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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.)
Sponsor:
Information provided by:
ARCA Biopharma, Inc.
ClinicalTrials.gov Identifier:
NCT00338585
First received: June 15, 2006
Last updated: January 8, 2008
Last verified: January 2008
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00338585

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

Additional Information:
Company Website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Brian Kersten, PhD, Nuvelo, Inc.
ClinicalTrials.gov Identifier: NCT00338585     History of Changes
Other Study ID Numbers: HA007, NAPA-3
Study First Received: June 15, 2006
Last Updated: January 8, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by ARCA Biopharma, Inc.:
PAO
acute peripheral arterial occlusion
thrombolysis
blood clot
leg attack
alfimeprase
thrombus
 embolism
thromboembolism
claudication
thrombolytic
thrombosis
plasminogen activator
arterial flow

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013