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| Name | Class |
|---|---|
| Montreal Heart Institute | OTHER |
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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
This is a Phase II, randomized, double-blind, placebo-controlled study of the effect of VIA-2291 on atherosclerotic vascular inflammation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VIA-2291 25 mg | Experimental | VIA-2291 25 mg |
|
| VIA-2291 50 mg | Experimental | VIA-2291 50 mg |
|
| VIA-2291 100 mg | Experimental | VIA-2291 100 mg |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIA-2291 | Drug | oral dosing, 1 time daily for 12 or 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline on ex Vivo Leukotriene B4 Synthesis in Whole Blood | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and 12 weeks |
| Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - Core Study |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - MDCT Substudy | Baseline and 24 weeks | |
| Change From Baseline in Noncalcified Plaque Volume | Baseline and 24 weeks | |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Taub, MD | VIA Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MIMA Century Research Associates | Melbourne | Florida | 32901 | United States | ||
| Minneapolis Heart Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20190281 | Background | 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. | |
| 27883201 |
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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
Patients had an Acute Coronary Syndrome (ACS) within 3 weeks prior to randomization
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| ID | Title | Description |
|---|---|---|
| FG000 | VIA-2291 25 mg | VIA-2291, 25 mg, oral dosing, daily, 12 weeks |
| FG001 | VIA-2291 50 mg | VIA-2291, 50 mg, oral dosing, daily, 12 weeks |
| FG002 | VIA-2291 100 mg | VIA-2291, 100 mg, oral dosing, daily, 12 weeks |
| FG003 | Placebo | Matching Placebo, 12 weeks |
| FG004 | VIA-2291 25 mg MDCT Substudy | VIA-2291, 25 mg, oral dosing, daily, 24 weeks |
| FG005 | VIA-2291 50 mg MDCT Substudy | VIA-2291, 50 mg, oral dosing, daily, 24 weeks |
| FG006 | VIA-2291 100 mg MDCT Substudy | VIA-2291, 100 mg, oral dosing, daily, 24 weeks |
| FG007 | Placebo MDCT Substudy | Matching Placebo, 24 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Core Study |
|
| ||||||||||||||||||
| MDCT Substudy |
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | VIA-2291 25 mg | VIA-2291, 25 mg, oral dosing, daily, 12 weeks |
| BG001 | VIA-2291 50 mg | VIA-2291, 50 mg, oral dosing, daily, 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline on ex Vivo Leukotriene B4 Synthesis in Whole Blood | Core Study Evaluable Population | Posted | Least Squares Mean | 95% Confidence Interval | pg/mL | Baseline and 12 weeks |
|
12 weeks for Core Study and 24 weeks for MDCT substudy
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VIA-2291 25 mg | VIA-2291, 25 mg, oral dosing, daily, 12 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Unstable | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA (9.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Cunningham, MD | Tallikut Pharmaceuticals, Inc. | 312-505-0420 | brian@baycitycapital.com |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C096921 | atreleuton |
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| Placebo | Drug | oral dosing, 1 time daily for 12 or 24 weeks |
|
| Baseline and 12 weeks |
| Change From Baseline in Mean Plaque Density |
Plaque density is expressed in Hounsfield Units (HU) |
| Baseline and 24 weeks |
| Change From Baseline in Percent Stenosis | Baseline and 24 weeks |
| Minneapolis |
| Minnesota |
| 55407 |
| United States |
| Cardiology Associates Research, LLC | Tupelo | Mississippi | 38801 | United States |
| LeBauer Cardiovascular Research Foundation | Greensboro | North Carolina | 27401 | United States |
| Victoria Heart and Vascular Center | Victoria | Texas | 77901 | United States |
| Foothills Medical Center | Calgary | Alberta | T2N 2T9 | Canada |
| Victoria Heart Institute Foundation | Victoria | British Columbia | V8R 4R2 | Canada |
| Queen Elizabeth II HSC | Halifax | Nova Scotia | B3H 3A7 | Canada |
| Montreal Heart Institute | Montreal | Quebec | H1T 1C8 | Canada |
| Notre Dame Hospital | Montreal | Quebec | H2L 4M1 | Canada |
| Hospital Sacre-Coeur | Montreal | Quebec | H4J 1C5 | Canada |
| Constituante Centre Hospitalier Regional De Lanaudiere | Saint-Charles-Borromée | Quebec | J6E 6J2 | Canada |
| 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. |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Physician Decision |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | VIA-2291 100 mg | VIA-2291, 100 mg, oral dosing, daily, 12 weeks |
| BG003 | Placebo | Matching Placebo, oral dosing, 12 weeks |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG003 | Placebo | Matching Placebo, oral dosing, 12 weeks |
|
|
|
| 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 | Core Study Evaluable Population | Posted | Least Squares Mean | 95% Confidence Interval | pg/mg Cr | Baseline and 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - Core Study | Evaluable Population | Posted | Median | Inter-Quartile Range | mg/L | Baseline and 12 weeks |
|
|
|
|
| Other Pre-specified | Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - MDCT Substudy | Evaluable Population of the MDCT substudy | Posted | Median | Inter-Quartile Range | mg/L | Baseline and 24 weeks |
|
|
|
|
| Other Pre-specified | Change From Baseline in Noncalcified Plaque Volume | Evaluable Population | Posted | Least Squares Mean | 95% Confidence Interval | mm^3 | Baseline and 24 weeks |
|
|
|
|
| Other Pre-specified | Change From Baseline in Mean Plaque Density | Plaque density is expressed in Hounsfield Units (HU) | Evaluable Population | Posted | Least Squares Mean | 95% Confidence Interval | HU | Baseline and 24 weeks |
|
|
|
|
| Other Pre-specified | Change From Baseline in Percent Stenosis | Evaluable Population | Posted | Least Squares Mean | 95% Confidence Interval | Percentage | Baseline and 24 weeks |
|
|
|
|
| 4 |
| 49 |
| 42 |
| 49 |
| EG001 | VIA-2291 50 mg | VIA-2291, 50 mg, oral dosing, daily, 12 weeks | 3 | 46 | 43 | 46 |
| EG002 | VIA-2291 100 mg | VIA-2291, 100 mg, oral dosing, daily, 12 weeks | 7 | 44 | 42 | 44 |
| EG003 | Placebo | Matching Placebo, oral dosing, 12 weeks | 5 | 52 | 45 | 52 |
| Angina Pectoris | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
|
| Cardiac Failure Congestive | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
|
| Coronary Artery Disease | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
|
| Pericardial Effusion | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
|
| Acute Coronary Syndrome | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
|
| Non-cardiac Chest Pain | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| Chest Discomfort | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| Chest Pain | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
|
| Pneumonia | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Colitis Ischaemic | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Accelerated Hypertension | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
|
| Retinal Detachment | Eye disorders | MedDRA (9.0) | Systematic Assessment |
|
| Non-hodgkin's Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Systematic Assessment |
|
| Non-cardiac Chest Pain | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Dspepsia | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Angina Pectoris | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
|
| Alanine Aminotransferase Increased | Investigations | MedDRA (9.0) | Systematic Assessment |
|
| Blood Glucose Increased | Investigations | MedDRA (9.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
|
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.
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
The model included treatment effect, with baseline value as a covariate. |
| <0.001 |
Adjusted using Dunnett's method. |
| No |
| Superiority or Other |
| ANCOVA | The model included treatment effect, with baseline value as a covariate. | <0.001 | Adjusted using Dunnett's method. | No | Superiority or Other |
Adjusted using Dunnett's method. |
| No |
| Superiority or Other |
| ANCOVA | 0.996 | Adjusted using Dunnett's method. | No | Superiority or Other |
Adjusted using Dunnett's method. |
| No |
| Superiority or Other |
| ANOVA | <0.001 | Adjusted using Dunnett's method. | No | Superiority or Other |
Dunnett test compared with Placebo |
| No |
| Superiority or Other |
| ANCOVA | 0.60 | Dunnett test compared with Placebo | No | Superiority or Other |
Dunnett test compared with Placebo |
| No |
| Superiority or Other |
| ANCOVA | 1.00 | Dunnett test compared with Placebo | No | Superiority or Other |
Dunnett test compared with Placebo |
| No |
| Superiority or Other |
| ANCOVA | 0.99 | Dunnett test compared with Placebo | No | Superiority or Other |