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TerminatedNCT00338585Updated Jan 15, 2008

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

A Phase 3 interventional study of alfimeprase in Arterial Occlusive Diseases, sponsored by ARCA Biopharma, Inc.. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-01-15.

Sponsored by ARCA Biopharma, Inc. · Phase 3, Interventional, and Treatment

Why this study was terminated
Based upon preliminary safety and efficacy results from a similar study.
Phase
Phase 3
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Arterial Occlusive Diseases

Keywords

  • PAO
  • acute peripheral arterial occlusion
  • thrombolysis
  • blood clot
  • leg attack
  • alfimeprase
  • thrombus
  • embolism
  • thromboembolism
  • claudication
  • thrombolytic
  • thrombosis
  • plasminogen activator
  • arterial flow
03

In context

Arterial Occlusive Diseases

297 studies on the registry are indexed under Arterial Occlusive Diseases; 44 are open to participants now.

This study's enrollment of 300 is above the median of 121 across 200 interventional studies indexed under Arterial Occlusive Diseases.

Browse Arterial Occlusive Diseases studies →

Lead sponsor

ARCA Biopharma, Inc. is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
300 participants

Interventions

06

What researchers measure

Secondary outcomes

  1. rate of arterial flow restoration

  2. rate of improvement in index limb ABI

  3. change in WIQ functional status scores

  4. AEs and SAEs

  5. major bleeding events

  6. ICH

  7. peripheral arterial embolic events

  8. all cause mortality

  9. surgical and endovascular procedures

  10. amputation

  11. changes in chemistry, hematology, and coagulation parameters based on central laboratory measurements

  12. anti-alfimeprase antibody

07

Study locations

1 site
  • Montefiore Medical Center
    The Bronx, New York 10467, United States
08

References and documents

Related links

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2006, a primary completion of Mar 2007 and a completion of Mar 2007. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 15, 2006
First posted
Jun 20, 2006
Start
Apr 2006
Primary completionActual
Mar 2007
CompletionActual
Mar 2007
Last update
Jan 15, 2008
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 15, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00338585
Lead sponsor
ARCA Biopharma, Inc.
First posted
Jun 20, 2006
Start date
Apr 2006
Primary completion
Mar 2007
Completion
Mar 2007
Last update
Jan 15, 2008

Study contacts

Mohammad Hirmand, MD
study director · ARCA Biopharma, Inc.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.

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Discussion

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