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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00115999
Recruitment Status : Completed
First Posted : June 27, 2005
Last Update Posted : January 15, 2008
Information provided by:
ARCA Biopharma, Inc.

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 vascular free surgery rate.

Condition or disease Intervention/treatment Phase
Arterial Occlusive Diseases Drug: alfimeprase Phase 3

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 that result in a systemic "lytic state" that does not distinguish between physiologic and pathologic thrombosis. In general, mean plasminogen activator infusion durations of greater than 24 hours in order to achieve successful thrombolysis are problematic in a disease where delayed restoration of arterial flow can lead to irreversible ischemic damage. A direct thrombolytic agent like alfimeprase, with a rapid mechanism of action and a potentially safer bleeding risk profile, could facilitate a rapid restoration of arterial flow and avoidance of open vascular surgery.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Phase 3, Multicenter, Multi-National, Randomized, Partial Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Alfimeprase in Subjects With Acute Peripheral Arterial Occlusion
Study Start Date : April 2005
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Primary Outcome Measures :
  1. 30 day open vascular surgery free rate

Secondary Outcome Measures :
  1. Rate of arterial flow restoration at 4 hours after initiation of study drug
  2. Rate of improvement in index limb ABI by >=0.15 at 30 days
  3. Change in the severity of planned surgical procedures at 30 days
  4. Change in index limb pain severity score at 30 days
  5. 30 day open vascular surgery free survival rate
  6. Length of hospital stay
  7. Length of intensive care unit (ICU) stay
  8. Safety

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00115999

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United States, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Sponsors and Collaborators
ARCA Biopharma, Inc.
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Study Director: Steven R Deitcher, MD ARCA Biopharma, Inc.

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Responsible Party: Brian Kersten, PhD, Nuvelo, Inc. Identifier: NCT00115999    
Other Study ID Numbers: HA004
First Posted: June 27, 2005    Key Record Dates
Last Update Posted: January 15, 2008
Last Verified: January 2008
Keywords provided by ARCA Biopharma, Inc.:
acute peripheral arterial occlusion
blood clot
leg attack
plasminogen activator
arterial flow
Additional relevant MeSH terms:
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Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases