Study Effect of VIA-2291 on Vascular Inflammation

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ClinicalTrials.gov Identifier: NCT00358826

Recruitment Status : Completed

First Posted : August 1, 2006

Results First Posted : July 23, 2012

Last Update Posted : July 23, 2012

Sponsor:

Collaborator:

Montreal Heart Institute

Information provided by (Responsible Party):

Tallikut Pharmaceuticals, Inc.

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition	Coronary Artery Disease
Interventions	Drug: VIA-2291 Drug: Placebo
Enrollment	191

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


Arm/Group Title	VIA-2291 25 mg	VIA-2291 50 mg	VIA-2291 100 mg	Placebo	VIA-2291 25 mg MDCT Substudy	VIA-2291 50 mg MDCT Substudy	VIA-2291 100 mg MDCT Substudy	Placebo MDCT Substudy
Arm/Group Description	VIA-2291, 25 mg, oral dosing, daily...	VIA-2291, 50 mg, oral dosing, daily...	VIA-2291, 100 mg, oral dosing, dail...	Matching Placebo, 12 weeks	VIA-2291, 25 mg, oral dosing, daily...	VIA-2291, 50 mg, oral dosing, daily...	VIA-2291, 100 mg, oral dosing, dail...	Matching Placebo, 24 weeks
Arm/Group Description	VIA-2291, 25 mg, oral dosing, daily, 12 weeks	VIA-2291, 50 mg, oral dosing, daily, 12 weeks	VIA-2291, 100 mg, oral dosing, daily, 12 weeks	Matching Placebo, 12 weeks	VIA-2291, 25 mg, oral dosing, daily, 24 weeks	VIA-2291, 50 mg, oral dosing, daily, 24 weeks	VIA-2291, 100 mg, oral dosing, daily, 24 weeks	Matching Placebo, 24 weeks
Period Title: Core Study
Started	49	46	44	52	0	0	0	0
Completed	46	41	42	50	0	0	0	0
Not Completed	3	5	2	2	0	0	0	0
Reason Not Completed
Adverse Event	1	3	1	1	0	0	0	0
Withdrawal by Subject	2	2	0	0	0	0	0	0
Lost to Follow-up	0	0	0	1	0	0	0	0
Physician Decision	0	0	1	0	0	0	0	0
Period Title: MDCT Substudy
Started	0	0	0	0	25	22	19	27
Completed	0	0	0	0	24	20	19	27
Not Completed	0	0	0	0	1	2	0	0
Reason Not Completed
Adverse Event	0	0	0	0	1	0	0	0
Lost to Follow-up	0	0	0	0	0	1	0	0
Withdrawal by Subject	0	0	0	0	0	1	0	0

Baseline Characteristics

Arm/Group Title		VIA-2291 25 mg	VIA-2291 50 mg	VIA-2291 100 mg	Placebo	Total
Arm/Group Description		VIA-2291, 25 mg, oral dosing, daily...	VIA-2291, 50 mg, oral dosing, daily...	VIA-2291, 100 mg, oral dosing, dail...	Matching Placebo, oral dosing, 12 w...	Total of all reporting groups
Arm/Group Description		VIA-2291, 25 mg, oral dosing, daily, 12 weeks	VIA-2291, 50 mg, oral dosing, daily, 12 weeks	VIA-2291, 100 mg, oral dosing, daily, 12 weeks	Matching Placebo, oral dosing, 12 weeks	Total of all reporting groups
Overall Number of Baseline Participants		49	46	44	52	191
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	49 participants	46 participants	44 participants	52 participants	191 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	38 77.6%	35 76.1%	35 79.5%	41 78.8%	149 78.0%
	>=65 years	11 22.4%	11 23.9%	9 20.5%	11 21.2%	42 22.0%
Age Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	49 participants	46 participants	44 participants	52 participants	191 participants
		56.4 (9.54)	57.3 (10.01)	57.6 (9.44)	56.6 (9.78)	57.0 (9.63)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	49 participants	46 participants	44 participants	52 participants	191 participants
	Female	8 16.3%	5 10.9%	6 13.6%	11 21.2%	30 15.7%
	Male	41 83.7%	41 89.1%	38 86.4%	41 78.8%	161 84.3%
Region of Enrollment Measure Type: Number Unit of measure: Participants	Number Analyzed	49 participants	46 participants	44 participants	52 participants	191 participants
Canada		34	33	31	34	132
United States		15	13	13	18	59

