Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been terminated.
(Based upon preliminary safety and efficacy results from a similar study.)
Information provided by:
ARCA Biopharma, Inc. Identifier:
First received: June 15, 2006
Last updated: January 8, 2008
Last verified: January 2008
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 Intervention Phase
Arterial Occlusive Diseases
Drug: alfimeprase
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Phase 3, Multicenter, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Alfimeprase in Subjects With Acute Peripheral Arterial Occlusion (NAPA-3)

Further study details as provided by ARCA Biopharma, Inc.:

Secondary Outcome Measures:
  • rate of arterial flow restoration
  • rate of improvement in index limb ABI
  • change in WIQ functional status scores
  • AEs and SAEs
  • major bleeding events
  • ICH
  • peripheral arterial embolic events
  • all cause mortality
  • surgical and endovascular procedures
  • amputation
  • changes in chemistry, hematology, and coagulation parameters based on central laboratory measurements
  • anti-alfimeprase antibody

Estimated Enrollment: 300
Study Start Date: April 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
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.

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00338585

United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
ARCA Biopharma, Inc.
Study Director: Mohammad Hirmand, MD ARCA Biopharma, Inc.
  More Information

Responsible Party: Brian Kersten, PhD, Nuvelo, Inc. Identifier: NCT00338585     History of Changes
Other Study ID Numbers: HA007
Study First Received: June 15, 2006
Last Updated: January 8, 2008

Keywords provided by ARCA Biopharma, Inc.:
acute peripheral arterial occlusion
blood clot
leg attack
plasminogen activator
arterial flow

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases processed this record on April 21, 2017