NCT00073554

Brief Summary

This trial is for patients with acute occlusion of one of the arteries supplying blood to the leg. The trial is designed to determine the safety and activity of a novel clot dissolving (thrombolytic) drug (alfimeprase).

Trial Health

80
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

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

June 1, 2003

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 26, 2003

Completed
Last Updated

December 17, 2009

Status Verified

November 1, 2006

First QC Date

November 24, 2003

Last Update Submit

December 16, 2009

Conditions

Arterial Occlusive DiseasesPeripheral Vascular DiseasesThrombosis

Interventions

AlfimepraseDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* Patients with acute peripheral arterial occlusion of the lower limb (onset of symptoms within 14 days) * Rutherford Class I or IIa (minimal sensory loss, no muscle weakness, audible venous flow) * Age 18 or above * Able to consent * Able to follow up

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Location

Related Publications (1)

  • Toombs CF. Alfimeprase: pharmacology of a novel fibrinolytic metalloproteinase for thrombolysis. Haemostasis. 2001 May-Dec;31(3-6):141-7. doi: 10.1159/000048057.

    PMID: 11910179BACKGROUND

MeSH Terms

Conditions

Arterial Occlusive DiseasesPeripheral Vascular DiseasesThrombosis

Interventions

alfimeprase

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesEmbolism and Thrombosis

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 24, 2003

First Posted

November 26, 2003

Study Start

June 1, 2003

Last Updated

December 17, 2009

Record last verified: 2006-11

Locations

US(1)