Outcome Measures

1.Primary Outcome


Title	Change From Baseline on ex Vivo Leukotriene B4 Synthesis in Whole Blood
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

Core Study Evaluable Population


Arm/Group Title	VIA-2291 25 mg	VIA-2291 50 mg	VIA-2291 100 mg	Placebo
Arm/Group Description:	VIA-2291, 25 mg, oral dosing, daily...	VIA-2291, 50 mg, oral dosing, daily...	VIA-2291, 100 mg, oral dosing, dail...	Matching Placebo, oral dosing, 12 w...
Arm/Group Description:	VIA-2291, 25 mg, oral dosing, daily, 12 weeks	VIA-2291, 50 mg, oral dosing, daily, 12 weeks	VIA-2291, 100 mg, oral dosing, daily, 12 weeks	Matching Placebo, oral dosing, 12 weeks
Overall Number of Participants Analyzed	43	36	38	45
Least Squares Mean (95% Confidence Interval) Unit of Measure: pg/mL
	-88126 (-100056 to -76196)	-95703 (-108810 to -82597)	-122668 (-135359 to -109976)	-20843 (-32509 to -9179)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	VIA-2291 25 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.001
	Comments	Adjusted using Dunnett's method.
	Method	ANCOVA
	Comments	The model included treatment effect, with baseline value as a covariate.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	VIA-2291 50 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.001
	Comments	Adjusted using Dunnett's method.
	Method	ANCOVA
	Comments	The model included treatment effect, with baseline value as a covariate.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	VIA-2291 100 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.001
	Comments	Adjusted using Dunnett's method.
	Method	ANCOVA
	Comments	The model included treatment effect, with baseline value as a covariate.

2.Secondary Outcome


Title	Change From Baseline in Leukotriene E4 (LTE4)
Description	Urinary LTE4 is expressed in pg per mg Creatinine (pg/mg Cr) to normal...
Description	Urinary LTE4 is expressed in pg per mg Creatinine (pg/mg Cr) to normalize for renal excretion rate
Time Frame	Baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

Core Study Evaluable Population


Arm/Group Title	VIA-2291 25 mg	VIA-2291 50 mg	VIA-2291 100 mg	Placebo
Arm/Group Description:	VIA-2291, 25 mg, oral dosing, daily...	VIA-2291, 50 mg, oral dosing, daily...	VIA-2291, 100 mg, oral dosing, dail...	Matching Placebo, oral dosing, 12 w...
Arm/Group Description:	VIA-2291, 25 mg, oral dosing, daily, 12 weeks	VIA-2291, 50 mg, oral dosing, daily, 12 weeks	VIA-2291, 100 mg, oral dosing, daily, 12 weeks	Matching Placebo, oral dosing, 12 weeks
Overall Number of Participants Analyzed	42	38	35	44
Least Squares Mean (95% Confidence Interval) Unit of Measure: pg/mg Cr
	-26.8 (-39.3 to -14.4)	-38.6 (-51.7 to -25.5)	-56.5 (-70.2 to -42.9)	8.4 (-3.8 to 20.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	VIA-2291 25 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.001
	Comments	Adjusted using Dunnett's method.
	Method	ANCOVA
	Comments	The model included treatment effect, with baseline value as a covariate.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	VIA-2291 50 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.001
	Comments	Adjusted using Dunnett's method.
	Method	ANCOVA
	Comments	The model included treatment effect, with baseline value as a covariate.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	VIA-2291 100 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.001
	Comments	Adjusted using Dunnett's method.
	Method	ANCOVA
	Comments	The model included treatment effect, with baseline value as a covariate.

3.Secondary Outcome


Title	Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - Core Study
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

Evaluable Population


Arm/Group Title	VIA-2291 25 mg	VIA-2291 50 mg	VIA-2291 100 mg	Placebo
Arm/Group Description:	VIA-2291, 25 mg, oral dosing, daily...	VIA-2291, 50 mg, oral dosing, daily...	VIA-2291, 100 mg, oral dosing, dail...	Matching Placebo, oral dosing, 12 w...
Arm/Group Description:	VIA-2291, 25 mg, oral dosing, daily, 12 weeks	VIA-2291, 50 mg, oral dosing, daily, 12 weeks	VIA-2291, 100 mg, oral dosing, daily, 12 weeks	Matching Placebo, oral dosing, 12 weeks
Overall Number of Participants Analyzed	44	38	38	48
Median (Inter-Quartile Range) Unit of Measure: mg/L
	-0.2 (-1.1 to 0.4)	-0.1 (-1.9 to 0.1)	-0.3 (-0.8 to 0.1)	-0.2 (-0.9 to 0.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	VIA-2291 25 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.656
	Comments	Adjusted using Dunnett's method.
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	VIA-2291 50 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.863
	Comments	Adjusted using Dunnett's method.
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	VIA-2291 100 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.996
	Comments	Adjusted using Dunnett's method.
	Method	ANCOVA
	Comments	[Not Specified]

4.Other Pre-specified Outcome


Title	Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - MDCT Substudy
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Baseline and 24 weeks

Outcome Measure Data

Analysis Population Description

Evaluable Population of the MDCT substudy


Arm/Group Title	VIA-2291 25 mg MDCT Substudy	VIA-2291 50 mg MDCT Substudy	VIA-2291 100 mg MDCT Substudy	Placebo MDCT Substudy
Arm/Group Description:	VIA-2291, 25 mg, oral dosing, daily...	VIA-2291, 50 mg, oral dosing, daily...	VIA-2291, 100 mg, oral dosing, dail...	Matching Placebo, oral dosing, 24 w...
Arm/Group Description:	VIA-2291, 25 mg, oral dosing, daily, 24 weeks	VIA-2291, 50 mg, oral dosing, daily, 24 weeks	VIA-2291, 100 mg, oral dosing, daily, 24 weeks	Matching Placebo, oral dosing, 24 weeks
Overall Number of Participants Analyzed	23	20	18	27
Median (Inter-Quartile Range) Unit of Measure: mg/L
	-0.4 (-1.2 to 0.3)	-0.2 (-3.7 to 0.2)	-0.4 (-3.9 to -0.2)	0.0 (-0.5 to 1.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	VIA-2291 25 mg MDCT Substudy, Placebo MDCT Substudy
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.331
	Comments	Adjusted using Dunnett's method.
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	VIA-2291 50 mg MDCT Substudy, Placebo MDCT Substudy
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.606
	Comments	Adjusted using Dunnett's method.
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	VIA-2291 100 mg MDCT Substudy, Placebo MDCT Substudy
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.001
	Comments	Adjusted using Dunnett's method.
	Method	ANOVA
	Comments	[Not Specified]

5.Other Pre-specified Outcome


Title	Change From Baseline in Noncalcified Plaque Volume
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Baseline and 24 weeks

Outcome Measure Data

Analysis Population Description

Evaluable Population


Arm/Group Title	VIA-2291 25 mg MDCT Substudy	VIA-2291 50 mg MDCT Substudy	VIA-2291 100 mg MDCT Substudy	Placebo MDCT Substudy
Arm/Group Description:	VIA-2291, 25 mg, oral dosing, daily...	VIA-2291, 50 mg, oral dosing, daily...	VIA-2291, 100 mg, oral dosing, dail...	Matching Placebo, oral dosing, 24 w...
Arm/Group Description:	VIA-2291, 25 mg, oral dosing, daily, 24 weeks	VIA-2291, 50 mg, oral dosing, daily, 24 weeks	VIA-2291, 100 mg, oral dosing, daily, 24 weeks	Matching Placebo, oral dosing, 24 weeks
Overall Number of Participants Analyzed	7	8	7	12
Least Squares Mean (95% Confidence Interval) Unit of Measure: mm^3
	-1.55 (-5.62 to 2.51)	-5.6 (-9.49 to -1.71)	0.15 (-3.84 to 4.14)	2.83 (-0.18 to 5.84)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	VIA-2291 25 mg MDCT Substudy, Placebo MDCT Substudy
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.22
	Comments	Dunnett test compared with Placebo
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	VIA-2291 50 mg MDCT Substudy, Placebo MDCT Substudy
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.005
	Comments	Dunnett test compared with Placebo
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	VIA-2291 100 mg MDCT Substudy, Placebo MDCT Substudy
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.60
	Comments	Dunnett test compared with Placebo
	Method	ANCOVA
	Comments	[Not Specified]

