Trial Outcomes & Findings for Study Effect of VIA-2291 on Atherosclerotic Vascular Inflammation in Patients Undergoing Elective Carotid Endarterectomy (NCT NCT00352417)
NCT ID: NCT00352417
Last Updated: 2012-07-27
Results Overview
Effect of VIA-2291 100-mg relative to placebo after 12 weeks of daily dosing on the percent cross-sectional area of macrophages in plaque tissue using an anti-CD68 antibody
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
12 weeks
Results posted on
2012-07-27
Participant Flow
Patients recruited from three Italian Medical Centers
Participant milestones
| Measure |
VIA-2291
100-mg dose
|
Matching Placebo
Placebo Dose
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
26
|
|
Overall Study
COMPLETED
|
19
|
21
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
VIA-2291
100-mg dose
|
Matching Placebo
Placebo Dose
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Schedule Change
|
2
|
1
|
Baseline Characteristics
Study Effect of VIA-2291 on Atherosclerotic Vascular Inflammation in Patients Undergoing Elective Carotid Endarterectomy
Baseline characteristics by cohort
| Measure |
VIA-2291
n=24 Participants
100-mg dose
|
Matching Placebo
n=26 Participants
Placebo Dose
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age Continuous
|
66.8 years
STANDARD_DEVIATION 8.86 • n=5 Participants
|
69.5 years
STANDARD_DEVIATION 8.73 • n=7 Participants
|
68.2 years
STANDARD_DEVIATION 8.81 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
24 participants
n=5 Participants
|
26 participants
n=7 Participants
|
50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Evaluable Population with histological sections available
Effect of VIA-2291 100-mg relative to placebo after 12 weeks of daily dosing on the percent cross-sectional area of macrophages in plaque tissue using an anti-CD68 antibody
Outcome measures
| Measure |
VIA-2291
n=12 Participants
100-mg dose
|
Matching Placebo
n=13 Participants
Placebo Dose
|
|---|---|---|
|
Percent Cross-sectional Area of Macrophages in Plaque Tissue
|
8.08 Percent Area
Interval 4.3 to 11.9
|
8.19 Percent Area
Interval 3.8 to 12.6
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Evaluable Population with histological sections available
Effect of VIA-2291 100-mg relative to placebo after 12 weeks of daily dosing on the percent cross-sectional area of anti-5-Lipoxygenase staining in plaque tissue
Outcome measures
| Measure |
VIA-2291
n=12 Participants
100-mg dose
|
Matching Placebo
n=13 Participants
Placebo Dose
|
|---|---|---|
|
Percent Cross-sectional Area of Anti-5-Lipoxygenase Staining in Plaque Tissue
|
1.80 Percent Area
Interval -0.3 to 3.9
|
0.87 Percent Area
Interval 0.1 to 1.6
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Evaluable Population
Outcome measures
| Measure |
VIA-2291
n=16 Participants
100-mg dose
|
Matching Placebo
n=19 Participants
Placebo Dose
|
|---|---|---|
|
Change From Baseline in Whole Blood Leukotriene B4 Production
|
-123,000 pg/ml
|
-42,900 pg/ml
|
SECONDARY outcome
Timeframe: Baseline and 12 WeeksPopulation: Evaluable Population
Outcome measures
| Measure |
VIA-2291
n=14 Participants
100-mg dose
|
Matching Placebo
n=14 Participants
Placebo Dose
|
|---|---|---|
|
Change From Baseline in Urine Leukotriene E4 Adjusted for Creatinine
|
-64.7 Percent Change
Interval -75.7 to -48.7
|
-15.5 Percent Change
Interval -41.8 to 22.8
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Evaluable population with both baseline and visit 8 results
Outcome measures
| Measure |
VIA-2291
n=15 Participants
100-mg dose
|
Matching Placebo
n=15 Participants
Placebo Dose
|
|---|---|---|
|
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP)
|
-2.0 mg/L
Interval -3.1 to -0.9
|
0.2 mg/L
Interval -0.9 to 1.3
|
Adverse Events
VIA-2291
Serious events: 4 serious events
Other events: 18 other events
Deaths: 0 deaths
Matching Placebo
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VIA-2291
n=24 participants at risk
100-mg dose
|
Matching Placebo
n=26 participants at risk
Placebo Dose
|
|---|---|---|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK SECOND DEGREE
|
4.2%
1/24 • Number of events 1 • 12 weeks
|
0.00%
0/26 • 12 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BENIGN RENAL NEOPLASM
|
0.00%
0/24 • 12 weeks
|
3.8%
1/26 • Number of events 1 • 12 weeks
|
|
Investigations
BLOOD CREATININE INCREASED
|
4.2%
1/24 • Number of events 1 • 12 weeks
|
0.00%
0/26 • 12 weeks
|
|
Investigations
BLOOD UREA INCREASED
|
4.2%
1/24 • Number of events 1 • 12 weeks
|
0.00%
0/26 • 12 weeks
|
|
Nervous system disorders
PRESYNCOPE
|
