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| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
| Icahn School of Medicine at Mount Sinai | OTHER |
| University of Massachusetts, Worcester | OTHER |
| Winthrop University Hospital |
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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.
The effect of VIA-2291 on vascular inflammation will be assessed through 18FDG PET vascular imaging measurements and various biomarkers after 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VIA-2291 | Experimental | VIA-2291 100mg |
|
| Placebo | Placebo Comparator | Matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIA-2291 | Drug | 100 mg, oral dosing, 1 time daily for 24 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 6 Weeks |
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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 |
|---|---|---|---|---|---|---|
| VIA Pharmaceuticals | San Francisco | California | 94111 | United States | ||
| VIA Pharmaceuticals |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25752438 | Derived | 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. |
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Subjects had Acute Coronory Syndrome (ACS) 1-3 months prior to randomization and must have received concomitant statin therapy for a minimum of 4 weeks and had a stable statin dose regimen for 2 weeks prior to randomization.
Patients were screened between November 2007 and April 2009
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| ID | Title | Description |
|---|---|---|
| FG000 | VIA-2291 | VIA-2291 100mg |
| FG001 | Placebo | Matching placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | VIA-2291 | VIA-2291 100mg |
| BG001 | Placebo | Matching placebo |
| BG002 |
| 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 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. | Evaluable Population | Posted | Least Squares Mean | 95% Confidence Interval | TBR | Baseline and 24 Weeks |
|
24 Weeks
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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 | VIA-2291 100mg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Unstable | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Pectoris | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Cunningham, MD | Tallikut Pharmaceuticals, Inc. | 312-505-0420 | brian@baycitycapital.com |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C096921 | atreleuton |
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| OTHER |
| Montreal Heart Institute | OTHER |
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| Placebo |
| Drug |
oral dosing, 1 time daily for 24 weeks |
|
| Princeton |
| New Jersey |
| 08540 |
| United States |
| Withdrawal of consent |
|
| Subject returned to home country |
|
| 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 |
|
|
|
|
| Secondary | 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. | Evaluable Population | Posted | Least Squares Mean | 95% Confidence Interval | TBR | Baseline and 6 Weeks |
|
|
|
|
| 5 |
| 26 |
| 15 |
| 26 |
| EG001 | Placebo | Matching placebo | 5 | 26 | 17 | 26 |
| Angina Pectoris | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
|
| In-Stent Coronary Artery Restenosis | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
|
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Chest Pain | General disorders | MedDRA (10.1) | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (10.1) | Systematic Assessment |
|
| Peripheral Arterial Occlusive Disease | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
|
| Sinus Bradycardia | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
|
| Chest Pain | General disorders | MedDRA (10.1) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (10.1) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (10.1) | Systematic Assessment |
|
| Low Density Lipoprotein Increased | Investigations | MedDRA (10.1) | Systematic Assessment |
|
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (10.1) | Systematic Assessment |
|
| Angina Unstable | Cardiac disorders | MedDRA (10.1) | 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 prior to publishing individual site results.
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |