A phase III randomised, parallel group, double-blind, active controlled study to investigate the efficacy and safety of oral 220 mg dabigatran etexilate (110 mg on the day of surgery followed by 220 mg once daily) compared to subcutaneous 40 mg enoxaparin once daily for 28-35 days in prevention of venous thromboembolism in patients following primary elective total hip arthroplasty. (RE-NOVATE II) - RE-NOVATE II

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-002630-11-NL

Enrollment

1920

Registered

2008-02-01

Start date

2008-04-07

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary VTE prevention in patients following total hip replacement surgery MedDRA version: 9.1 Level: LLT Classification code 10049909 Term: Venous thromboembolism prophylaxis

Interventions

Product Name: dabigatran etexilate Product Code: BIBR1048MS Pharmaceutical Form: Capsule, hard INN or Proposed INN: dabigatran etexilate Current Sponsor code: BI1048MS Other descriptive name: n.a. Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients scheduled to undergo primary, unilateral, elective total hip replacement. Male or female 18 years of age or older. Patients giving written informed consent for study participation. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: History of bleeding diathesis. Ongoing treatment for VTE. Clinically relevant bleeding (gastrointestinal, pulmonary, intraocular or urogenital bleeding). Liver disease expected to have any potential impact on survival. Known severe renal insufficiency (CrCl <30 ml/min). Pre-menopausal women who: a. Are pregnant. b. Are nursing. c. Are of child-bearing potential and are NOT practicing acceptable methods of birth control, or do NOT plan to continue practicing an acceptable method throughout the study.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to demonstrate the safety and efficacy of once daily 220 mg oral dabigatran etexilate compared to 40 mg subcutaneous enoxaparin administered once daily in preventing venous thromboembolism in patients following total hip replacement surgery. ;Secondary Objective: ;Primary end point(s): The primary efficacy endpoint of this study is the composite of total venous thromboembolic events (VTE) and all-cause mortality during the treatment period.	—

Measure

Time frame

Main Objective: The primary objective is to demonstrate the safety and efficacy of once daily 220 mg oral dabigatran etexilate compared to 40 mg subcutaneous enoxaparin administered once daily in preventing venous thromboembolism in patients following total hip replacement surgery. ;Secondary Objective: ;Primary end point(s): The primary efficacy endpoint of this study is the composite of total venous thromboembolic events (VTE) and all-cause mortality during the treatment period.

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Countries

Austria, Belgium, Czech Republic, Denmark, Finland, Germany, Hungary, Italy, Netherlands, Spain, Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026