Status:
WITHDRAWN
Arixtra PE Study- Outpatient Management of Stable Acute Pulmonary Embolism: Once Daily Subcutaneous Fondaparinux
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Pulmonary Embolism
Eligibility:
All Genders
18+ years
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...
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 Molecul...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00378027
Start Date
August 1 2006
End Date
April 1 2007
Last Update
January 27 2017
Active Locations (1)
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1
Cleveland Clinic 9500 Euclid Ave.
Cleveland, Ohio, United States, 44195