Factor Xa Inhibitor, PRT054021, Against Enoxaparin for the Prevention of Venous Thromboembolic Events (EXPERT)

This study has been completed.
Sponsor:
Information provided by:
Portola Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00375609
First received: September 11, 2006
Last updated: September 10, 2007
Last verified: September 2007
  Purpose

Randomized study of PRT054021 40 mg and 15 mg bid vs. enoxaparin 30 mg q12h for the prophylaxis of venous thromboembolic events after unilateral knee replacement surgery.


Condition Intervention Phase
Thromboembolism
Drug: PRT054021
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of the Factor Xa Inhibitor, PRT054021, Against Enoxaparin in a Randomized Trial for the Prevention of Venous Thromboembolic Events After Unilateral Total Knee Replacement (EXPERT)

Resource links provided by NLM:


Further study details as provided by Portola Pharmaceuticals:

Primary Outcome Measures:
  • Deep venous thrombosis
  • Pulmonary embolism

Secondary Outcome Measures:
  • Bleeding events

Estimated Enrollment: 200
Study Start Date: May 2006
Study Completion Date: January 2007
Detailed Description:

Approximately 200 patients undergoing unilateral knee replacement will be entered into the study and randomized to receive either enoxaparin 30 mg sq bid, PRT054021 15 mg po bid, or PRT054021 40 mg po bid for 10 to 14 days, at which time patients will undergo venography.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • The subject has undergone elective primary unilateral TKR (not unicompartmental).

Demographic

  • The subject is between the ages of 18 and 75 years.
  • If the subject is a woman, she is without reproductive potential (postmenopausal for ≥2 years or after hysterectomy).
  • The subject weighs between 50 kg (110 lbs) and 120 kg (265 lbs). Laboratory and Procedures
  • The subject is willing and able to undergo unilateral venography. Medications
  • The subject is willing and able to self-inject enoxaparin or receive injections q12h by a caregiver.

Ethical

• The subject is able to read and give written informed consent and has signed an informed consent form approved by the Investigator's IRB/IEC.

Exclusion Criteria:

  • Disease Related

    • Major medical and/or surgical condition which may impair oral drug absorption or metabolism.
    • Immobilization for 3 or more days before surgery.
    • History (including family history) or symptoms of a congenital or acquired bleeding disorder or vascular malformation; or a history of intracranial, retroperitoneal, or intraocular bleeding within the last 6 months; or is felt to be at high risk for bleeding for other reasons.
    • Gastrointestinal bleeding within 90 days before surgery or endoscopically verified ulcer disease within 30 days before surgery.
    • Indwelling intrathecal or epidural catheter during the prophylaxis period (except for epidural catheter if removed after surgery); or unusual difficulty in administering spinal or epidural anesthesia (eg, 3 or more attempts, "traumatic taps").
    • Major surgery, ischemic stroke, or myocardial infarction within 3 months before Screening.
    • Uncontrolled hypertension defined as systolic blood pressure (SBP) > 180 mmHg or diastolic blood pressure (DBP) >105 mmHg.
    • Hypotension defined as SBP <95 mmHg.
    • Evidence at Screening of symptomatic congestive heart failure requiring treatment.
    • Chronic atrial fibrillation treated with oral anticoagulants, recurrent atrial arrhythmia(s) or a history of recurrent ventricular tachycardia.

Laboratory and Procedures

  • Evidence at Screening of:

    • platelet count <100,000/mm3
    • potassium <3.5 mEq/L
    • hemoglobin concentration <10 g/dL or hematocrit <30%
    • serum ALT or AST >2 times ULN
    • serum creatinine >2.0 mg/dL (180 µm/L)
  • Contraindication to venography, including to iodinated contrast medium
  • QTc on Screening ECG >450 msec and/or a personal or family history of "Long QT Syndrome".

Medications

  • Contraindication to anticoagulation for VTE prophylaxis, including a contraindication to receiving heparin or heparinoids.
  • Administration of the following drugs within 7 days before TKR: thrombolytic agents, anticoagulants and/or anti-platelet agents (eg, heparins, warfarin, dipyridamole, sulfinpyrazone, ticlopidine, dextran, clopidogrel). Aspirin up to 325 mg once daily and NSAIDs are allowed but discouraged.
  • Use of class III antiarrhythmics drugs (eg, dofetilide, ibutilide, amiodarone, bretylium, sotalol) within 30 days prior to TKR.

General

  • Participation in any investigational drug study 30 days prior to enrollment is prohibited. Participation in a device trial prior to enrollment is acceptable.
  • Any condition which could interfere with or for which the treatment of might interfere with the conduct of the study, or which would, in the opinion of the Investigator, unacceptably increase the risk of the subject's participation in the study. This would include, but is not limited to alcoholism, drug dependency or abuse, psychiatric disease, epilepsy or any unexplained blackouts.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00375609

Locations
Canada, Quebec
Montreal General Hospital
Montreal, Quebec, Canada, H3Y 3B8
Sponsors and Collaborators
Portola Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00375609     History of Changes
Other Study ID Numbers: PRT05-003
Study First Received: September 11, 2006
Last Updated: September 10, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Portola Pharmaceuticals:
Prevention of Venous Thromboembolism

Additional relevant MeSH terms:
Thromboembolism
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Enoxaparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 28, 2014