- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00378027
Arixtra PE Study- Outpatient Management of Stable Acute Pulmonary Embolism: Once Daily Subcutaneous Fondaparinux
January 26, 2017 updated by: The Cleveland Clinic
Phase IV, Single Arm Study to Obtain Information Regarding the Safety and Efficacy of Fondaparinux Given Outpatient for Treatment of Acute Pulmonary Embolism
To assess the safety and efficacy of outpatient treatment using fondaparinux and oral Vit K antagonist, warfarin (Coumadin) in patients with stable acute pulmonary embolus (APE)when initial therapy is administered in the hospital.
Prospectively validate risk stratification criteria for predicting patient suitability for outpatient treatment of acute pulmonary embolism.
Study Overview
Detailed Description
The current standard therapy for Acute Pulmonary Embolism (APE) involves admitting patients to the hospital for administration of parenteral anticoagulation therapy(Unfractionated Heparin, Low Molecular Weight Heparin, or Fondaparinux) as a bridge to oral Vitamin K Antagonists (warfarin{Coumadin}).
There is a group of patients who are low risk for adverse events and thus may be amenable to outpatient management.
Newly identified cardio-specific biomarkers, such as cardiac troponins (TNT and cTnI) and brain natriuretic peptide (BNP) offer added diagnostic information that has been shown to help risk stratify patients presenting with APE.
Use of the biomarkers could help separate low- from high-risk subjects, particularly the subgroup of patients who, despite hemodynamic stability at presentation, carry the highest risk of adverse events.
Once a low risk APE group is identified, a less complex and less resource-intensive but equally efficacious and safe treatment which allows earlier discharge would be desirable.
The current reference therapy is intravenous unfractionated heparin (UFH) for initial anticoagulation for a minimum of 4-5 days of overlap and until therapeutic INR is achieved.
Although low-molecular weight heparins (LMWH) have been widely used for DVT treatment, their use for patients with APE is limited to inpatient administration.
Fondaparinux sodium (Arixtra) is a synthetic and specific inhibitor of activated Factor X(Xa).
Several studies have shown that fondaparinux was more effective than enoxaparin when used as a venous thromboembolism (VTE) prophylaxis agent.
Additionally, in the published literature to date, there are no reported cases of heparin-induced thrombocytopenia (HIT) syndrome proven to be caused by fondaparinux.
Fondaparinux is approved by the Food and Drug Administration (FDA) for the treatment of acute pulmonary embolism when administered in conjunction with warfarin sodium when initial therapy is administered in the hospital.
By means of a non-randomized, open label pilot study, we seek to prospectively assess the safety and efficacy of outpatient treatment using fondaparinux and oral Vitamin K antagonists (warfarin) in patients with stable acute pulmonary embolus and validate risk stratification criteria for predicting patient suitability for outpatient therapy of acute pulmonary embolism.
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic 9500 Euclid Ave.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Stable acute pulmonary embolism
Description
Inclusion Criteria:
Patients enrolled into the trial must meet all of the following criteria:
- At least 18 years of age and able to provide informed consent
- Objectively confirmed symptomatic APE [intraluminal filling defect on spiral computed tomography (CT) or pulmonary angiography, or high- probability ventilation-perfusion (V/Q)lung scan
Stable and low risk defined as:
- Hemodynamically stable (HR≤120, no hypotension, no tachypnea, no mental status change, no shock state)
- O2 supplement ≤4 L/NC
- Lack of electrocardiographic or echocardiographic evidence for new RV strain
- Radiographically non-massive PE (absence of saddle emboli on PA gram or spiral CT, perfusion defect on V/Q scan <50%
- No significant cardiac abnormalities (EF<35%, unstable angina, positive stress test within the past 3 months without revascularization) or pulmonary disease (severe COPD, pulmonary HTN).
- Negative cardio-specific biomarkers obtained at baseline (TNT, BNP)
- No moderate or severe RV dysfunction on echocardiogram
- Women of childbearing potential must have a negative pregnancy test (urine or serum) within 24 hours of enrollment
Exclusion Criteria:
Patients meeting one or more of the following criteria are not eligible for enrollment into the trial:
- In the opinion of the clinician, the patient should receive in-patient standard medical therapy
- Contraindication for anticoagulation therapy (active or recent bleeding, recent surgery, bleeding diathesis, recent neurologic event)
- Is receiving therapeutic doses of UFH or LMWH for >24 hours
- Thrombolytic or glycoprotein IIb/IIIa agents administered within 24 hours prior to enrollment
- Platelet count <100,000
- Creatinine clearance <30 mL/min at time of enrollment
- Presence of neuraxial anesthesia and/or post-operative indwelling epidural catheter
- Known history of antiphospholipid antibody syndrome
- Weight >150 kg (330.7 lbs) or <45 kg (99.2 lbs)
- Life expectancy ≤3 months
- Associated arterial thrombosis
- Heparin induced thrombocytopenia (HIT) diagnosed within the past 100 days
- IVC filter
- Any condition that in the opinion of the investigator will prohibit compliance with study procedures and treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Stable Acute Pulmonary Embolism
Administer weight dosed Fondaparinux
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Administer Fondaparinux Risk Stratify
Other Names:
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: John R Bartholomew, MD, The Cleveland Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2006
Primary Completion (Actual)
April 1, 2007
Study Completion (Actual)
April 1, 2007
Study Registration Dates
First Submitted
September 18, 2006
First Submitted That Met QC Criteria
September 18, 2006
First Posted (Estimate)
September 19, 2006
Study Record Updates
Last Update Posted (Estimate)
January 27, 2017
Last Update Submitted That Met QC Criteria
January 26, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Embolism and Thrombosis
- Embolism
- Pulmonary Embolism
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Protease Inhibitors
- Factor Xa Inhibitors
- Antithrombins
- Serine Proteinase Inhibitors
- Anticoagulants
- Fondaparinux
- PENTA
Other Study ID Numbers
- 05-202
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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