6.Other Pre-specified Outcome


Title	Change From Baseline in Mean Plaque Density
Description	Plaque density is expressed in Hounsfield Units (HU)
Description	Plaque density is expressed in Hounsfield Units (HU)
Time Frame	Baseline and 24 weeks

Outcome Measure Data

Analysis Population Description

Evaluable Population


Arm/Group Title	VIA-2291 25 mg	VIA-2291 50 mg	VIA-2291 100 mg	Placebo
Arm/Group Description:	VIA-2291, 25 mg, oral dosing, daily...	VIA-2291, 50 mg, oral dosing, daily...	VIA-2291, 100 mg, oral dosing, dail...	Matching Placebo, oral dosing, 12 w...
Arm/Group Description:	VIA-2291, 25 mg, oral dosing, daily, 12 weeks	VIA-2291, 50 mg, oral dosing, daily, 12 weeks	VIA-2291, 100 mg, oral dosing, daily, 12 weeks	Matching Placebo, oral dosing, 12 weeks
Overall Number of Participants Analyzed	7	8	7	12
Least Squares Mean (95% Confidence Interval) Unit of Measure: HU
	19.11 (-1.51 to 39.74)	7.39 (-11.96 to 26.74)	12.22 (-8.38 to 32.82)	12.42 (-3.32 to 28.17)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	VIA-2291 25 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.92
	Comments	Dunnett test compared with Placebo
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	VIA-2291 50 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.96
	Comments	Dunnett test compared with Placebo
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	VIA-2291 100 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	1.00
	Comments	Dunnett test compared with Placebo
	Method	ANCOVA
	Comments	[Not Specified]

7.Other Pre-specified Outcome


Title	Change From Baseline in Percent Stenosis
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Baseline and 24 weeks

Outcome Measure Data

Analysis Population Description

Evaluable Population


Arm/Group Title	VIA-2291 25 mg	VIA-2291 50 mg	VIA-2291 100 mg	Placebo
Arm/Group Description:	VIA-2291, 25 mg, oral dosing, daily...	VIA-2291, 50 mg, oral dosing, daily...	VIA-2291, 100 mg, oral dosing, dail...	Matching Placebo, oral dosing, 12 w...
Arm/Group Description:	VIA-2291, 25 mg, oral dosing, daily, 12 weeks	VIA-2291, 50 mg, oral dosing, daily, 12 weeks	VIA-2291, 100 mg, oral dosing, daily, 12 weeks	Matching Placebo, oral dosing, 12 weeks
Overall Number of Participants Analyzed	7	8	7	12
Least Squares Mean (95% Confidence Interval) Unit of Measure: Percentage
	-0.11 (-8.24 to 8.03)	11.45 (3.73 to 19.17)	2.36 (-5.7 to 10.42)	1.19 (-4.95 to 7.32)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	VIA-2291 25 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.99
	Comments	Dunnett test compared with Placebo
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	VIA-2291 50 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.11
	Comments	Dunnett test compared with Placebo
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	VIA-2291 100 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.99
	Comments	Dunnett test compared with Placebo
	Method	ANCOVA
	Comments	[Not Specified]

