Estudio multicéntrico, aleatorizado, doble ciego, con control activo y de grupos paralelos, fase III, para evaluar la eficacia y seguridad de Apixaban en pacientes sometidos a cirugía programada para la implantación de prótesis total de caderaA Phase 3, Randomized, Double-blind, Active-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Apixaban in Subjects Undergoing Elective Total Hip Replacement Surgery.Y enmienda farmacogenética en sangre 01-Específica de centro (Versión 1.0, fecha 27-Nov-2006)And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 1.0, Date 27-Nov-2006).

Phase 1

• Conditions: Pacientes sometidos a cirugía programada para la implantación de prótesis total de caderaSubjects undergoing elective total hip replacement (THR) surgery; MedDRA version: 9.1Level: LLTClassification code 10051055Term: Deep vein thrombosis; MedDRA version: 9.1Level: LLTClassification code 10037377Term: Pulmonary embolism

• Registration Number: EUCTR2006-005351-14-ES
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2009-09-05
• Study Start: 2010-03-04
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 4424

Inclusion Criteria

1) Signed written informed consent

Target population
2) Subjects undergoing elective unilateral total hip replacement or a revision of at least one component of a total hip replacement.
3) Subject must be willing and able to undergo bilateral ascending contrast venography.
Unless Investigator/radiologist can assure that a bilateral venogram can be performed, subjects exceeding 300 lbs. (136 kg) and/or BMI = 35 kg/m2 are to be excluded because of technical limitations due to body habitus.

Age and Sex
4) Men and women, of any race, at least 18 (or legal age of consent if greater) years of age
5) Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the treatment period of the study in such a manner that the risk of pregnancy is minimized.
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

Sex and Reproductive Status
1) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire treatment period of the study
2) Women who are pregnant or breastfeeding
3) Women with a positive pregnancy test on enrollment or prior to investigational product administration

Target Disease Exceptions
4) Known or suspected, acquired or bleeding or coagulation disorder in the subject or a first degree relative
5) Known or suspected history of heparin-induced thrombocytopenia
6) Known coagulopathy
7) Active bleeding or at high risk for bleeding

Medical History and Concurrent Diseases
8) Brain, spinal, ophthalmologic, or major surgery or trauma within the past 90 days
9) Active hepatobiliary disease
10) Alcohol and/or substance abuse within the past year
11) Any condition, in the opinion of the Investigator, for which surgery or administration of an anticoagulant is contraindicated

Physical and Laboratory Test Findings
12) Two consecutive blood pressure readings within 15-30 minutes with supine SBP > 180 mm Hg or supine DBP > 105 mm Hg
13) Hemoglobin < 10 g/dL
14) Platelet count < 100,000/mm3
15) Creatinine clearance < 30 mL/min as estimated by the method of Cockcroft and Gault (see protocol Section 6.3.4)
16) Active hepatobiliary disease, based on an ALT or AST > 2xULN or a Total Bilirubin = 1.5xULN (unless an alternative causative factor [e.g., Gilbert’s syndrome] is identified)

Allergies and Adverse Drug Reactions
17) Hypersensitivity to unfractionated heparin (UFH), low molecular weight heparin (LMWH), porcine products, or iodinated contrast medium (for venogram)

Prohibited Treatments and/or Therapies
18) Need for ongoing treatment with a parenteral or oral anticoagulant (e.g., subjects with mechanical valves, warfarin eligible atrial fibrillation)
19) Current use of dextrans or fibrinolytics
20) Treatment with medications affecting coagulation or platelet function unless they
can be withdrawn as follows:
• Unfractionated heparin, LMWH, warfarin (or any other VKA), glycoprotein IIb/IIIa inhibitors (e.g., abciximab, eptifibatide, tirofiban) within 4 days before surgery
• Clopidogrel, ticlopidine, dipyridamole, sulfinpyrazone within 7 days before surgery
• Non-selective NSAIDs with a T1/2 greater than 17 hours within 7 days before surgery
• Fondaparinux within 7 days before surgery
• Acetylsalicylic acid > 165 mg within 4 days before surgery
21) Planned indwelling intrathecal or epidural catheter that can not be removed at least 5 hours prior to first dose of post-operative study drug.

Other Exclusion Criteria
22) Prisoners or subjects who are compulsorily detained
23) Subjects who have been previously randomized into an apixaban clinical trial
24) Administration of any investigational drug currently or within 30 days prior to
enrollment into this study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified