Study of Alfimeprase's Ability to Dissolve Blood Clots in the Leg and Help Prevent the Need for Surgery

NCT00338585 | Terminated Phase 3 DMC

• 2 other identifiers: HA007NAPA-3
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to directly compare the safety and efficacy of intra-thrombus alfimeprase 0.3 mg/kg with placebo in acute peripheral arterial occlusion (PAO) as measured by a 30 day open vascular free surgery rate.

Conditions

Arterial Occlusive Diseases

Keywords

PAO; acute peripheral arterial occlusion; thrombolysis; blood clot; leg attack; alfimeprase; thrombus; embolism; thromboembolism; claudication; thrombolytic; thrombosis; plasminogen activator; arterial flow

Outcome Measures

Secondary Outcomes (12)

• rate of arterial flow restoration

• rate of improvement in index limb ABI

• change in WIQ functional status scores

• AEs and SAEs

• major bleeding events

Interventions

alfimeprase DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Arteriographically confirmed acute PAO of the lower extremity with onset of symptoms within 14 days prior to randomization
• Acute index limb ischemia classified as SVS/ISCVS Class I or IIa caused by occlusion of a native artery and/or bypass graft (vein or prosthetic). Only Class I subjects with abrupt onset of ischemic rest pain or abrupt onset/progression of lifestyle-limiting claudication are eligible
• Acute PAO with a need for urgent surgical intervention to restore arterial blood flow in the event of unsuccessful thrombolytic therapy
• Available for follow-up assessments

You may not qualify if:

• Contraindication to systemic anticoagulation
• History of endovascular procedure or open vascular surgery on the index limb within the past 30 days
• History of significant acute or chronic kidney disease that would preclude contrast angiography
• Known allergy to contrast agents
• History of heparin induced thrombocytopenia
• Participation in any study of an investigational device, medication, biologic, or other agent within 30 days prior to randomization
• Any thrombolytic therapy within 5 days prior to randomization
• Past participation in any alfimeprase trial
• Pregnant, lactating, or actively menstruating women or women of childbearing potential who are not using adequate contraceptive precautions
• Investigator inability to advance guidewire through index occlusion
• Any other subject feature that in the opinion of the investigator should preclude study participation

Sponsors & Collaborators

• ARCA Biopharma, Inc.: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Links

• Company Website

MeSH Terms

Conditions

Arterial Occlusive Diseases; Thrombosis; Embolism; Thromboembolism; Intermittent Claudication

Interventions

alfimeprase

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Peripheral Arterial Disease; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohammad Hirmand, MD

  ARCA Biopharma, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 15, 2006
• First Posted: June 20, 2006
• Study Start: April 1, 2006
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: January 15, 2008

Record last verified: 2008-01

Locations

US (1)