Status:
TERMINATED
Study of Alfimeprase's Ability to Dissolve Blood Clots in the Leg and Help Prevent the Need for Surgery
Lead Sponsor:
ARCA Biopharma, Inc.
Conditions:
Arterial Occlusive Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to directly compare the safety and efficacy of intra-thrombus alfimeprase 0.3 mg/kg with placebo in acute peripheral arterial occlusion (PAO) as measured by a 30 day open ...
Detailed Description
There is an unmet medical need to improve thrombolytic therapy in acute peripheral arterial occlusion (PAO). Currently used plasminogen activators can result in increased circulating levels of plasmin...
Eligibility Criteria
Inclusion
- Age 18 or older
- Arteriographically confirmed acute PAO of the lower extremity with onset of symptoms within 14 days prior to randomization
- Acute index limb ischemia classified as SVS/ISCVS Class I or IIa caused by occlusion of a native artery and/or bypass graft (vein or prosthetic). Only Class I subjects with abrupt onset of ischemic rest pain or abrupt onset/progression of lifestyle-limiting claudication are eligible
- Acute PAO with a need for urgent surgical intervention to restore arterial blood flow in the event of unsuccessful thrombolytic therapy
- Available for follow-up assessments
Exclusion
- Contraindication to systemic anticoagulation
- History of endovascular procedure or open vascular surgery on the index limb within the past 30 days
- History of significant acute or chronic kidney disease that would preclude contrast angiography
- Known allergy to contrast agents
- History of heparin induced thrombocytopenia
- Participation in any study of an investigational device, medication, biologic, or other agent within 30 days prior to randomization
- Any thrombolytic therapy within 5 days prior to randomization
- Past participation in any alfimeprase trial
- Pregnant, lactating, or actively menstruating women or women of childbearing potential who are not using adequate contraceptive precautions
- Investigator inability to advance guidewire through index occlusion
- Any other subject feature that in the opinion of the investigator should preclude study participation
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00338585
Start Date
April 1 2006
End Date
March 1 2007
Last Update
January 15 2008
Active Locations (1)
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1
Montefiore Medical Center
The Bronx, New York, United States, 10467