Adverse Events

Time Frame	12 weeks for Core Study and 24 weeks for MDCT substudy
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	VIA-2291 25 mg		VIA-2291 50 mg		VIA-2291 100 mg		Placebo
Arm/Group Description	VIA-2291, 25 mg, oral dosing, daily...		VIA-2291, 50 mg, oral dosing, daily...		VIA-2291, 100 mg, oral dosing, dail...		Matching Placebo, oral dosing, 12 w...
Arm/Group Description	VIA-2291, 25 mg, oral dosing, daily, 12 weeks		VIA-2291, 50 mg, oral dosing, daily, 12 weeks		VIA-2291, 100 mg, oral dosing, daily, 12 weeks		Matching Placebo, oral dosing, 12 weeks
All-Cause Mortality
	VIA-2291 25 mg		VIA-2291 50 mg		VIA-2291 100 mg		Placebo
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--		--/--		--/--
Serious Adverse Events Serious Adverse Events
	VIA-2291 25 mg		VIA-2291 50 mg		VIA-2291 100 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/49 (8.16%)		3/46 (6.52%)		7/44 (15.91%)		5/52 (9.62%)
Cardiac disorders
Angina Unstable ^† 1	1/49 (2.04%)	1	0/46 (0.00%)	0	2/44 (4.55%)	2	0/52 (0.00%)	0
Angina Pectoris ^† 1	0/49 (0.00%)	0	1/46 (2.17%)	1	1/44 (2.27%)	1	0/52 (0.00%)	0
Cardiac Failure Congestive ^† 1	1/49 (2.04%)	1	0/0	0	0/44 (0.00%)	0	1/52 (1.92%)	1
Coronary Artery Disease ^† 1	0/49 (0.00%)	0	1/46 (2.17%)	1	0/44 (0.00%)	0	0/52 (0.00%)	0
Pericardial Effusion ^† 1	0/49 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1	0/52 (0.00%)	0
Acute Coronary Syndrome ^† 1	0/49 (0.00%)	0	0/46 (0.00%)	0	0/44 (0.00%)	0	1/52 (1.92%)	1
Eye disorders
Retinal Detachment ^† 1	0/49 (0.00%)	0	0/46 (0.00%)	0	0/44 (0.00%)	0	1/52 (1.92%)	1
Gastrointestinal disorders
Colitis Ischaemic ^† 1	0/49 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1	0/52 (0.00%)	0
General disorders
Non-cardiac Chest Pain ^† 1	1/49 (2.04%)	1	0/46 (0.00%)	0	1/44 (2.27%)	1	0/52 (0.00%)	0
Chest Discomfort ^† 1	0/49 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1	0/52 (0.00%)	0
Chest Pain ^† 1	0/49 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1	0/52 (0.00%)	0
Pneumonia ^† 1	0/49 (0.00%)	0	0/46 (0.00%)	0	0/44 (0.00%)	0	1/52 (1.92%)	1
Infections and infestations
Bronchitis ^† 1	0/49 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1	0/52 (0.00%)	0
Diverticulitis ^† 1	0/49 (0.00%)	0	0/46 (0.00%)	0	1/44 (2.27%)	1	0/52 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-hodgkin's Lymphoma ^† 1	0/49 (0.00%)	0	0/46 (0.00%)	0	0/44 (0.00%)	0	1/52 (1.92%)	1
Nervous system disorders
Presyncope ^† 1	0/49 (0.00%)	0	1/46 (2.17%)	1	0/44 (0.00%)	0	0/52 (0.00%)	0
Syncope ^† 1	1/49 (2.04%)	1	0/46 (0.00%)	0	0/44 (0.00%)	0	0/52 (0.00%)	0
Vascular disorders
Accelerated Hypertension ^† 1	1/49 (2.04%)	1	0/46 (0.00%)	0	0/44 (0.00%)	0	0/52 (0.00%)	0
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA (9.0)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	VIA-2291 25 mg		VIA-2291 50 mg		VIA-2291 100 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	42/49 (85.71%)		43/46 (93.48%)		42/44 (95.45%)		45/52 (86.54%)
Cardiac disorders
Angina Pectoris ^† 1	3/49 (6.12%)	3	8/46 (17.39%)	8	7/44 (15.91%)	7	5/52 (9.62%)	5
Gastrointestinal disorders
Nausea ^† 1	3/49 (6.12%)	3	1/46 (2.17%)	1	4/44 (9.09%)	4	1/52 (1.92%)	1
Dspepsia ^† 1	3/49 (6.12%)	3	1/46 (2.17%)	1	3/44 (6.82%)	3	1/52 (1.92%)	1
General disorders
Fatigue ^† 1	4/49 (8.16%)	4	6/46 (13.04%)	6	7/44 (15.91%)	7	5/52 (9.62%)	5
Non-cardiac Chest Pain ^† 1	5/49 (10.20%)	5	3/46 (6.52%)	3	4/44 (9.09%)	4	4/52 (7.69%)	4
Chest pain ^† 1	3/49 (6.12%)	3	2/46 (4.35%)	2	2/44 (4.55%)	2	0/52 (0.00%)	0
Infections and infestations
Nasopharyngitis ^† 1	1/49 (2.04%)	1	5/46 (10.87%)	5	0/44 (0.00%)	0	4/52 (7.69%)	4
Upper Respiratory Tract Infection ^† 1	2/49 (4.08%)	2	2/46 (4.35%)	2	1/44 (2.27%)	1	4/52 (7.69%)	4
Injury, poisoning and procedural complications
Contusion ^† 1	5/49 (10.20%)	5	2/46 (4.35%)	2	4/44 (9.09%)	4	7/52 (13.46%)	7
Investigations
Alanine Aminotransferase Increased ^† 1	5/49 (10.20%)	5	1/46 (2.17%)	1	1/44 (2.27%)	1	3/52 (5.77%)	3
Blood Glucose Increased ^† 1	0/49 (0.00%)	0	0/46 (0.00%)	0	0/44 (0.00%)	0	4/52 (7.69%)	4
Musculoskeletal and connective tissue disorders
Pain in Extremity ^† 1	7/49 (14.29%)	7	4/46 (8.70%)	4	5/44 (11.36%)	5	4/52 (7.69%)	4
Back Pain ^† 1	3/49 (6.12%)	3	5/46 (10.87%)	5	0/44 (0.00%)	0	3/52 (5.77%)	3
Arthralgia ^† 1	4/49 (8.16%)	4	0/46 (0.00%)	0	3/44 (6.82%)	3	1/52 (1.92%)	1
Musculoskeletal pain ^† 1	2/49 (4.08%)	2	3/46 (6.52%)	3	1/44 (2.27%)	1	0/52 (0.00%)	0
Myalgia ^† 1	4/49 (8.16%)	4	0/46 (0.00%)	0	2/44 (4.55%)	2	2/52 (3.85%)	2
Nervous system disorders
Headache ^† 1	5/49 (10.20%)	5	5/46 (10.87%)	5	5/44 (11.36%)	5	6/52 (11.54%)	6
Dizziness ^† 1	1/49 (2.04%)	1	3/46 (6.52%)	3	7/44 (15.91%)	7	5/52 (9.62%)	5
Psychiatric disorders
Insomnia ^† 1	2/49 (4.08%)	2	0/46 (0.00%)	0	4/44 (9.09%)	4	2/52 (3.85%)	2
Depression ^† 1	0/49 (0.00%)	0	1/46 (2.17%)	1	4/44 (9.09%)	4	1/52 (1.92%)	1
Respiratory, thoracic and mediastinal disorders
Epistaxis ^† 1	1/49 (2.04%)	1	3/46 (6.52%)	3	7/44 (15.91%)	7	2/52 (3.85%)	2
Dyspnoea Exertional ^† 1	3/49 (6.12%)	3	2/46 (4.35%)	2	4/44 (9.09%)	4	0/52 (0.00%)	0
Dyspnoea ^† 1	1/49 (2.04%)	1	5/46 (10.87%)	5	1/44 (2.27%)	1	2/52 (3.85%)	2
Oropharyngeal Pain ^† 1	0/49 (0.00%)	0	3/46 (6.52%)	3	0/44 (0.00%)	0	0/52 (0.00%)	0
Cough ^† 1	3/49 (6.12%)	3	2/46 (4.35%)	2	1/44 (2.27%)	1	1/52 (1.92%)	1
Skin and subcutaneous tissue disorders
Ecchymosis ^† 1	4/49 (8.16%)	4	4/46 (8.70%)	4	4/44 (9.09%)	4	3/52 (5.77%)	3
Pruritus ^† 1	2/49 (4.08%)	2	1/46 (2.17%)	1	4/44 (9.09%)	4	0/52 (0.00%)	0
Vascular disorders
Hypertension ^† 1	1/49 (2.04%)	1	4/46 (8.70%)	4	1/44 (2.27%)	1	1/52 (1.92%)	1
Hypotension ^† 1	2/49 (4.08%)	2	1/46 (2.17%)	1	2/44 (4.55%)	2	3/52 (5.77%)	3
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA (9.0)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented as a joint, multi-center publication.

Results Point of Contact

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Name/Title:	Brian Cunningham, MD
Organization:	Tallikut Pharmaceuticals, Inc.
Phone:	312-505-0420
EMail:	brian@baycitycapital.com

Publications:

Tardif JC, L'allier PL, Ibrahim R, Grégoire 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Matsumoto S, Ibrahim R, Grégoire 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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Responsible Party:	Tallikut Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00358826
Other Study ID Numbers:	VIA-2291-01
First Submitted:	July 28, 2006
First Posted:	August 1, 2006
Results First Submitted:	June 15, 2012
Results First Posted:	July 23, 2012
Last Update Posted:	July 23, 2012

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