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Study Effect of VIA-2291 on Vascular Inflammation

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00358826
Enrollment
191
Registered
2006-08-01
Start date
2006-07-31
Completion date
2008-09-30
Last updated
2012-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Brief 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

Detailed description

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

Interventions

DRUGVIA-2291

oral dosing, 1 time daily for 12 or 24 weeks

DRUGPlacebo

oral dosing, 1 time daily for 12 or 24 weeks

Sponsors

Montreal Heart Institute
CollaboratorOTHER
Tallikut Pharmaceuticals, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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 * 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

Design outcomes

Primary

MeasureTime frame
Change From Baseline on ex Vivo Leukotriene B4 Synthesis in Whole BloodBaseline and 12 weeks

Secondary

MeasureTime frameDescription
Change From Baseline in Leukotriene E4 (LTE4)Baseline and 12 weeksUrinary LTE4 is expressed in pg per mg Creatinine (pg/mg Cr) to normalize for renal excretion rate
Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - Core StudyBaseline and 12 weeks—

Other

MeasureTime frameDescription
Change From Baseline in Percent StenosisBaseline and 24 weeks—
Change From Baseline in Mean Plaque DensityBaseline and 24 weeksPlaque density is expressed in Hounsfield Units (HU)
Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - MDCT SubstudyBaseline and 24 weeks—
Change From Baseline in Noncalcified Plaque VolumeBaseline and 24 weeks—

Countries

Canada, United States

Participant flow

Recruitment details

Patients had an Acute Coronary Syndrome (ACS) within 3 weeks prior to randomization

Pre-assignment details

Subset of patients agreed to participate in a Multi-Detector Computed Tomography (MDCT) substudy for an additional 12 weeks of treatment for a total of 24 weeks

Participants by arm

ArmCount
VIA-2291 25 mg
VIA-2291, 25 mg, oral dosing, daily, 12 weeks
49
VIA-2291 50 mg
VIA-2291, 50 mg, oral dosing, daily, 12 weeks
46
VIA-2291 100 mg
VIA-2291, 100 mg, oral dosing, daily, 12 weeks
44
Placebo
Matching Placebo, oral dosing, 12 weeks
52
Total191

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006FG007
Core StudyAdverse Event13110000
Core StudyLost to Follow-up00010000
Core StudyPhysician Decision00100000
Core StudyWithdrawal by Subject22000000
MDCT SubstudyAdverse Event00001000
MDCT SubstudyLost to Follow-up00000100
MDCT SubstudyWithdrawal by Subject00000100

Baseline characteristics

CharacteristicVIA-2291 25 mgVIA-2291 50 mgVIA-2291 100 mgPlaceboTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
11 Participants11 Participants9 Participants11 Participants42 Participants
Age, Categorical
Between 18 and 65 years
38 Participants35 Participants35 Participants41 Participants149 Participants
Age Continuous56.4 years
STANDARD_DEVIATION 9.54
57.3 years
STANDARD_DEVIATION 10.01
57.6 years
STANDARD_DEVIATION 9.44
56.6 years
STANDARD_DEVIATION 9.78
57.0 years
STANDARD_DEVIATION 9.63
Region of Enrollment
Canada
34 participants33 participants31 participants34 participants132 participants
Region of Enrollment
United States
15 participants13 participants13 participants18 participants59 participants
Sex: Female, Male
Female
8 Participants5 Participants6 Participants11 Participants30 Participants
Sex: Female, Male
Male
41 Participants41 Participants38 Participants41 Participants161 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
42 / 4943 / 4642 / 4445 / 52
serious
Total, serious adverse events
4 / 493 / 467 / 445 / 52

Outcome results

Primary

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

Time frame: Baseline and 12 weeks

Population: Core Study Evaluable Population

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
VIA-2291 25 mgChange From Baseline on ex Vivo Leukotriene B4 Synthesis in Whole Blood-88126 pg/mL95% Confidence Interval 29.95
VIA-2291 50 mgChange From Baseline on ex Vivo Leukotriene B4 Synthesis in Whole Blood-95703 pg/mL95% Confidence Interval 31.01
VIA-2291 100 mgChange From Baseline on ex Vivo Leukotriene B4 Synthesis in Whole Blood-122668 pg/mL95% Confidence Interval 7.01
PlaceboChange From Baseline on ex Vivo Leukotriene B4 Synthesis in Whole Blood-20843 pg/mL95% Confidence Interval 174.12
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
Secondary

Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - Core Study

Time frame: Baseline and 12 weeks

Population: Evaluable Population

ArmMeasureValue (MEDIAN)
VIA-2291 25 mgChange From Baseline in High Sensitivity C-reactive Protein (hsCRP) - Core Study-0.2 mg/L
VIA-2291 50 mgChange From Baseline in High Sensitivity C-reactive Protein (hsCRP) - Core Study-0.1 mg/L
VIA-2291 100 mgChange From Baseline in High Sensitivity C-reactive Protein (hsCRP) - Core Study-0.3 mg/L
PlaceboChange From Baseline in High Sensitivity C-reactive Protein (hsCRP) - Core Study-0.2 mg/L
p-value: 0.656ANCOVA
p-value: 0.863ANCOVA
p-value: 0.996ANCOVA
Secondary

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

Time frame: Baseline and 12 weeks

Population: Core Study Evaluable Population

ArmMeasureValue (LEAST_SQUARES_MEAN)
VIA-2291 25 mgChange From Baseline in Leukotriene E4 (LTE4)-26.8 pg/mg Cr
VIA-2291 50 mgChange From Baseline in Leukotriene E4 (LTE4)-38.6 pg/mg Cr
VIA-2291 100 mgChange From Baseline in Leukotriene E4 (LTE4)-56.5 pg/mg Cr
PlaceboChange From Baseline in Leukotriene E4 (LTE4)8.4 pg/mg Cr
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
Other Pre-specified

Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - MDCT Substudy

Time frame: Baseline and 24 weeks

Population: Evaluable Population of the MDCT substudy

ArmMeasureValue (MEDIAN)
VIA-2291 25 mgChange From Baseline in High Sensitivity C-reactive Protein (hsCRP) - MDCT Substudy-0.4 mg/L
VIA-2291 50 mgChange From Baseline in High Sensitivity C-reactive Protein (hsCRP) - MDCT Substudy-0.2 mg/L
VIA-2291 100 mgChange From Baseline in High Sensitivity C-reactive Protein (hsCRP) - MDCT Substudy-0.4 mg/L
PlaceboChange From Baseline in High Sensitivity C-reactive Protein (hsCRP) - MDCT Substudy0.0 mg/L
p-value: 0.331ANCOVA
p-value: 0.606ANCOVA
p-value: <0.001ANOVA
Other Pre-specified

Change From Baseline in Mean Plaque Density

Plaque density is expressed in Hounsfield Units (HU)

Time frame: Baseline and 24 weeks

Population: Evaluable Population

ArmMeasureValue (LEAST_SQUARES_MEAN)
VIA-2291 25 mgChange From Baseline in Mean Plaque Density19.11 HU
VIA-2291 50 mgChange From Baseline in Mean Plaque Density7.39 HU
VIA-2291 100 mgChange From Baseline in Mean Plaque Density12.22 HU
PlaceboChange From Baseline in Mean Plaque Density12.42 HU
p-value: 0.92ANCOVA
p-value: 0.96ANCOVA
p-value: 1ANCOVA
Other Pre-specified

Change From Baseline in Noncalcified Plaque Volume

Time frame: Baseline and 24 weeks

Population: Evaluable Population

ArmMeasureValue (LEAST_SQUARES_MEAN)
VIA-2291 25 mgChange From Baseline in Noncalcified Plaque Volume-1.55 mm^3
VIA-2291 50 mgChange From Baseline in Noncalcified Plaque Volume-5.6 mm^3
VIA-2291 100 mgChange From Baseline in Noncalcified Plaque Volume0.15 mm^3
PlaceboChange From Baseline in Noncalcified Plaque Volume2.83 mm^3
p-value: 0.22ANCOVA
p-value: <0.005ANCOVA
p-value: 0.6ANCOVA
Other Pre-specified

Change From Baseline in Percent Stenosis

Time frame: Baseline and 24 weeks

Population: Evaluable Population

ArmMeasureValue (LEAST_SQUARES_MEAN)
VIA-2291 25 mgChange From Baseline in Percent Stenosis-0.11 Percentage
VIA-2291 50 mgChange From Baseline in Percent Stenosis11.45 Percentage
VIA-2291 100 mgChange From Baseline in Percent Stenosis2.36 Percentage
PlaceboChange From Baseline in Percent Stenosis1.19 Percentage
p-value: 0.99ANCOVA
p-value: 0.11ANCOVA
p-value: 0.99ANCOVA

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026