Trial Condition(s):
Venous Thromboembolism
Rivaroxaban (10mg) given once daily in patients undergoing Total Hip replacement compared to Enoxaparin
Bayer Identifier:
11354
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Цель исследования
The purpose of this study is to assess if 10 mg BAY 59-7939, taken once daily as a tablet, is safe and prevent blood clot which may form after total hip replacement operation.
Критерии включения
- Male and female patients aged 18 years or above - Patients scheduled for elective total hip replacement
Критерии исключения
- 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 (e.g. amputation of one leg, allergy to contrast media)
Резюме исследования
Enrollment Goal
Trial Dates
Phase
Могу ли я получить плацебо?
Products
Accepts Healthy Volunteers
Где принять участие
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Местоположения Kreiskrankenhaus Rheinfelden Rheinfelden, Germany, 79618 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Местоположения Krankenhaus der Barmherzigen Schwestern Linz Linz, Austria, 4010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Местоположения Szeged University Medical School Szeged, Hungary, 6725 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Местоположения University of Semmelweis Budapest, Hungary, 1089 | Contact Us: E-mail: [email protected] Phone: Not Available |
Местоположения MoH Goztepe Trainning Hospital Istanbul, Turkey, 34722 | Contact Us: E-mail: [email protected] Phone: Not Available |
Местоположения Marmara University Medical Faculty Istanbul, Turkey, 34662 | Contact Us: E-mail: [email protected] Phone: Not Available |
Местоположения Cukurova Universitesi Tip Fakultesi Hastanesi Adana, Turkey, 01330 | Contact Us: E-mail: [email protected] Phone: Not Available |
Местоположения Centro de Investigación Clínica FOQUS Bogotá, Colombia | Contact Us: E-mail: [email protected] Phone: Not Available |
Местоположения Fundación Cardioinfantil Bogotá, Colombia | Contact Us: E-mail: [email protected] Phone: Not Available |
Местоположения Cosultorio Privado Dr. Toledo Bogotá, Colombia | Contact Us: E-mail: [email protected] Phone: Not Available |
Местоположения Fakultna nemocnica s poliklinikou Bratislava, Slovakia, 826 06 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Местоположения Nemocnica Kosice-Saca Kosice - Saca, Slovakia, 040 15 | Contact Us: E-mail: [email protected] Phone: Not Available |
Местоположения Vilnius University Hospital of Emergency Care Vilnius, Lithuania, LT-04130 | Contact Us: E-mail: [email protected] Phone: Not Available |
Местоположения Keski-Suomen keskussairaala Jyväskylä, Finland, 40620 | Contact Us: E-mail: [email protected] Phone: Not Available |
Проект исследования
RECORD 1 Study: 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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Composite endpoint of total VTE i.e.: Any DVT (proximal and/or distal), Non fatal PE, Death of all causesTimeframe: Treatment period : up to day 36+/-6
Secondary Outcome
- Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE- related death (major VTE)Timeframe: Treatment period : up to day 36+/-6
- Incidence of symptomatic VTE (DVT, PE)Timeframe: Treatment period : up to day 36+/-6
- Incidence of DVT (total, proximal, distal)Timeframe: Treatment period : up to day 36+/-6
- Incidence of symptomatic VTE during follow-upTimeframe: Follow-up period: following 36+/-6 days
- The composite endpoint comprising major VTE and treatment-emergent major bleedingTimeframe: For major VTE, treatment period: up to Day 36+/-6 ; for major bleeding, from first dose of double-blind study medication to up to two days after last dose of double-blind study medication
- Incidence of the composite endpoint that results from the primary endpoint by substituting VTE related death for all deathTimeframe: Treatment period : up to day 36+/-6
- Incidence of the composite endpoint that results from major VTE by substituting all cause mortality for VTE-related deathTimeframe: Treatment period : up to day 36+/-6
- Treatment-emergent major bleedingsTimeframe: From first dose of double-blind study medication to up to two days after last dose of double-blind study medication
Дополнительная информация
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