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

This study has been completed.
Sponsor:
Information provided by:
ARCA Biopharma, Inc.
ClinicalTrials.gov Identifier:
NCT00115999
First received: June 26, 2005
Last updated: January 8, 2008
Last verified: January 2008
  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, Partial Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Alfimeprase in Subjects With Acute Peripheral Arterial Occlusion

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

Primary Outcome Measures:
  • 30 day open vascular surgery free rate

Secondary Outcome Measures:
  • Rate of arterial flow restoration at 4 hours after initiation of study drug
  • Rate of improvement in index limb ABI by >=0.15 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 (ICU) stay
  • Safety

Estimated Enrollment: 300
Study Start Date: April 2005
Study Completion Date: February 2007
Primary Completion Date: February 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:

  • 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
  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 ClinicalTrials.gov identifier: NCT00115999

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

Additional Information:
No publications provided

Responsible Party: Brian Kersten, PhD, Nuvelo, Inc.
ClinicalTrials.gov Identifier: NCT00115999     History of Changes
Other Study ID Numbers: HA004, NAPA-2
Study First Received: June 26, 2005
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 July 20, 2014