NCT00115999

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

January 15, 2008

Status Verified

January 1, 2008

Enrollment Period

1.8 years

First QC Date

June 26, 2005

Last Update Submit

January 8, 2008

Conditions

Arterial Occlusive Diseases

Keywords

PAOacute peripheral arterial occlusionthrombolysisblood clotleg attackalfimeprasethrombusembolismthromboembolismclaudicationthrombolyticthrombosisplasminogen activatorarterial flow

Outcome Measures

Primary Outcomes (1)

  • 30 day open vascular surgery free rate

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Interventions

alfimepraseDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Location

Related Links

MeSH Terms

Conditions

Arterial Occlusive DiseasesThrombosisEmbolismThromboembolismIntermittent Claudication

Interventions

alfimeprase

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesEmbolism and ThrombosisPeripheral Arterial DiseasePeripheral Vascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Steven R Deitcher, MD

    ARCA Biopharma, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 26, 2005

First Posted

June 27, 2005

Study Start

April 1, 2005

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

January 15, 2008

Record last verified: 2008-01

Locations

US(1)