At a glance
ClinicalIndex Comparison Record- ✓Scheduled for primary, unilateral elective total knee replacement
- ✓Age ≥18 years
- ✓Body weight ≥40 kg
- ✕History of bleeding diathesis
- ✕Coagulation disorders that put patient at excessive risk for bleeding
- ✕Major surgery or trauma (e.g. hip fracture) within the last 3 months
- ✕Uncontrolled hypertension or myocardial infarction within the last 3 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Randomized, Parallel-group, Double-blind, Active Controlled Study to Investigate the Efficacy and Safety of Two Different Dose Regimens (75mg Day 1 Followed by 150 mg Day 2-completion, and 110 mg Day 1 Followed by 220 mg Day 2-completion) of Dabigatran Etexilate Administered Orally (Capsules), Compared to Enoxaparin 30 mg Twice a Day Subcutaneous for 12 - 15 Days in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Knee Replacement Surgery
In Brief
A Phase 3 clinical trial evaluating Dabigatran Dose 1 - day 2 to completion, Dabigatran Dose 1 - day 1, and 3 other interventions for Arthroplasty, Replacement, Knee and Thromboembolism. Completed, enrolled 2,615 participants across 94 sites in 4 countries.
Detailed Summary
To determine the comparative efficacy and safety of two different doses (75mg day 1 followed by 150 mg day 2-completion, and 110 mg day 1 followed by 220 mg day 2-completion) of dabigatran administered orally (capsules), compared to enoxaparin 30 mg twice a day subcutaneous, in prevention of venous thromboembolism in patients with primary elective total knee replacement surgery
Study Details
Timeline
Interventions
low dose regimen taken once daily
low dose regimen taken once daily
high dose regimen taken once daily
high dose regimen taken once daily
30 mg subcutaneously twice daily