ThromboembolismPhase 2NCT00375609
Factor Xa Inhibitor, PRT054021, Against Enoxaparin for the Prevention of Venous Thromboembolic Events (EXPERT)
A Phase 2 study testing Betrixaban and Enoxaparin in people with Thromboembolism, run by Portola Pharmaceuticals at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thromboembolism
- What is being tested?
- Betrixaban and Enoxaparin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 1 siteCanada
- Study dates
- May 2006to Feb 2007
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- 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").
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Thromboembolism
- Being tested
- Betrixaban, Enoxaparin
- Keywords
- Prevention of Venous Thromboembolism
- Medical subject headings
- Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BetrixabanDrug
Capsule
EnoxaparinDrug
Also called Lovenox
Administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Betrixaban 15 mg | Experimental | Betrixaban 15 mg oral twice daily for 10 to 14 days Receives: Drug: Betrixaban |
| Betrixaban 40 mg | Experimental | Betrixaban 40 mg oral twice daily for 10 to 14 days Receives: Drug: Betrixaban |
| Enoxaparin | Experimental | Enoxaparin 30 mg administered subcutaneously every 12 hours for 10 to 14 days Receives: Drug: Enoxaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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)
Incidence of adjudicated pulmonary embolism (PE) and all deep vein thrombosis (DVT) (proximal and distal) through the time of venography on Day 10 to 14 and at follow-up at approximately 6 (±2) weeks after TKR surgery
Measured: At follow-up at approximately 6 (±2) weeks after TKR surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2006 (estimated)
- Study startMay 2006
- Primary completionJan 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portola Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00375609
- Sponsor's protocol ID
- PRT05-003
- Status last verified
- Aug 2023
- First submitted
- 11 Sep 2006
- Last updated
- 7 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00375609
- Acronym / sponsor ID
- PRT05-003
- Conditions
- Thromboembolism
- Keywords
- Prevention of Venous Thromboembolism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Portola PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Jan 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 13 Sep 2006 (estimated)
- Results
- Posted 15 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Betrixaban 15 mg | Experimental | Drug: BetrixabanBetrixaban 15 mg oral twice daily for 10 to 14 days |
| Betrixaban 40 mg | Experimental | Drug: BetrixabanBetrixaban 40 mg oral twice daily for 10 to 14 days |
| Enoxaparin | Experimental | Drug: EnoxaparinEnoxaparin 30 mg administered subcutaneously every 12 hours for 10 to 14 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- • 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
Key exclusion criteria (22 listed)
- Disease Related
- 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".
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BetrixabanCapsule | Drug | Betrixaban 15 mg, Betrixaban 40 mg |
| EnoxaparinAlso: LovenoxAdministered subcutaneously | Drug | Enoxaparin |
Primary outcome
Incidence of Adjudicated Venous Thromboembolism (VTE)
Time frame: Through Day 10-14 following TKR surgery, at time of mandatory venogram
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
Incidence of Adjudicated Overt Bleeding Events: Primary Safety Endpoint
Time frame: Through follow-up at approximately 6 (±2) weeks after TKR surgery
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)
1 secondary outcome
Incidence of Adjudicated Pulmonary Embolism (PE) and All Deep Vein Thrombosis (DVT) (Proximal and Distal)
Time frame: At follow-up at approximately 6 (±2) weeks after TKR surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Betrixaban and Enoxaparin in people with Thromboembolism, run by Portola Pharmaceuticals at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adjudicated Venous Thromboembolism (VTE) (time frame: Through Day 10-14 following TKR surgery, at time of mandatory venogram). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.