Study Effect of VIA-2291 on Atherosclerotic Vascular Inflammation in Patients Undergoing Elective Carotid Endarterectomy - Full Text View

Purpose

This is a Phase II, randomized, double-blind, placebo-controlled study of the effect of VIA-2291 on atherosclerotic vascular inflammation in patients with carotid stenosis scheduled for elective carotid endarterectomy

Condition	Intervention	Phase
Atherosclerosis	Drug: VIA-2291 Drug: Placebo	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	VIA-2291-02, A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Effects of VIA-2291 on Atherosclerotic Plaque and Vascular Inflammation in Patients With Carotid Stenosis Undergoing Elective Carotid Endarterectomy

Further study details as provided by VIA Pharmaceuticals:

Primary Outcome Measures:

Changes in Biomarkers of Vascular Inflammation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	50
Study Start Date:	July 2006
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental VIA-2291	Drug: VIA-2291 100 mg, oral dosing, 1 time daily for 12 weeks
2: Placebo Comparator Matching Placebo	Drug: Placebo oral dosing, 1 time daily for 12 weeks

Detailed Description:

This is a study to compare the effect of VIA-2291 vs. Placebo on various inflammatory biomarkers in patients scheduled for elective carotid endarterectomy

Eligibility

Ages Eligible for Study:	30 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Female patients must be of non-childbearing potential
Carotid stenosis between 60% and 90% and to be scheduled for CEA surgery
One or more of the following clinical features: Prior history >4 weeks of cerebrovascular accident (CVA) or transient ischemic attack (TIA) consistent with North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria or prior history of amaurosis fugax occurring at any time
Diabetes haemoglobin (Hb) A1c between 7.0 and 11% or a history of two or more fasting blood glucose levels >6.9 mmol/L
Baseline hsCRP >2 mg/L
Echolucent plaque

Exclusion Criteria:

Acute CVA or TIA within 4 weeks of enrollment or the presence of ulcerated or unstable plaque requiring urgent carotid endarterectomy
Renal insufficiency defined as creatinine >1.5 x upper limit of normal (ULN)
Cirrhosis, recent hepatitis, alanine aminotransferase (ALT) >1 x ULN (i.e., above the normal range) or positive screening test for hepatitis B (hepatitis B surface antigen) or hepatitis C (by ELISA)
Uncontrolled diabetes mellitus within 1 month prior to study screening, defined as HbA1c >11% at screening
Congestive heart failure (CHF) defined by the New York Heart Association as functional Class III or IV
Recent acute coronary syndrome event or coronary artery bypass graft (CABG) surgery (within 4 weeks of enrollment)
Current atrial fibrillation
Planned cardiac intervention
Acetaminophen use in any form in the 7 days before enrollment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00352417

Locations


United States, California
	VIA Pharmaceuticals, Inc
	San Francisco, California, United States, 94111

United States, New Jersey
	VIA Pharmaceuticals, Inc.
	Princeton, New Jersey, United States, 08540

Sponsors and Collaborators

VIA Pharmaceuticals

Investigators


Study Director:	Rebecca Taub, MD	VIA Pharmaceuticals

More Information

Responsible Party:	VIA Pharmaceuticals, Inc. ( Rebecca Taub, MD; Sr. Vice President, Research and Development )
Study ID Numbers:	VIA-2291-02, EudraCT No. 2006-001635-21
First Received:	July 12, 2006
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00352417
Health Authority:	Italy: Ethics Committee

Study placed in the following topic categories:

Arterial Occlusive Diseases

Atherosclerosis

Carotid Stenosis

Vascular Diseases

Constriction, Pathologic

Arteriosclerosis

Inflammation

Additional relevant MeSH terms:

Pathologic Processes

Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 03, 2008

Sponsored by:	VIA Pharmaceuticals
Information provided by:	VIA Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00352417