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Coronary Artery DiseasePhase 2PLASMA 2NCT00525954

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

A Phase 2 study testing A-002 in people with Coronary Artery Disease, run by Anthera Pharmaceuticals at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
A-002
How many people
120 participants
Where
13 sitesUnited States
Study dates
Sep 2007to Dec 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Subjects must NOT meet any of the following exclusion criteria:
  • 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
Show all 21Show fewer
  • 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).
  • Subjects who have a history of alcohol or drug abuse within 1 year of study entry
  • Subject living too far from participating center or unable to return for follow-up visits
  • Subjects who in the opinion of the Investigator are a poor medical or psychiatric risk for therapy with an investigational drug, are unreliable, or have an incomplete understanding of the study which may affect their ability to take drugs as prescribed or comply with instructions
  • Known human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C Virus (HCV) infection
  • Treatment with any systemic corticosteroid within the 30-day period prior to study entry or the use of inhaled steroids within the 14-day period prior to study entry

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • Maine Research Associates

    Auburn, Maine, 04210

  • Augusta Cardiology Clinic

    Augusta, Georgia, 30901

  • Austin Heart

    Austin, Texas, 78705

  • United Medical Associates

    Binghamton, New York, 13901

  • Pasco Cardiology Center

    Hudson, Florida, 34667

  • Louisville Cardiology Medical Group

    Louisville, Kentucky, 40207

  • Wisconsin Heart, SC

    Madison, Wisconsin, 53715

  • Mobile Heart Specialists

    Mobile, Alabama, 36608

  • Clinical Research Associates of Tidewater

    Norfolk, Virginia, 23507

  • Charlotte Cardiovascular Institute

    Port Charlotte, Florida, 33952

  • Sonoran Health Specialists

    Scottsdale, Arizona, 85260

  • Cardiology PC

    Syracuse, New York, 13210

  • Florida Cardiovascular Research Institute

    Tampa, Florida, 33609

Other trials in United States

About this study

Official title: Phospholipase Levels And Serological Markers of Atherosclerosis 2: An Examination of Once Daily (QD) Dosing of A-002 In Subjects With Stable Coronary Artery Disease

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.

Read the detailed 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-2222) will examine the effects of 2 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.

Being tested
A-002
Keywords
Coronary, Artery, Artheroschlerosis, Phospholipase, CAD, Coronary Artery Disease (CAD)
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • A-002Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

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

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

  3. Determine plasma drug concentrations with QD dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2007 (estimated)
  2. Study startSep 2007
  3. Study completionDec 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00525954
Sponsor's protocol ID
AN-CVD2222
Acronym
PLASMA 2
Status last verified
Jan 2008
First submitted
4 Sep 2007
Last updated
7 Jan 2008
Results posted
No

Publications

  • 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.

    PubMed 21081550

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing A-002 in people with Coronary Artery Disease, run by Anthera Pharmaceuticals at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary objective of this study is to determine the effect of once daily (QD) dosing of A-002 on sPLA2 levels and activity. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00525954, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2008.

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