Coronary Artery Disease (CAD)Phase 2PLASMANCT00455546
PLASMA Trial: A Dose-Response Study of A-002 In Subjects With Stable Coronary Artery Disease
A Phase 2 study testing A-002 in people with Coronary Artery Disease (CAD), run by Anthera Pharmaceuticals at 36 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease (CAD)
- What is being tested?
- A-002
- How many people
- 400 participants
- Where
- 36 sitesin 2 countries
- Study dates
- Apr 2007to Sep 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 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
Trial locations and contacts
36 sites in 2 countries.
36 sites in 2 countries
United States23 sites
Lehigh Valley Hospital
Allentown, Pennsylvania, 18105
University of Michigan
Ann Arbor, Michigan, 48106
Maine Research Associates
Auburn, Maine, 04210
Augusta Cardiology Clinic, PC
Augusta, Georgia, 30901
Austin Heart
Austin, Texas, 78705
United Medical Associates
Binghamton, New York, 13901
Study site
Camp Hill, Pennsylvania
Cardiopulmonary Research Science and Technology Institute
Dallas, Texas, 75230
Henry Ford Hospital
Detroit, Michigan, 48202
Regional Clinical Research, Inc.
Endwell, New York, 13760
Broward General Medical Center
Fort Lauderdale, Florida, 33316
Central Arkansas Research
Hot Springs, Arkansas, 71913
Study site
Hudson, Florida
Louisville Cardiology Medical Group
Louisville, Kentucky, 40207
Winsconin Heart, SC
Madison, Wisconsin, 53715
Mobile Heart Specialists
Mobile, Alabama, 36608
Clinical Research Associates of Tidewater
Norfolk, Virginia, 23507
Oklahoma Cardiovascular and Hypertension Center
Oklahoma City, Oklahoma, 73132
Charlotte Cardiovascuar Research
Port Charlotte, Florida, 339521
Black Hills Clinical Research Center
Rapid City, South Dakota, 57701
Sonoran Health Specialists
Scottsdale, Arizona, 85260
Cardiology, PC
Syracuse, New York, 13210
Florida Cardiovascular Institute
Tampa, Florida, 33609
Ukraine13 sites
Dnipropetrovs'k State Medical Academy
Dnepropetrovs'k, 49027
Institute of Therapy of AMS
Kharkiv, 61039
Central Clinical Hospital "Ukrzaliznysti"
Khirkov, 61018
Strazhesko Institute of Cardiology AMS
Kviv, 03680
Strazhesko Institute of Cardiology AMS
Kyiv, 03680
Kiev Central Hospital #1
Kyiv, 01023
City Clinical Hospital No 12
Kyiv, 01103
Scientific Centre of Endocrine Surgery
Kyiv, 02175
Strazhesko Institute of Cardiology AMS
Kyiv, 03680
Institute of Gerontology AMS
Kyiv, 04114
Institute of Gerontology
Kyiv, 04114
L'viv Regional State Clinical Treatment and Diagnostics
Lviv, 79015
Hospital of "Radioprylad" Plant
Zaporizhzhya, 69108
About this study
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
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.
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-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.
- Conditions
- Coronary Artery Disease (CAD)
- Being tested
- A-002
- Keywords
- Coronary, Artery, Atherosclerosis, Phospholipase, CAD
- Medical subject headings
- Coronary Artery Disease, Atherosclerosis
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.
Comparison of active and placebo treatments with respect to change from Baseline to Week 8 in sPLA2 levels and activity.
Secondary outcomes (1)
Comparison of active and placebo treatments with respect to change in: Inflammatory markers, lipid and biochemical parameters, and LDL and HDL subclasses.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2007 (estimated)
- Study startApr 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Disease (CAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anthera Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00455546
- Sponsor's protocol ID
- AN-CVD-2221
- Acronym
- PLASMA
- Status last verified
- Jan 2008
- First submitted
- 30 Mar 2007
- Last updated
- 2 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Rosenson RS, Hislop C, McConnell D, Elliott M, Stasiv Y, Wang N, Waters DD; PLASMA Investigators. Effects of 1-H-indole-3-glyoxamide (A-002) on concentration of secretory phospholipase A2 (PLASMA study): a phase II double-blind, randomised, placebo-controlled trial. Lancet. 2009 Feb 21;373(9664):649-58. doi: 10.1016/S0140-6736(09)60403-7.
PubMed 19231633
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00455546
- Acronym / sponsor ID
- PLASMA / AN-CVD-2221
- Conditions
- Coronary Artery Disease (CAD)
- Keywords
- Coronary, Artery, Atherosclerosis, Phospholipase, CAD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Anthera PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Study completion
- Sep 2007
- First posted
- 3 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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-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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A-002 | Drug | – |
Primary outcome
Comparison of active and placebo treatments with respect to change from Baseline to Week 8 in sPLA2 levels and activity.
1 secondary outcome
Comparison of active and placebo treatments with respect to change in: Inflammatory markers, lipid and biochemical parameters, and LDL and HDL subclasses.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2010.
- Derived from this study: PubMed 19231633Rosenson RS, Hislop C, McConnell D, Elliott M, Stasiv Y, Wang N, Waters DD; PLASMA Investigators. Effects of 1-H-indole-3-glyoxamide (A-002) on concentration of secretory phospholipase A2 (PLASMA study): a phase II double-blind, randomised, placebo-controlled trial. Lancet. 2009 Feb 21;373(9664):649-58. doi: 10.1016/S0140-6736(09)60403-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
36 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing A-002 in people with Coronary Artery Disease (CAD), run by Anthera Pharmaceuticals at 36 sites in 2 countries.
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 7 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 2 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Ukraine. 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?
Comparison of active and placebo treatments with respect to change from Baseline to Week 8 in 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 NCT00455546, 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 2 Feb 2010.