Dose-confirmatory Bridging Study in Total Knee Replacement

Bayer

Status and phase: Completed; Phase 3

Conditions: Venous Thromboembolism

Treatments: Drug: Enoxaparin; Drug: Rivaroxaban (BAY59-7939)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01206972

14398

Details and patient eligibility

About

The objective of this dose-confirmatory bridging study is to investigate the safety and efficacy of rivaroxaban 5 to 10 mg once-daily (od) dosing in the prevention of venous thromboembolism (VTE) in Japanese patients undergoing elective total knee replacement (TKR) and to confirm the extrapolability of global data to Japanese patients by comparing with data from overseas phase III study (RECORD 3 - Study 11356) and phase II studies.

Enrollment: 302 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female patients aged 20 years or above
• Patients undergoing elective TKR (the first replacement of the applicable knee joint)
• Patients' written informed consent to participation after receiving detailed verbal and written information on any study specific procedures in advance

Exclusion criteria

• Planned, staged major orthopedic surgery within 3 months prior to elective TKR or during this study

• History of clinically significant active bleeding (e.g. intracranial bleeding, gastrointestinal bleeding*), or high bleeding risk

  *: within 3 months prior to elective TKR for gastrointestinal bleeding

• Subjects with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk

• Severe impaired renal function (CLCR calculated by Cockcroft-Gault formula: <30 mL/min)

• Conditions prohibiting bilateral venography (e.g. amputation of 1 leg, allergy to contrast media)

• Ongoing anticoagulant therapy (e.g. warfarin, heparins and Factor Xa inhibitors other than study medication) that cannot be stopped (in the opinion of the investigator/sub investigator)

• Subjects for whom epidural catheters are expected to be left in for longer than 18 hours post-operatively

• Planned intermittent pneumatic compression during treatment period.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

302 participants in 4 patient groups

Arm 1

Experimental group

Treatment:

Drug: Rivaroxaban (BAY59-7939)

Drug: Rivaroxaban (BAY59-7939)

Drug: Rivaroxaban (BAY59-7939)

Arm 2

Experimental group

Treatment:

Drug: Rivaroxaban (BAY59-7939)

Drug: Rivaroxaban (BAY59-7939)

Drug: Rivaroxaban (BAY59-7939)

Arm 3

Experimental group

Treatment:

Drug: Rivaroxaban (BAY59-7939)

Drug: Rivaroxaban (BAY59-7939)

Drug: Rivaroxaban (BAY59-7939)

Arm 4

Active Comparator group

Treatment:

Drug: Enoxaparin