Alfimeprase for Thrombolysis in Acute Peripheral Arterial Occlusion

This study has been completed.

First Received on November 24, 2003. Last Updated on December 16, 2009 History of Changes

Sponsor:	ARCA Biopharma, Inc.
Collaborator:	Health Decisions
Information provided by:	ARCA Biopharma, Inc.
ClinicalTrials.gov Identifier:	NCT00073554

Purpose

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	Intervention	Phase
Arterial Occlusive Diseases Peripheral Vascular Diseases Thrombosis	Drug: Alfimeprase	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Peripheral Arterial Disease Vascular Diseases

Drug Information available for: Alfimeprase

U.S. FDA Resources

Further study details as provided by ARCA Biopharma, Inc.:

Estimated Enrollment:	100
Study Start Date:	June 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00073554

Locations

United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States

Sponsors and Collaborators

ARCA Biopharma, Inc.

Health Decisions

More Information

Additional Information:

Alfimeprase Information This link exits the ClinicalTrials.gov site

Publications:

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

ClinicalTrials.gov Identifier:	NCT00073554 History of Changes
Other Study ID Numbers:	HA002, NAPA-1
Study First Received:	November 24, 2003
Last Updated:	December 16, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Thrombosis
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease

Cardiovascular Diseases
Embolism and Thrombosis
Atherosclerosis
Arteriosclerosis

ClinicalTrials.gov processed this record on February 12, 2012