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

NCT00375609 | Completed Phase 2 Results

• 1 other identifier: PRT05-003
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thromboembolism

Keywords

Prevention of Venous Thromboembolism

Outcome Measures

Primary Outcomes (2)

• Incidence of Adjudicated Venous Thromboembolism (VTE)

  Incidence of adjudicated venous thromboembolism (VTE) through Day 10-14 following TKR where VTE is defined as DVT (proximal and/or distal) and/or PE. Patients were evaluated for VTE daily while hospitalized and were contacted every 2 to 4 days after discharge and before the day of the mandatory venogram to monitor for study endpoints

  Through Day 10-14 following TKR surgery, at time of mandatory venogram

• Incidence of Adjudicated Overt Bleeding Events: Primary Safety Endpoint

  The incidence of adjudicated major and clinical relevant non-major bleeding. Major bleeding was defined as fatal, involving vital organs, requiring additional surgery or a new therapeutic procedure, or a bleeding index \>=2. Bleeding Index was defined as the number of units of packed red blood cells or whole blood transfused plus the haemoglobin values before the bleeding episode minus the haemoglobin values after the bleed had stabilized (in g/dL)

  Through follow-up at approximately 6 (±2) weeks after TKR surgery

Secondary Outcomes (1)

• Incidence of Adjudicated Pulmonary Embolism (PE) and All Deep Vein Thrombosis (DVT) (Proximal and Distal)

  At follow-up at approximately 6 (±2) weeks after TKR surgery

Study Arms (3)

Betrixaban 15 mg

EXPERIMENTAL

Betrixaban 15 mg oral twice daily for 10 to 14 days

Drug: Betrixaban

Betrixaban 40 mg

EXPERIMENTAL

Betrixaban 40 mg oral twice daily for 10 to 14 days

Drug: Betrixaban

Enoxaparin

EXPERIMENTAL

Enoxaparin 30 mg administered subcutaneously every 12 hours for 10 to 14 days

Drug: Enoxaparin

Interventions

Betrixaban DRUG

Capsule

Betrixaban 15 mg; Betrixaban 40 mg

Enoxaparin DRUG

Administered subcutaneously

Also known as: Lovenox

Enoxaparin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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".

Sponsors & Collaborators

• Portola Pharmaceuticals: lead

Study Sites (1)

Montreal General Hospital

Montreal, Quebec, H3Y 3B8, Canada

Location

MeSH Terms

Conditions

Thromboembolism

Interventions

betrixaban; Enoxaparin

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Head of Clinical Development
• Organization: Portola Pharmaceuticals, Inc.

650-246-7000

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2006
• First Posted: September 13, 2006
• Study Start: May 1, 2006
• Primary Completion: January 1, 2007
• Study Completion: February 1, 2007
• Last Updated: August 7, 2023
• Results First Posted: December 15, 2017

Record last verified: 2023-08

Locations

CA (1)