PLASMA Trial: A Dose-Response Study of A-002 In Subjects With Stable Coronary Artery Disease

Coronary Artery Disease (CAD) Clinical Trial

— PLASMA  

Official title:

PLASMA Trial: Phospholipase Levels And Serological Markers of Atherosclerosis: A Dose-Response Clinical Pharmacology Study of A-002 In Subjects With Stable Coronary Artery Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00455546
• Other study ID #: AN-CVD-2221
• Status: Completed
• Phase: Phase 2
• First received: March 30, 2007
• Last updated: February 1, 2010
• Start date: April 2007
• Est. completion date: September 2007

Study information

• Verified date: January 2008
• Source: Anthera Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The study will be conducted at up to 80 centers worldwide and will be a double-blind randomized parallel group placebo controlled study among subjects with stable coronary artery disease (CAD). Subjects will be randomized to receive either placebo tablets or one of 4 orally active doses of A-002. The duration of study drug therapy will be 8 weeks.

Description:

A-002 represents a novel therapy for the treatment of atherosclerosis and coronary artery disease (CAD). Through the inhibition of activity A-002 may provide multifunctional activity directed against key facets of the disease process, namely a) inflammation, b) atherogenic lipid profiles and c) the atherosclerotic process. Non-clinical and clinical data from recent studies have demonstrated the benefit of early and aggressive anti-inflammatory therapy to reduce cardiovascular risk. Recent clinical studies have provided a strong association between levels and cardiovascular event risk. The proposed Phase 2 clinical pharmacology study (Study No. AN-CVD-2221) will examine the effects of 4 different doses of A-002 compared with placebo, on enzyme levels and activity after 8 weeks of treatment. In addition, the effect of treatment on inflammatory markers of cardiovascular risk (C-reactive protein [CRP]), lipid levels and lipoprotein subclasses and other soluble biomarkers (e.g., ICAM-1, VCAM-1, TNF, MCP-1 etc) will also be assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Subjects are eligible for inclusion if they meet the following inclusion criteria:

• Men and women > 18 years of age

• Written informed consent from the subject

• Stable CAD

• Stable medical condition, will be compliant and able to comply with the requirements of the protocol

Exclusion Criteria:

• Subjects must NOT meet any of the following exclusion criteria:

• Planned CABG

• Hospitalization for acute coronary syndrome if troponin level is >0.1 ng/mL in the preceding 6 weeks

• Hospitalization for ST-segment acute myocardial infarction (STEMI) in the preceding 12 weeks

• Subjects with chronic inflammatory disease (e.g., RA), inflammatory bowel disease, recent (12 weeks) systemic or localized infection (the latter requiring clinical intervention), or major surgery

• hs-CRP >15 mg/L repeated on at least 2 occasions >24 hours apart due to non-cardiovascular systemic inflammatory conditions (e.g., rheumatoid disease)

• Acute or chronic heart failure as defined by the NYHA classification as functional Class III or Class IV

Study Design

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Disease (CAD)
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• A-002

Locations

Country	Name	City	State
Ukraine	Dnipropetrovs'k State Medical Academy	Dnepropetrovs'k
Ukraine	Institute of Therapy of AMS	Kharkiv
Ukraine	Central Clinical Hospital "Ukrzaliznysti"	Khirkov
Ukraine	Strazhesko Institute of Cardiology AMS	Kviv
Ukraine	City Clinical Hospital No 12	Kyiv
Ukraine	Institute of Gerontology	Kyiv
Ukraine	Institute of Gerontology AMS	Kyiv
Ukraine	Kiev Central Hospital #1	Kyiv
Ukraine	Scientific Centre of Endocrine Surgery	Kyiv
Ukraine	Strazhesko Institute of Cardiology AMS	Kyiv
Ukraine	Strazhesko Institute of Cardiology AMS	Kyiv	03680
Ukraine	L'viv Regional State Clinical Treatment and Diagnostics	L'viv
Ukraine	Hospital of "Radioprylad" Plant	Zaporizhzhya
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	University of Michigan	Ann Arbor	Michigan
United States	Maine Research Associates	Auburn	Maine
United States	Augusta Cardiology Clinic, PC	Augusta	Georgia
United States	Austin Heart	Austin	Texas
United States	United Medical Associates	Binghamton	New York
United States	Cardiopulmonary Research Science and Technology Institute	Dallas	Texas
United States	Henry Ford Hospital	Detroit	Michigan
United States	Regional Clinical Research, Inc.	Endwell	New York
United States	Broward General Medical Center	Ft. Lauderdale	Florida
United States	Central Arkansas Research	Hot Springs	Arkansas
United States	Louisville Cardiology Medical Group	Louisville	Kentucky
United States	Winsconin Heart, SC	Madison	Wisconsin
United States	Mobile Heart Specialists	Mobile	Alabama
United States	Clinical Research Associates of Tidewater	Norfolk	Virginia
United States	Oklahoma Cardiovascular and Hypertension Center	Oklahoma City	Oklahoma
United States	Charlotte Cardiovascuar Research	Port Charlotte	Florida
United States	Black Hills Clinical Research Center	Rapid City	South Dakota
United States	Sonoran Health Specialists	Scottsdale	Arizona
United States	Cardiology, PC	Syracuse	New York
United States	Florida Cardiovascular Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Anthera Pharmaceuticals

Countries where clinical trial is conducted

United States,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of active and placebo treatments with respect to change from Baseline to Week 8 in sPLA2 levels and activity.
Secondary	Comparison of active and placebo treatments with respect to change in: Inflammatory markers, lipid and biochemical parameters, and LDL and HDL subclasses.