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

NCT00378027 | Withdrawn FDA Drug

• 1 other identifier: 05-202
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Embolism

Keywords

Pulmonary Embolism; PE; Outpatient; Anticoagulation

Study Arms (1)

Stable Acute Pulmonary Embolism

Administer weight dosed Fondaparinux

Drug: Fondaparinux

Interventions

Fondaparinux DRUG

Administer Fondaparinux Risk Stratify

Also known as: Arixtra

Stable Acute Pulmonary Embolism

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stable acute pulmonary embolism

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Cleveland Clinic 9500 Euclid Ave.

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Buller HR, Davidson BL, Decousus H, Gallus A, Gent M, Piovella F, Prins MH, Raskob G, van den Berg-Segers AE, Cariou R, Leeuwenkamp O, Lensing AW; Matisse Investigators. Subcutaneous fondaparinux versus intravenous unfractionated heparin in the initial treatment of pulmonary embolism. N Engl J Med. 2003 Oct 30;349(18):1695-702. doi: 10.1056/NEJMoa035451.

  PMID: 14585937 BACKGROUND

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

Fondaparinux

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Oligosaccharides; Polysaccharides; Carbohydrates

Study Officials

• John R Bartholomew, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2006
• First Posted: September 19, 2006
• Study Start: August 1, 2006
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: January 27, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)