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

Sponsored by:	Nuvelo
Information provided by:	Nuvelo
ClinicalTrials.gov Identifier:	NCT00338585

Purpose

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	Intervention	Phase
Arterial Occlusive Diseases	Drug: alfimeprase	Phase III

Drug Information available for: Alfimeprase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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)

Further study details as provided by Nuvelo:

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

Estimated Enrollment:	300
Study Start Date:	April 2006
Study Completion Date:	March 2007
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00338585

Locations

United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467

Sponsors and Collaborators

Nuvelo

Investigators

Study Director:

Mohammad Hirmand, MD

Nuvelo

More Information

Company Website This link exits the ClinicalTrials.gov site

Responsible Party:	Nuvelo, Inc. ( Brian Kersten, PhD )
Study ID Numbers:	HA007, NAPA-3
Study First Received:	June 15, 2006
Last Updated:	January 8, 2008
ClinicalTrials.gov Identifier:	NCT00338585
Health Authority:	United States: Food and Drug Administration

Keywords provided by Nuvelo:

PAO
acute peripheral arterial occlusion
thrombolysis
blood clot
leg attack
alfimeprase
thrombus
embolism

thromboembolism
claudication
thrombolytic
thrombosis
plasminogen activator
arterial flow
acute peripheral arterial occlusion

Study placed in the following topic categories:

Arterial Occlusive Diseases
Embolism
Vascular Diseases

Plasminogen
Thromboembolism
Thrombosis

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009