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

Arterial Occlusive Diseases Clinical Trial

Official title:

Phase 3, Multicenter, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Alfimeprase in Subjects With Acute Peripheral Arterial Occlusion (NAPA-3)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00338585
• Other study ID #: HA007
• Secondary ID: NAPA-3
• Status: Terminated
• Phase: Phase 3
• First received: June 15, 2006
• Last updated: January 8, 2008
• Start date: April 2006
• Est. completion date: March 2007

Study information

• Verified date: January 2008
• Source: ARCA Biopharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

There is an unmet medical need to improve thrombolytic therapy in acute peripheral arterial occlusion (PAO). Currently used plasminogen activators can result in increased circulating levels of plasmin that result in a systemic "lytic state" that does not distinguish between physiologic and pathologic thrombosis. In general, mean plasminogen activator infusion durations of greater than 24 hours in order to achieve successful thrombolysis are problematic in a disease where delayed restoration of arterial flow can lead to irreversible ischemic damage. A direct thrombolytic agent like alfimeprase, with a rapid mechanism of action and a potentially safer bleeding risk profile, could facilitate a rapid restoration of arterial flow and avoidance of open vascular surgery.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 300
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arterial Occlusive Diseases

Intervention

Drug:
• alfimeprase

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
ARCA Biopharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Secondary	rate of arterial flow restoration
Secondary	rate of improvement in index limb ABI
Secondary	change in WIQ functional status scores
Secondary	AEs and SAEs
Secondary	major bleeding events
Secondary	ICH
Secondary	peripheral arterial embolic events
Secondary	all cause mortality
Secondary	surgical and endovascular procedures
Secondary	amputation
Secondary	changes in chemistry, hematology, and coagulation parameters based on central laboratory measurements
Secondary	anti-alfimeprase antibody