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)
Overview
- Phase
- Phase 3
- Intervention
- dabigatran etexilate
- Conditions
- Thromboembolism
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 3494
- Locations
- 116
- Primary Endpoint
- Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
dabigatran etexilate 75 mg
daily dose 150 mg once daily, half a dose on the day of surgery
Intervention: dabigatran etexilate
dabigatran etexilate 110 mg
daily dose 220 mg once daily, half a dose on the day of surgery
Intervention: dabigatran etexilate
enoxaparin
40 mg once daily
Intervention: enoxaparin
Outcomes
Primary Outcomes
Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period
Time Frame: First administration until 31-38 days
Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy). All of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients.
Secondary Outcomes
- Death During Treatment Period(First administration until 31-38 days)
- Pulmonary Embolism During Treatment Period(First administration until 31-38 days)
- Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period(First administration until 31-38 days)
- Proximal Deep Vein Thrombosis During Treatment Period(First administration until 31-38 days)
- Total Deep Vein Thrombosis During Treatment Period(First administration until 31-38 days)
- Symptomatic Deep Vein Thrombosis During Treatment Period(First administration until 31-38 days)
- Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period(end of treatment to day 91±7)
- Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period(First administration until 31-38 days)
- Blood Transfusion(Day 1)
- Volume of Blood Loss(Day 1)
- Laboratory Analyses(First administration to end of study)