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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000069550

Acronym

RECORD 2

Enrollment

2451

Registered

2006-02-20

Start date

2006-02-19

Completion date

2007-02-27

Last updated

2020-02-17

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

Conditions

None listed

Brief 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.

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 - 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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients scheduled for elective total hip replacement.- Patients’ written informed consent for participation after receiving detailed written and oral information previous to any study specific procedures.

Exclusion criteria

Planned, staged total bilateral hip replacement.- Active bleeding or high risk of bleeding contraindicating treatment with low molecular weight heparin.- Contraindication listed in the labeling or conditions precluding patient treatment with enoxaparin.- Conditions prohibiting bilateral venography (amputation of one leg, allergy to contrast media).- Pregnant and breast-feeding women. Women with child-bearing potential not using adequate birth control method. - Drug or alcohol abuse.- Concomitant use of HIV-protease inhibitors.- Therapy with another investigational product within 30 days prior start of study.- Planned intermittent pneumatic compression during active treatment period.- Concomitant participation in another trial or study.- Ongoing oral anticoagulant therapy that cannot be stopped in the opinion of the investigator.

Outcome results