Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00378027
Status:
WITHDRAWN
Last Update Posted:
2017-01-27
First Post:
2006-09-18
Brief Title:
Arixtra PE Study- Outpatient Management of Stable Acute Pulmonary Embolism Once Daily Subcutaneous Fondaparinux
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
enrollment criteria not met by PI patient population
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 APEwhen initial therapy is administered in the hospital Prospectively validate risk stratification criteria for predicting patient suitability for outpatient treatment of acute pulmonary embolism
Detailed Description:
The current standard therapy for Acute Pulmonary Embolism APE involves admitting patients to the hospital for administration of parenteral anticoagulation therapyUnfractionated Heparin Low Molecular Weight Heparin or Fondaparinux as a bridge to oral Vitamin K Antagonists warfarinCoumadin 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 XXa 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None