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

Sponsor

ARCA Biopharma, Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT00338585

Collaborator

(none)

300

Enrollment

Location

Duration (Months)

27.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arterial Occlusive Diseases	Drug: alfimeprase	Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

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)

Study Start Date :

Apr 1, 2006

Actual Primary Completion Date :

Mar 1, 2007

Actual Study Completion Date :

Mar 1, 2007

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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