Alfimeprase for Thrombolysis in Acute Peripheral Arterial Occlusion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Arterial Occlusive Diseases Peripheral Vascular Diseases Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Alfimeprase

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Countries

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United States

References

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

Reference Type BACKGROUND

PMID: 11910179 (View on PubMed)

Other Identifiers

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NAPA-1

Identifier Type: -

Identifier Source: secondary_id

HA002