Coronary Artery DiseasePhase 2NCT00358826

Study Effect of VIA-2291 on Vascular Inflammation

A Phase 2 study testing VIA-2291 in people with Coronary Artery Disease, run by Tallikut Pharmaceuticals, Inc. at 12 sites in 2 countries.

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

This is a dose ranging study to compare the effect of VIA-2291 vs. Placebo on various inflammatory biomarkers in patients with recent acute coronary events Read more about this study

Who is it for?: Ages 30 to 80 years
Conditions the study is for: Coronary Artery Disease
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: 191 participants
Where: 12 sitesin 2 countries
Study dates: Jul 2006to Sep 2008
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 30 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Female patients are to be of non-childbearing potential
Patient has suffered an ST elevation myocardial infarction (MI), non-ST elevation MI, or unstable angina 21 days (±3 days) prior to study randomization
Patient has documented coronary artery disease

Who cannot join

Renal insufficiency defined as creatinine >1.5 x upper limit of normal (ULN)
Cirrhosis, recent hepatitis, ALT >1.5 x ULN or ALT > 1 x ULN and at least one other liver function test
Uncontrolled diabetes mellitus within 1 month prior to study screening
Congestive heart failure (CHF) defined by the New York Heart Association as functional Class III or IV
Previous coronary artery bypass graft (CABG) surgery
Planned additional cardiac intervention

Show all 9Show fewer

Recurrence of ST elevation MI, non-ST elevation MI, or unstable angina less than 18 days prior to randomization
Current atrial fibrillation, atrial flutter, or frequent premature ventricular contractions
Acetaminophen use in any form in the 7 days before enrollment

Trial locations and contacts

12 sites in 2 countries.

Country

City, postcode or hospital

12 sites in 2 countries

Canada7 sites

Foothills Medical Center
Calgary, Alberta, T2N 2T9
Queen Elizabeth II HSC
Halifax, Nova Scotia, B3H 3A7
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Notre Dame Hospital
Montreal, Quebec, H2L 4M1
Hospital Sacre-Coeur
Montreal, Quebec, H4J 1C5
Constituante Centre Hospitalier Regional De Lanaudiere
Saint-Charles-Borromée, Quebec, J6E 6J2
Victoria Heart Institute Foundation
Victoria, British Columbia, V8R 4R2

Other trials in Canada

United States5 sites

LeBauer Cardiovascular Research Foundation
Greensboro, North Carolina, 27401
MIMA Century Research Associates
Melbourne, Florida, 32901
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
Cardiology Associates Research, LLC
Tupelo, Mississippi, 38801
Victoria Heart and Vascular Center
Victoria, Texas, 77901

Other trials in United States

About this study

Official title: Clinical Study Protocol No. VIA-2291-01, A Phase 2 Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose-ranging Study of the Effect of VIA-2291 on Vascular Inflammation in Patients After an Acute Coronary Syndrome Event

This is a dose ranging study to compare the effect of VIA-2291 vs. Placebo on various inflammatory biomarkers in patients with recent acute coronary events

Read the detailed description

This is a Phase II, randomized, double-blind, placebo-controlled study of the effect of VIA-2291 on atherosclerotic vascular inflammation

Conditions: Coronary Artery Disease
Being tested: VIA-2291, Placebo
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.

VIA-2291Drug
Also called atreleuton
oral dosing, 1 time daily for 12 or 24 weeks
PlaceboDrug
oral dosing, 1 time daily for 12 or 24 weeks

Study groups in NCT00358826
Study group	Role	What they receive
VIA-2291 25 mg	Experimental	VIA-2291 25 mg Receives: Drug: VIA-2291
VIA-2291 50 mg	Experimental	VIA-2291 50 mg Receives: Drug: VIA-2291
VIA-2291 100 mg	Experimental	VIA-2291 100 mg Receives: Drug: VIA-2291
Placebo	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

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

Change From Baseline on ex Vivo Leukotriene B4 Synthesis in Whole Blood
Measured: Baseline and 12 weeks

Secondary outcomes (2)

Change From Baseline in Leukotriene E4 (LTE4)
Urinary LTE4 is expressed in pg per mg Creatinine (pg/mg Cr) to normalize for renal excretion rate
Measured: Baseline and 12 weeks
Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - Core Study
Measured: Baseline and 12 weeks

Timeline

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

Jul 2006Sep 2008

First posted1 Aug 2006 (estimated)
Study startJul 2006
Primary completionAug 2008
Study completionSep 2008

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 (2)Papers the sponsor has linked to this study.
Other trials for Coronary Artery DiseaseStudies 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: 191 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00358826
Sponsor's protocol ID: VIA-2291-01
Status last verified: Jul 2012
First submitted: 28 Jul 2006
Last updated: 23 Jul 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Tardif JC, L'allier PL, Ibrahim R, Gregoire JC, Nozza A, Cossette M, Kouz S, Lavoie MA, Paquin J, Brotz TM, Taub R, Pressacco J. Treatment with 5-lipoxygenase inhibitor VIA-2291 (Atreleuton) in patients with recent acute coronary syndrome. Circ Cardiovasc Imaging. 2010 May;3(3):298-307. doi: 10.1161/CIRCIMAGING.110.937169. Epub 2010 Feb 27.
PubMed 20190281
Matsumoto S, Ibrahim R, Gregoire JC, L'Allier PL, Pressacco J, Tardif JC, Budoff MJ. Effect of treatment with 5-lipoxygenase inhibitor VIA-2291 (atreleuton) on coronary plaque progression: a serial CT angiography study. Clin Cardiol. 2017 Apr;40(4):210-215. doi: 10.1002/clc.22646. Epub 2016 Nov 24.
PubMed 27883201

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study Protocol No. VIA-2291-01, A Phase 2 Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose-ranging Study of the Effect of VIA-2291 on Vascular Inflammation in Patients After an Acute Coronary Syndrome Event
ClinicalTrials.gov ID: NCT00358826
Acronym / sponsor ID: VIA-2291-01
Conditions: Coronary Artery Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 191 participants (actual)
Lead sponsor: Tallikut Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Collaborators: Montreal Heart Institute
Study start: Jul 2006
Primary completion: Aug 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 1 Aug 2006 (estimated)
Results: Posted 23 Jul 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a dose ranging study to compare the effect of VIA-2291 vs. Placebo on various inflammatory biomarkers in patients with recent acute coronary events

Detailed description

This is a Phase II, randomized, double-blind, placebo-controlled study of the effect of VIA-2291 on atherosclerotic vascular inflammation

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
VIA-2291 25 mg	Experimental	Drug: VIA-2291VIA-2291 25 mg
VIA-2291 50 mg	Experimental	Drug: VIA-2291VIA-2291 50 mg
VIA-2291 100 mg	Experimental	Drug: VIA-2291VIA-2291 100 mg
Placebo	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

Ages: 30 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Female patients are to be of non-childbearing potential
Patient has suffered an ST elevation myocardial infarction (MI), non-ST elevation MI, or unstable angina 21 days (±3 days) prior to study randomization
Patient has documented coronary artery disease

Key exclusion criteria (9 listed)

Renal insufficiency defined as creatinine >1.5 x upper limit of normal (ULN)
Cirrhosis, recent hepatitis, ALT >1.5 x ULN or ALT > 1 x ULN and at least one other liver function test
Uncontrolled diabetes mellitus within 1 month prior to study screening
Congestive heart failure (CHF) defined by the New York Heart Association as functional Class III or IV
Previous coronary artery bypass graft (CABG) 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
VIA-2291Also: atreleutonoral dosing, 1 time daily for 12 or 24 weeks	Drug	VIA-2291 100 mg, VIA-2291 25 mg, VIA-2291 50 mg
Placebooral dosing, 1 time daily for 12 or 24 weeks	Drug	Placebo

Primary outcome

Change From Baseline on ex Vivo Leukotriene B4 Synthesis in Whole Blood
Time frame: Baseline and 12 weeks

2 secondary outcomes

Change From Baseline in Leukotriene E4 (LTE4)
Time frame: Baseline and 12 weeks
Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - Core Study
Time frame: Baseline and 12 weeks

Results and safety

Results posted to the registry on 23 Jul 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
VIA-2291 25 mg	49	46
VIA-2291 50 mg	46	41
VIA-2291 100 mg	44	42
Placebo	52	50
VIA-2291 25 mg MDCT Substudy	0	0
VIA-2291 50 mg MDCT Substudy	0	0
VIA-2291 100 mg MDCT Substudy	0	0
Placebo MDCT Substudy	0	0

Primary outcome: Change From Baseline on ex Vivo Leukotriene B4 Synthesis in Whole Blood

Time frame: Baseline and 12 weeks. Least squares mean (95% Confidence Interval). Unit: pg/mL

Measure	VIA-2291 25 mg n = 43	VIA-2291 50 mg n = 36	VIA-2291 100 mg n = 38	Placebo n = 45
Value	-88126 (29.95)	-95703 (31.01)	-122668 (7.01)	-20843 (174.12)

VIA-2291 25 mg vs Placebo: p <0.001, ANCOVA
VIA-2291 50 mg vs Placebo: p <0.001, ANCOVA
VIA-2291 100 mg vs Placebo: p <0.001, ANCOVA

Population analysed: Core Study Evaluable Population

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks for Core Study and 24 weeks for MDCT substudy. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
VIA-2291 25 mg	4 of 49 (8.2%)	42 of 49 (85.7%)	Not reported
VIA-2291 50 mg	3 of 46 (6.5%)	43 of 46 (93.5%)	Not reported
VIA-2291 100 mg	7 of 44 (15.9%)	42 of 44 (95.5%)	Not reported
Placebo	5 of 52 (9.6%)	45 of 52 (86.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20190281Tardif JC, L'allier PL, Ibrahim R, Gregoire JC, Nozza A, Cossette M, Kouz S, Lavoie MA, Paquin J, Brotz TM, Taub R, Pressacco J. Treatment with 5-lipoxygenase inhibitor VIA-2291 (Atreleuton) in patients with recent acute coronary syndrome. Circ Cardiovasc Imaging. 2010 May;3(3):298-307. doi: 10.1161/CIRCIMAGING.110.937169. Epub 2010 Feb 27.
Derived from this study: PubMed 27883201Matsumoto S, Ibrahim R, Gregoire JC, L'Allier PL, Pressacco J, Tardif JC, Budoff MJ. Effect of treatment with 5-lipoxygenase inhibitor VIA-2291 (atreleuton) on coronary plaque progression: a serial CT angiography study. Clin Cardiol. 2017 Apr;40(4):210-215. doi: 10.1002/clc.22646. Epub 2016 Nov 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

12 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 VIA-2291 in people with Coronary Artery Disease, run by Tallikut Pharmaceuticals, Inc. at 12 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 3 inclusion and 9 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 23 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Canada, 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 23 Jul 2012). 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 on ex Vivo Leukotriene B4 Synthesis in Whole Blood (time frame: Baseline and 12 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 NCT00358826, which also lists 2 linked publications.

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 23 Jul 2012.