Study of Alfimeprase's Ability to Dissolve Blood Clots in the Leg and Help Prevent the Need for Surgery

Stopped early · Phase 3

Conditions studied: Arterial Occlusive Diseases

In brief

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 vascular free surgery rate.

Key facts

Study ID

NCT00338585

Run by

ARCA Biopharma, Inc.

People needed

300

Starts

2006-04-01

Expected to finish

2007-03-01

Last updated by the study team

2008-01-15

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Montefiore Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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