Acute peripheral arterial occlusion (PAO) Classification code 10062599
Conditions
Interventions
Product Name: Alfimeprase
Pharmaceutical Form: Powder and solvent for solution for injection
Pharmaceutical form of the placebo: Powder and solvent for solution for injection
Route of administration o
Sponsors
Nuvelo, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Subject (or legally acceptable representavtive) must give written informed consent -age 18 or older -acute PAO of the lower extremity with onset of symptoms within 14 days prior to randomization -acute limb ishemia classified as SVS/ISCVS Class I or IIA caused by occlusion of a native artery and/bypass graft (vein or prosthetic) -need for open vascular surgical intervention in the event of unsuccessful thrombolysis -available for follow-up assessments Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a) Contraindication to systemic anticoagulation e.g. history of documented hemorrhage requiring treatment within th past 30 days; history of hereditary bleeding disorder or knwon bleeding diathesis; major surgery or trauma, open chest massage, occular surgery or hemorrhagic retinopathy within the past 30 days; puncture at non-compressible site within 48 hours prior to administration of study drug; and history or stroke, intracranial hemorrhage, or central nervous system structural abnormalities within the past 3 months b) history of endovascular procedure or open vascular surgery on the index limb within the last 30 days c) History of significant acute or chronic kidney disease that would preclude contrast angiography d) known allergy to contrast agents e) history of heparin-induced thrombocytopenia (HIT) f) participation in any study of an investigational device, medication, biologic, or other agent within 30 days prior to randomization g) Any thombolytic therapy within 30 days prior to randomization h) past participation in any alfimeprase clinical trial i) history of hypersensitivity to aspirin j) pregnant, lactating, or actively menstruating women and women of child-bearing potential who are not using adequte contraceptive precautions (e.g. intrauterine device, oral contraceptives, barrier methods or other contraception deemed adequte by the investigator) k) uncontrolled hypertension: systolic blood pressure (BP) more than 180 mmHg or diastolic BP more than 110mm Hg at the time of baseline assessment l) hematocrit less than 30%; subjects with a low hematocrit who are not actively bleeding can be entered into this study if after transfusion their hematocrit is greater than or equal to 30% m) platelet count less than 100 x 10(9)/L on baseline labs n) investigator inability to advance guidewire through index occlusion o) medically unable to withstand an open vascular surgical procedure p) any other subject feature that in the opinion of the investigator should preclude study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of alfimeprase compared with placebo as measured by 30 day open vascular surgery free rate;Secondary Objective: To evaluate: -rate of arterial flow restoration at 4 hrs after initiation of study drug -rate of improvement in index limb-antkle-brachial index (ABI) by more than or equal to 0.15 at 30 days -change in the severity of planned surgical procedures at 30 days change in the severity of planned surgical procedures at 30 days -change in index limb pain severity score at 30 days -30 day open vascular surgery free survival rate -length of hospital stay -length of intensive care unit stay -safety;Primary end point(s): The primary efficacy outcome measure is the 30 day open vascular surgery free rate. Only open vascular surgery performed on the index limb (i.e. limb affected by this episode of acute PAO) will be counted as an event of the endpoint. | — |
Countries
Czech Republic, Germany, Hungary, Italy, Spain
Outcome results
None listed