4.2%
1/24 • Number of events 1 • 12 weeks
|
0.00%
0/26 • 12 weeks
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
4.2%
1/24 • Number of events 1 • 12 weeks
|
0.00%
0/26 • 12 weeks
|
Other adverse events
| Measure |
VIA-2291
n=24 participants at risk
100-mg dose
|
Matching Placebo
n=26 participants at risk
Placebo Dose
|
|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
4.2%
1/24 • Number of events 1 • 12 weeks
|
0.00%
0/26 • 12 weeks
|
|
Blood and lymphatic system disorders
ANAEMIA
|
4.2%
1/24 • Number of events 1 • 12 weeks
|
0.00%
0/26 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
BLISTER
|
0.00%
0/24 • 12 weeks
|
3.8%
1/26 • Number of events 1 • 12 weeks
|
|
Investigations
BLOOD AMYLASE INCREASED
|
4.2%
1/24 • Number of events 1 • 12 weeks
|
0.00%
0/26 • 12 weeks
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
4.2%
1/24 • Number of events 1 • 12 weeks
|
0.00%
0/26 • 12 weeks
|
|
Investigations
BLOOD BILIRUBIN UNCONJUGATED INCREASED
|
4.2%
1/24 • Number of events 1 • 12 weeks
|
0.00%
0/26 • 12 weeks
|
|
Investigations
BLOOD CREATININE INCREASED
|
8.3%
2/24 • Number of events 2 • 12 weeks
|
0.00%
0/26 • 12 weeks
|
|
Investigations
BLOOD GLUCOSE INCREASED
|
8.3%
2/24 • Number of events 2 • 12 weeks
|
0.00%
0/26 • 12 weeks
|
|
Investigations
BLOOD UREA INCREASED
|
12.5%
3/24 • Number of events 3 • 12 weeks
|
0.00%
0/26 • 12 weeks
|
|
Eye disorders
CATARACT
|
0.00%
0/24 • 12 weeks
|
3.8%
1/26 • Number of events 1 • 12 weeks
|
|
Infections and infestations
CYSTITIS
|
8.3%
2/24 • Number of events 2 • 12 weeks
|
3.8%
1/26 • Number of events 1 • 12 weeks
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.00%
0/24 • 12 weeks
|
3.8%
1/26 • Number of events 1 • 12 weeks
|
|
Gastrointestinal disorders
DIARRHOEA
|
8.3%
2/24 • Number of events 2 • 12 weeks
|
3.8%
1/26 • Number of events 1 • 12 weeks
|
|
Nervous system disorders
DIZZINESS
|
—
0/0 • 12 weeks
|
3.8%
1/26 • Number of events 1 • 12 weeks
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/24 • 12 weeks
|
3.8%
1/26 • Number of events 1 • 12 weeks
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
4.2%
1/24 • Number of events 1 • 12 weeks
|
0.00%
0/26 • 12 weeks
|
|
Gastrointestinal disorders
GASTRITIS
|
4.2%
1/24 • Number of events 1 • 12 weeks
|
0.00%
0/26 • 12 weeks
|
|
Renal and urinary disorders
GLYCOSURIA
|
4.2%
1/24 • Number of events 1 • 12 weeks
|
0.00%
0/26 • 12 weeks
|
|
Metabolism and nutrition disorders
GOUT
|
0.00%
0/24 • 12 weeks
|
3.8%
1/26 • Number of events 1 • 12 weeks
|
|
Nervous system disorders
HEADACHE
|
4.2%
1/24 • Number of events 1 • 12 weeks
|
3.8%
1/26 • Number of events 1 • 12 weeks
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/24 • 12 weeks
|
3.8%
1/26 • Number of events 1 • 12 weeks
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
4.2%
1/24 • Number of events 1 • 12 weeks
|
0.00%
0/26 • 12 weeks
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
4.2%
1/24 • Number of events 1 • 12 weeks
|
0.00%
0/26 • 12 weeks
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
4.2%
1/24 • Number of events 1 • 12 weeks
|
0.00%
0/26 • 12 weeks
|
|
Investigations
LIPASE INCREASED
|
4.2%
1/24 • Number of events 1 • 12 weeks
|
0.00%
0/26 • 12 weeks
|
|
Gastrointestinal disorders
MESENTERIC ARTERY STENOSIS
|
4.2%
1/24 • Number of events 1 • 12 weeks
|
0.00%
0/26 • 12 weeks
|
|
Nervous system disorders
NEURALGIA
|
0.00%
0/24 • 12 weeks
|
3.8%
1/26 • Number of events 1 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGOLARYNGEAL PAIN
|
0.00%
0/24 • 12 weeks
|
3.8%
1/26 • Number of events 1 • 12 weeks
|
|
Injury, poisoning and procedural complications
POSTOPERATIVE FEVER
|
0.00%
0/24 • 12 weeks
|
3.8%
1/26 • Number of events 1 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.00%
0/24 • 12 weeks
|
3.8%
1/26 • Number of events 1 • 12 weeks
|
|
General disorders
PYREXIA
|
12.5%
3/24 • Number of events 3 • 12 weeks
|
0.00%
0/26 • 12 weeks
|
|
Infections and infestations
RHINITIS
|
4.2%
1/24 • Number of events 1 • 12 weeks
|
0.00%
0/26 • 12 weeks
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
0.00%
0/24 • 12 weeks
|
3.8%
1/26 • Number of events 1 • 12 weeks
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/24 • 12 weeks
|
3.8%
1/26 • Number of events 1 • 12 weeks
|
|
Metabolism and nutrition disorders
TYPE 2 DIABETES MELLITUS
|
4.2%
1/24 • Number of events 1 • 12 weeks
|
0.00%
0/26 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PIs agreed to allow the sponsor 30 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.
- Publication restrictions are in place
Restriction type: OTHER