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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

June 15, 2006
January 8, 2008
April 2006
March 2007   (final data collection date for primary outcome measure)
Not Provided
30-day open vascular surgery free rate
Complete list of historical versions of study NCT00338585 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Study of Alfimeprase's Ability to Dissolve Blood Clots in the Leg and Help Prevent the Need for Surgery
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)

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Arterial Occlusive Diseases
Drug: alfimeprase
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
300
March 2007
March 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00338585
HA007, NAPA-3
Yes
Brian Kersten, PhD, Nuvelo, Inc.
ARCA Biopharma, Inc.
Not Provided
Study Director: Mohammad Hirmand, MD ARCA Biopharma, Inc.
ARCA Biopharma, Inc.
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP