Acute Coronary SyndromePhase 2NCT00552188
Phase 2 Study in Vascular Inflammation on Patients After an Acute Coronary Syndrome Event
A Phase 2 study testing VIA-2291 in people with Acute Coronary Syndrome, run by Tallikut Pharmaceuticals, Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to determine the effect of VIA-2291 as compared to placebo on vascular inflammation following 24 weeks of dosing. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- VIA-2291
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2007to Nov 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients must be of non-childbearing potential
- Recent acute coronary syndrome [(ACS) ST elevation myocardial infarction (STEMI), non-STEMI or unstable angina) event documented by ECG, cardiac enzymes or angiogram] 1 - 3 months prior to randomization
- Carotid or ascending aorta artery plaque inflammation Target-to-Background Ratio (TBR) ≥ 1.6
- Receiving concomitant statin therapy following the qualifying ACS event for a minimum of 4 weeks, including a stable statin dose regimen for 2 weeks prior to randomization.
Who cannot join
- Renal insufficiency defined as creatinine >1.5 x upper limit of normal (ULN)
- Cirrhosis, recent hepatitis, alanine aminotransferase (ALT) >1.5 x ULN (i.e., above the normal range) or positive screening test for hepatitis B (hepatitis B surface antigen) or hepatitis C (by ELISA)
- Type I diabetes and uncontrolled Type 2 diabetes defined as hemoglobin A1c (HbA1c) > 9%
- Heart failure defined by New York Heart Association Class III or IV
- Coronary Artery Bypass Surgery (CABG) within 4 months of randomization
- Use of zileuton, montelukast, coumadin or steroids
Show all 10Show fewer
- Acetaminophen use in any form in the 7 days before enrollment at Visit 1
- Allergy to contrast agents
- Planned additional cardiac intervention (e.g., PCI, CABG) within next 6 months
- Current atrial fibrillation, atrial flutter or frequent premature ventricular contractions
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VIA Pharmaceuticals
Princeton, New Jersey, 08540
VIA Pharmaceuticals
San Francisco, California, 94111
About this study
Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Effect of VIA-2291, a 5-Lipoxygenase Inhibitor, on Vascular Inflammation in Patients After an Acute Coronary Syndrome Event
The purpose of this study is to determine the effect of VIA-2291 as compared to placebo on vascular inflammation following 24 weeks of dosing.
Read the detailed description
The effect of VIA-2291 on vascular inflammation will be assessed through 18FDG PET vascular imaging measurements and various biomarkers after 24 weeks.
- Conditions
- Acute Coronary Syndrome
- Being tested
- VIA-2291, Placebo
- Keywords
- Atherosclerosis
- Medical subject headings
- Acute Coronary Syndrome, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIA-2291Drug
100 mg, oral dosing, 1 time daily for 24 weeks
PlaceboDrug
oral dosing, 1 time daily for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| VIA-2291 | Experimental | VIA-2291 100mg Receives: Drug: VIA-2291 |
| Placebo | Placebo comparator | Matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Plaque Imaging After 24 Weeks
To evaluate the effect of VIA-2291 100 mg relative to placebo on the change from baseline in the target (plaque) to background (blood) ratio (TBR) from an index vessel (either right carotid, left carotid or ascending aorta) based on the standardized 18fluorodeoxy glucose (FDG) uptake measured with PET in patients with acute coronary syndrome and vascular inflammation after 24 weeks of daily dosing.
Measured: Baseline and 24 Weeks
Secondary outcomes (1)
Change From Baseline in Plaque Imaging After 6 Weeks
To evaluate the effect of VIA-2291 100 mg relative to placebo on the change from baseline in the TBR from an index vessel (either right carotid, left carotid or ascending aorta) based on the standardized 18FDG uptake measured with PET in patients after 6 weeks of daily dosing.
Measured: Baseline and 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2007 (estimated)
- Study startOct 2007
- Primary completionOct 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tallikut Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital, Icahn School of Medicine at Mount Sinai, University of Massachusetts, Worcester, Winthrop University Hospital, Montreal Heart Institute
- Responsible party
- Sponsor
- Investigators
- Rebecca Taub, MD, Study director, VIA Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00552188
- Sponsor's protocol ID
- VIA-2291-03
- Status last verified
- Jun 2013
- First submitted
- 31 Oct 2007
- Last updated
- 9 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Gaztanaga J, Farkouh M, Rudd JH, Brotz TM, Rosenbaum D, Mani V, Kerwin TC, Taub R, Tardif JC, Tawakol A, Fayad ZA. A phase 2 randomized, double-blind, placebo-controlled study of the effect of VIA-2291, a 5-lipoxygenase inhibitor, on vascular inflammation in patients after an acute coronary syndrome. Atherosclerosis. 2015 May;240(1):53-60. doi: 10.1016/j.atherosclerosis.2015.02.027. Epub 2015 Feb 24.
