CompletedPhase 3ACTRN12606000069550

REgulation of Coagulation in ORthopedic Surgery to prevent DVT and PE, controlled, double-blind, randomized study of BAY 59-7939 in the extended prevention of VTE in patients undergoing elective total hip replacement.

Regulation of Coagulation in Orthopedic Surgery to prevent Deep Venous Thrombosis and Pulmonary Embolism, controlled, double-blind, randomized study of BAY 59-7939 administered for 5 weeks compared with enoxaparin administered for 10 - 12 days in the extended prevention of Venous Thromboembolism in patients undergoing elective total hip replacement.


Sponsor

Bayer Australia Limited

Enrollment

2,500 participants

Start Date

Feb 19, 2006

Study Type

Interventional

Conditions

Summary

The purpose of this study is to assess if 10mg Bay 59-7939, taken once daily as a tablet, is safe and can help prevent blood clots forming after a hip replacement operation.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying: REgulation of Coagulation in ORthopedic Surgery to prevent DVT and PE, controlled, double-blind, randomized study of BAY 59-7939 in the extended prevention of VTE in patients undergoing elective total hip replacement. It may be open to adults aged 18 and older who meet certain criteria, including: Scheduled for elective total hip replacement. Participation typically involves medical assessments, possible treatment with the study intervention, and follow-up visits to track your health.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

The patients will be randomized to I treatment group. I. 10 mg od of Bay 59-7939 tablets active substance (10 mg tablet) from Day 1 to Day 35 plus a placebo syringe of enoxaparin from Day 0 - Da

The patients will be randomized to I treatment group. I. 10 mg od of Bay 59-7939 tablets active substance (10 mg tablet) from Day 1 to Day 35 plus a placebo syringe of enoxaparin from Day 0 - Day 12 Day 1 will be defined as the day of the elective total hip replacement. On Day 1 the first dose of BAY 59-7939 or matching placebo and the second dose of enoxaparin or matching placebo will be administered post-operatively 6-8 hours after wound closure. Active treatment period for the Enoxaparin arm is day 0 to day 12. The active treatment period for BAY 59-3979 arm is from Day 1 until day 35. On day 36 a bilateral ascending venography is mandatory for all patients. If symptoms of DVT occur earlier, an ultrasound may be allowed. If the DVT is confirmed by ultrasound, a bilateral ascending venography is mandatory for all patients. No further study medication will be administered after the venography. If symptoms of pulmonary embolism occur during the study (including follow-up of 30 days post study treatment) a lung scintigraphy with chest X-Ray or a spiral CT or a pulmonary angiography should be performed. Symptoms of DVT occurring during follow-up should be verified by ultrasound or venography.


Locations(1)

Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12606000069550