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

Withdrawn before enrolling

Conditions studied: Pulmonary Embolism

In brief

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.

Key facts

Study ID

NCT00378027

Run by

The Cleveland Clinic

People needed

0

Starts

2006-08-01

Expected to finish

2007-04-01

Last updated by the study team

2017-01-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Cleveland Clinic 9500 Euclid Ave. — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.