Study of Alfimeprase to Rapidly Dissolve Blood Clots in the Leg and Help Prevent the Need for Surgery on Leg Arteries

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

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 vascular free surgery rate.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ARCA Biopharma, Inc.

Criteria

Inclusion Criteria:

• Must give written informed consent

• Ages 18 or older

• Acute PAO of a 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)

• Need for open vascular surgical intervention in the event of unsuccessful thrombolysis

• Available for follow-up assessments

Exclusion Criteria:

• Contraindication to systemic anticoagulation

• History of endovascular procedure or open vascular surgery on the index limb within the last 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 (HIT)

• Participation in any study of an investigational device, medication, biologic, or other agent within 30 days prior to randomization

• Any thrombolytic therapy within 30 days prior to randomization

• Past participation in any alfimeprase clinical trial

• History of hypersensitivity to aspirin

• Pregnant, lactating, or actively menstruating women and women of child-bearing potential who are not using adequate contraceptive precautions (e.g. intrauterine device, oral contraceptives, barrier methods, or other contraception deemed adequate by the investigator)

• Uncontrolled hypertension: systolic blood pressure (BP) > 180 mmHg, or diastolic BP > 110 mmHg at the time of baseline assessment

• Hematocrit < 30%; subjects with a low hematocrit who are not actively bleeding can be entered into this study if after transfusion their hematocrit is >= 30%

• Platelet count <100 X 10(9)/L on baseline labs

• Investigator inability to advance guidewire through index occlusion

• Medically unable to withstand an open vascular surgical procedure

• Any other feature that, in the opinion of the investigator, should preclude study participation