PLASMA 2 Trial: Examination of Once Daily (QD) Dosing of A-002 In Subjects With Stable Coronary Artery Disease

NCT00525954 | Completed Phase 2

• 1 other identifier: AN-CVD2222
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 13

Brief Summary

The study will be conducted at up to 25 U.S. centers 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 2 orally active doses of A-002. The duration of study drug therapy will be 8 weeks.

Conditions

Coronary Artery Disease

Keywords

Coronary; Artery; Artheroschlerosis; Phospholipase; CAD; Coronary Artery Disease (CAD)

Outcome Measures

Primary Outcomes (1)

• The primary objective of this study is to determine the effect of once daily (QD) dosing of A-002 on sPLA2 levels and activity

Secondary Outcomes (3)

• Determine the effect of QD dosing of A-002 on sPLA2 levels and activity at each time point (Weeks 2, 4, and 8)

• Compare the effect of QD dosing of A-002 on sPLA2 enzyme levels and markers of inflammation

• Determine plasma drug concentrations with QD dosing

Interventions

A-002 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

• Planned coronary artery bypass surgery (CABG)
• Acute or chronic heart failure as defined by the New York Heart Association (NYHA) classification as functional Class III or Class IV
• Hospitalization for acute coronary syndrome (ACS) if troponin \>0.1 ng/mL in the preceding 6 weeks
• Hospitalization for ST-segment elevation acute myocardial infarction (STEMI) in the preceding 12 weeks
• Subjects with chronic inflammatory disease (e.g., rheumatoid arthritis), 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)
• Subjects enrolled in another experimental (interventional) protocol within the past 30 days prior to Screening or prior experience with A-002.
• Subjects treated for cancer within the previous 5 years except for skin basal cell carcinoma or carcinoma in situ of the cervix, with measures other than a minor, complete surgical excision (e.g., chemotherapy), or radiation therapy
• Subjects who have received immunosuppressant therapy within 30 days prior to entry
• Subjects who have received anti-tumor necrosis factor (for example, infliximab) therapy within 6 months prior to entry
• The presence of severe liver disease with cirrhosis, recent active hepatitis, active chronic hepatitis, ALT or AST \>3 x upper limit of normal, biliary obstruction with hyperbilirubinemia (total bilirubin \>2 x upper limit of normal)
• Active cholecystitis, gall bladder symptoms, or potential hepato-biliary abnormalities
• The presence of moderate or severe renal impairment (CrCl \<60 mL/min or creatinine \>1.5 x upper limit of normal), nephrotic syndrome, or subjects undergoing dialysis
• Uncontrolled diabetes mellitus (known HbA1c \>11% within the last 1 month prior to screening)
• Females who are nursing, pregnant, or intend to become pregnant during the time of the study, or subjects who have a positive serum pregnancy test at Visit 1 (if the subject is a female of child-bearing potential). Women of child-bearing potential must also use a reliable method of birth control during the study and for 1 month following completion of therapy. A reliable method for this study is defined as one of the following: oral or injectable contraceptives, intrauterine device (IUD), contraceptive implants, tubal ligation, hysterectomy, a double-barrier method (diaphragm with spermicidal foam or jelly, or a condom).

Sponsors & Collaborators

• Anthera Pharmaceuticals: lead

Study Sites (13)

Mobile Heart Specialists

Mobile, Alabama, 36608, United States

Location

Sonoran Health Specialists

Scottsdale, Arizona, 85260, United States

Location

Pasco Cardiology Center

Hudson, Florida, 34667, United States

Location

Charlotte Cardiovascular Institute

Port Charlotte, Florida, 33952, United States

Location

Florida Cardiovascular Research Institute

Tampa, Florida, 33609, United States

Location

Augusta Cardiology Clinic

Augusta, Georgia, 30901, United States

Location

Louisville Cardiology Medical Group

Louisville, Kentucky, 40207, United States

Location

Maine Research Associates

Auburn, Maine, 04210, United States

Location

United Medical Associates

Binghamton, New York, 13901, United States

Location

Cardiology PC

Syracuse, New York, 13210, United States

Location

Austin Heart

Austin, Texas, 78705, United States

Location

Clinical Research Associates of Tidewater

Norfolk, Virginia, 23507, United States

Location

Wisconsin Heart, SC

Madison, Wisconsin, 53715, United States

Location

Related Publications (1)

• Rosenson RS, Elliott M, Stasiv Y, Hislop C; PLASMA II Investigators. Randomized trial of an inhibitor of secretory phospholipase A2 on atherogenic lipoprotein subclasses in statin-treated patients with coronary heart disease. Eur Heart J. 2011 Apr;32(8):999-1005. doi: 10.1093/eurheartj/ehq374. Epub 2010 Nov 16.

  PMID: 21081550 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

varespladib methyl

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 4, 2007
• First Posted: September 6, 2007
• Study Start: September 1, 2007
• Study Completion: December 1, 2007
• Last Updated: January 7, 2008

Record last verified: 2008-01

Locations

US (13)