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Clinical Trials/EUCTR2006-006896-19-FR
EUCTR2006-006896-19-FRActive, not recruitingPhase 1

A Phase 3, Randomized, Double-blind, Active-controlled (Enoxaparin 40 mg QD),Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Apixabanin Subjects Undergoing Elective Total Knee Replacement Surgery.+ Revised Protocol 01: Incorporates Amendment 02 dated 18-Apr-2007 - The ADVANCE - 2 Study

Bristol Myers Squibb International Corporation0 sites3,670 target enrollmentStarted: June 15, 2007Last updated:
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Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
3,670
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1) Subjects must be willing and able to give written informed consent. Consent to
  • •participate in the study must be obtained prior to any screening procedures.
  • •2) Subjects undergoing elective unilateral or bilateral same day total knee replacement or a revision of at least one component of a total knee replacement.
  • •3) Subject must be willing and able to undergo bilateral ascending contrast
  • •venography.
  • •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. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 48 hours prior to the start of investigational product.
  • •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

  • •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
  • •4) Known or suspected or acquired 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
  • •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
  • •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 Section 6.3.4)
  • •16) ALT or AST > 2 x ULN or a Total Bilirubin = 1.5 x ULN (unless an alternative
  • •causative factor [eg, Gilbert’s syndrome] is identified)
  • •17) Hypersensitivity to unfractionated heparin (UFH), low molecular weight heparin
  • •(LMWH), porcine products, or iodinated contrast medium (for venogram)
  • •18) Need for ongoing treatment with a parenteral or oral anticoagulant (eg, 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
  • •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.

Investigators

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