Alfimeprase for Thrombolysis in Acute Peripheral Arterial Occlusion

This study has been completed.

Sponsor:

Collaborator:

Health Decisions

Information provided by:

ARCA Biopharma, Inc.

ClinicalTrials.gov Identifier:

NCT00073554

First received: November 24, 2003

Last updated: December 16, 2009

Last verified: November 2006

History of Changes

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 2


Study Type:	Interventional
Study Design:	Allocation: Randomized 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

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional relevant MeSH terms:


Thrombosis Vascular Diseases Peripheral Vascular Diseases Peripheral Arterial Disease Arterial Occlusive Diseases	Embolism and Thrombosis Cardiovascular Diseases Atherosclerosis Arteriosclerosis

ClinicalTrials.gov processed this record on June 23, 2017

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