At a glance
ClinicalIndex Comparison Record- ✓Patients aged 18 years or older
- ✓Scheduled to undergo primary, unilateral, elective total knee replacement
- ✕Excessive risk of bleeding (history of bleeding diathesis, major surgery/trauma within 3 months, hemorrhagic stroke, intracranial pathologies)
- ✕Clinically relevant bleeding or gastric/duodenal ulcer within 6 months
- ✕Anticoagulant treatment within 7 days prior to surgery or anticipated need during study
- ✕Thrombocytopenia
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
RE-MODEL (Thromboembolism Prevention After Knee Surgery). Two Different Dose Regimens of Orally Administered Dabigatran Etexilate Capsules [150 or 220 mg Once Daily Starting With a Half Dose (i.e.75 or 110 mg) on the Day of Surgery] Compared to Subcutaneous Enoxaparin 40 mg Once Daily for 6-10 Days
In Brief
A Phase 3 clinical trial evaluating enoxaparin and dabigatran etexilate for Arthroplasty, Replacement, Knee and Thromboembolism. Completed, enrolled 2,101 participants across 105 sites in 15 countries.
Detailed Summary
A phase III, randomised, parallel-group, double-blind, active controlled study to investigate the ef ficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsule s \[150 or 220 mg once daily starting with a half dose (i.e.75 or 110 mg) on the day of surgery\] comp ared to subcutaneous enoxaparin 40 mg once daily for 6 to 10 days, in prevention of venous thromboem bolism in patients with primary elective total knee replacement surgery. RE-MODEL (Thromboembolism prevention after knee surgery)
Study Details
Timeline
Interventions
40 mg once daily
150 mg once daily
220 mg once daily