism Prevention After Hip Surgery)
In Brief
A Phase 3 clinical trial evaluating dabigatran etexilate and enoxaparin for Thromboembolism and Arthroplasty, Replacement, Hip. Completed, enrolled 3,494 participants across 116 sites in 16 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThromboembolism, Arthroplasty, Replacement, Hip
CountriesAustralia, Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, South Africa, Spain, Sweden
Collaborators--
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2004
First PostedSep 2005
Primary CompletionJul 2006
TodayJul 2026
First PostedSep 15, 2005
Enrollment StartNov 1, 2004
Primary CompletionJul 1, 2006
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 20.8 years ago
Interventions
dabigatran etexilatedrug
daily dose 150 mg once daily, half a dose on the day of surgery
dabigatran etexilatedrug
daily dose 150 mg once daily, half a dose on the day of surgery
enoxaparindrug
40 mg once daily