PubMed 25752438
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Effect of VIA-2291, a 5-Lipoxygenase Inhibitor, on Vascular Inflammation in Patients After an Acute Coronary Syndrome Event
- ClinicalTrials.gov ID
- NCT00552188
- Acronym / sponsor ID
- VIA-2291-03
- Conditions
- Acute Coronary Syndrome
- Keywords
- Atherosclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Tallikut Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital, Icahn School of Medicine at Mount Sinai, University of Massachusetts, Worcester, Winthrop University Hospital, Montreal Heart Institute
- Study start
- Oct 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 1 Nov 2007 (estimated)
- Results
- Posted 9 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effect of VIA-2291 as compared to placebo on vascular inflammation following 24 weeks of dosing.
Detailed description
The effect of VIA-2291 on vascular inflammation will be assessed through 18FDG PET vascular imaging measurements and various biomarkers after 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VIA-2291 | Experimental | Drug: VIA-2291VIA-2291 100mg |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female patients must be of non-childbearing potential
- Recent acute coronary syndrome [(ACS) ST elevation myocardial infarction (STEMI), non-STEMI or unstable angina) event documented by ECG, cardiac enzymes or angiogram] 1 - 3 months prior to randomization
- Carotid or ascending aorta artery plaque inflammation Target-to-Background Ratio (TBR) ≥ 1.6
- Receiving concomitant statin therapy following the qualifying ACS event for a minimum of 4 weeks, including a stable statin dose regimen for 2 weeks prior to randomization.
Key exclusion criteria (10 listed)
- Renal insufficiency defined as creatinine >1.5 x upper limit of normal (ULN)
- Cirrhosis, recent hepatitis, alanine aminotransferase (ALT) >1.5 x ULN (i.e., above the normal range) or positive screening test for hepatitis B (hepatitis B surface antigen) or hepatitis C (by ELISA)
- Type I diabetes and uncontrolled Type 2 diabetes defined as hemoglobin A1c (HbA1c) > 9%
- Heart failure defined by New York Heart Association Class III or IV
- Coronary Artery Bypass Surgery (CABG) within 4 months of randomization
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 |
|---|---|---|
| VIA-2291100 mg, oral dosing, 1 time daily for 24 weeks | Drug | VIA-2291 |
| Placebooral dosing, 1 time daily for 24 weeks | Drug | Placebo |
Primary outcome
Change From Baseline in Plaque Imaging After 24 Weeks
Time frame: Baseline and 24 Weeks
To evaluate the effect of VIA-2291 100 mg relative to placebo on the change from baseline in the target (plaque) to background (blood) ratio (TBR) from an index vessel (either right carotid, left carotid or ascending aorta) based on the standardized 18fluorodeoxy glucose (FDG) uptake measured with PET in patients with acute coronary syndrome and vascular inflammation after 24 weeks of daily dosing.
1 secondary outcome
Change From Baseline in Plaque Imaging After 6 Weeks
Time frame: Baseline and 6 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25752438Gaztanaga J, Farkouh M, Rudd JH, Brotz TM, Rosenbaum D, Mani V, Kerwin TC, Taub R, Tardif JC, Tawakol A, Fayad ZA. A phase 2 randomized, double-blind, placebo-controlled study of the effect of VIA-2291, a 5-lipoxygenase inhibitor, on vascular inflammation in patients after an acute coronary syndrome. Atherosclerosis. 2015 May;240(1):53-60. doi: 10.1016/j.atherosclerosis.2015.02.027. Epub 2015 Feb 24.
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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.
Rebecca Taub, MD study director
VIA Pharmaceuticals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VIA-2291 in people with Acute Coronary Syndrome, run by Tallikut Pharmaceuticals, Inc. at 2 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 4 inclusion and 10 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 9 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 9 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Plaque Imaging After 24 Weeks (time frame: Baseline and 24 Weeks). 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 NCT00552188, 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 9 Aug 2013.