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

Completed · Phase 2

Conditions studied: Coronary Artery Disease (CAD)

In brief

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.

Key facts

Study ID

NCT00455546

Run by

Anthera Pharmaceuticals

People needed

400

Starts

2007-04-01

Expected to finish

2007-09-01

Last updated by the study team

2010-02-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mobile Heart Specialists — Mobile, Alabama, United States
• Sonoran Health Specialists — Scottsdale, Arizona, United States
• Central Arkansas Research — Hot Springs, Arkansas, United States
• Broward General Medical Center — Fort Lauderdale, Florida, United States
• Study site — Hudson, Florida, United States
• Charlotte Cardiovascuar Research — Port Charlotte, Florida, United States
• Florida Cardiovascular Institute — Tampa, Florida, United States
• Augusta Cardiology Clinic, PC — Augusta, Georgia, United States
• Louisville Cardiology Medical Group — Louisville, Kentucky, United States
• Maine Research Associates — Auburn, Maine, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• United Medical Associates — Binghamton, New York, United States
• Regional Clinical Research, Inc. — Endwell, New York, United States
• Cardiology, PC — Syracuse, New York, United States
• Oklahoma Cardiovascular and Hypertension Center — Oklahoma City, Oklahoma, United States
• Lehigh Valley Hospital — Allentown, Pennsylvania, United States
• Study site — Camp Hill, Pennsylvania, United States
• Black Hills Clinical Research Center — Rapid City, South Dakota, United States
• Austin Heart — Austin, Texas, United States
• Cardiopulmonary Research Science and Technology Institute — Dallas, Texas, United States
• Clinical Research Associates of Tidewater — Norfolk, Virginia, United States
• Winsconin Heart, SC — Madison, Wisconsin, United States
• Strazhesko Institute of Cardiology AMS — Kyiv, 03680, Ukraine
• Dnipropetrovs'k State Medical Academy — Dnepropetrovs'k, Ukraine

Full record on ClinicalTrials.gov

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