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Alfimeprase for Thrombolysis in Acute Peripheral Arterial Occlusion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00073554
Recruitment Status : Completed
First Posted : November 26, 2003
Last Update Posted : December 17, 2009
Sponsor:
Collaborator:
Health Decisions
Information provided by:
ARCA Biopharma, Inc.

Study Description
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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).

Condition or disease Intervention/treatment Phase
Arterial Occlusive Diseases Peripheral Vascular Diseases Thrombosis Drug: Alfimeprase Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety and Activity of Alfimeprase in Patients With Acute Peripheral Arterial Occlusion
Study Start Date : June 2003
Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00073554


Locations
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United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Sponsors and Collaborators
ARCA Biopharma, Inc.
Health Decisions
More Information
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Publications:

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ClinicalTrials.gov Identifier: NCT00073554    
Other Study ID Numbers: HA002
NAPA-1
First Posted: November 26, 2003    Key Record Dates
Last Update Posted: December 17, 2009
Last Verified: November 2006
Additional relevant MeSH terms:
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Thrombosis
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Arterial Occlusive Diseases
 Embolism and Thrombosis
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis