• Total venous thromboembolic events (VTE) and all cause mortality during the treatment period. Total VTE is defined as the composite incidence of proximal and distal deep venous thrombosis (DVT), symptomatic DVT and pulmonary embolism (PE).
  

• Efficacy: Major VTE (proximal DVT and PE) and VTE related mortality proximal DVT total DVT symptomatic DVT PE death Safety: Bleeds blood loss + transfusion adverse events (AE) discontinuation due to AE laboratory physical exam.
  

This is a phase III randomised, parallel group, double-blind, active controlled (double dummy) study to investigate the efficacy and safety of two different dose regimens of orally administered dabiga tran etexilate capsules [150 or 220 mg once daily starting with half dose (i.e. 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.

Study Hypothesis:

This trial aims to demonstrate therapeutic equivalence (non-inferiority) of dabi gatran compared with enoxaparin by showing that the rate of total venous thrombo embolic events (VTE) plus all-cause mortality in dabigatran treatment does not e xceed the VTE rate after enoxaparin treatment by more than 7.7%. The correspondi ng null hypotheses of interest are that the difference in rates of total VTE plu s all-cause mortality in dabigatran treatment versus enoxaparin is greater than 7.7%.

Comparison(s):

For the primary comparison the rates of total venous thromboembolic events (VTE) and all cause mortality during the treatment period will be compared. Total VTE is defined as the composite incidence of proximal and distal deep venous thromb osis (DVT), symptomatic DVT and pulmonary embolism (PE).