Study of Alfimeprase to Rapidly Dissolve Blood Clots in the Leg and Help Prevent the Need for Surgery on Leg Arteries
Completed · 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
- NCT00115999
- Run by
- ARCA Biopharma, Inc.
- People needed
- 300
- Starts
- 2005-04-01
- Expected to finish
- 2007-02-01
- 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…
- 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
You may not qualify if…
- 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
Where it is running
- The Cleveland Clinic Foundation — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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