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
  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
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:


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
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

Additional Information:
Publications:
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 August 21, 2014