Arixtra PE Study- Outpatient Management of Stable Acute Pulmonary Embolism: Once Daily Subcutaneous Fondaparinux

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00378027
Recruitment Status : Withdrawn (enrollment criteria not met by PI patient population)
First Posted : September 19, 2006
Last Update Posted : January 27, 2017
Information provided by (Responsible Party):
The Cleveland Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment
Pulmonary Embolism Drug: Fondaparinux

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
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase IV, Single Arm Study to Obtain Information Regarding the Safety and Efficacy of Fondaparinux Given Outpatient for Treatment of Acute Pulmonary Embolism
Actual Study Start Date : August 2006
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Stable Acute Pulmonary Embolism
Administer weight dosed Fondaparinux
Drug: Fondaparinux
Administer Fondaparinux Risk Stratify
Other Name: Arixtra

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Stable acute pulmonary embolism

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00378027

United States, Ohio
Cleveland Clinic 9500 Euclid Ave.
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Principal Investigator: John R Bartholomew, MD The Cleveland Clinic

Responsible Party: The Cleveland Clinic Identifier: NCT00378027     History of Changes
Other Study ID Numbers: 05-202
First Posted: September 19, 2006    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by The Cleveland Clinic:
Pulmonary Embolism

Additional relevant MeSH terms:
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents