Trial Outcomes & Findings for Phase 2 Study in Vascular Inflammation on Patients After an Acute Coronary Syndrome Event (NCT NCT00552188)
NCT ID: NCT00552188
Last Updated: 2013-08-09
Results Overview
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.
COMPLETED
PHASE2
52 participants
Baseline and 24 Weeks
2013-08-09
Participant Flow
Patients were screened between November 2007 and April 2009
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.
Participant milestones
| Measure |
VIA-2291
VIA-2291 100mg
|
Placebo
Matching placebo
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
26
|
|
Overall Study
COMPLETED
|
24
|
21
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
| Measure |
VIA-2291
VIA-2291 100mg
|
Placebo
Matching placebo
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Withdrawal of consent
|
0
|
1
|
|
Overall Study
Subject returned to home country
|
0
|
1
|
Baseline Characteristics
Phase 2 Study in Vascular Inflammation on Patients After an Acute Coronary Syndrome Event
Baseline characteristics by cohort
| Measure |
VIA-2291
n=26 Participants
VIA-2291 100mg
|
Placebo
n=26 Participants
Matching placebo
|
Total
n=52 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
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age Continuous
|
56.2 years
STANDARD_DEVIATION 9.50 • n=5 Participants
|
58.7 years
STANDARD_DEVIATION 8.00 • n=7 Participants
|
57.4 years
STANDARD_DEVIATION 8.79 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
16 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 WeeksPopulation: Evaluable Population
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.
Outcome measures
| Measure |
VIA-2291
n=24 Participants
VIA-2291 100mg
|
Placebo
n=21 Participants
Matching placebo
|
|---|---|---|
|
Change From Baseline in Plaque Imaging After 24 Weeks
|
-0.01 TBR
95% Confidence Interval 11.19 • Interval -0.08 to 0.06
|
-0.06 TBR
95% Confidence Interval 11.92 • Interval -0.14 to 0.02
|
SECONDARY outcome
Timeframe: Baseline and 6 WeeksPopulation: Evaluable Population
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.
Outcome measures
| Measure |
VIA-2291
n=24 Participants
VIA-2291 100mg
|
Placebo
n=21 Participants
Matching placebo
|
|---|---|---|
|
Change From Baseline in Plaque Imaging After 6 Weeks
|
0.01 TBR
95% Confidence Interval 8.37 • Interval -0.07 to 0.08
|
-0.07 TBR
95% Confidence Interval 9.5 • Interval -0.14 to 0.01
|
Adverse Events
VIA-2291
Placebo
Serious adverse events
| Measure |
VIA-2291
n=26 participants at risk
VIA-2291 100mg
|
Placebo
n=26 participants at risk
Matching placebo
|
|---|---|---|
|
Cardiac disorders
Angina Unstable
|
7.7%
2/26 • 24 Weeks
|
3.8%
1/26 • 24 Weeks
|
|
Cardiac disorders
Angina Pectoris
|
3.8%
1/26 • 24 Weeks
|
3.8%
1/26 • 24 Weeks
|
|
Cardiac disorders
Atrial Fibrillation
|
3.8%
1/26 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
|
Cardiac disorders
In-Stent Coronary Artery Restenosis
|
3.8%
1/26 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/26 • 24 Weeks
|
3.8%
1/26 • 24 Weeks
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/26 • 24 Weeks
|
3.8%
1/26 • 24 Weeks
|
|
General disorders
Chest Pain
|
3.8%
1/26 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/26 • 24 Weeks
|
3.8%
1/26 • 24 Weeks
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.00%
0/26 • 24 Weeks
|
3.8%
1/26 • 24 Weeks
|
Other adverse events
| Measure |
VIA-2291
n=26 participants at risk
VIA-2291 100mg
|
Placebo
n=26 participants at risk
Matching placebo
|
|---|---|---|
|
Cardiac disorders
Angina Pectoris
|
15.4%
4/26 • 24 Weeks
|
11.5%
3/26 • 24 Weeks
|
|
Cardiac disorders
Sinus Bradycardia
|
11.5%
3/26 • 24 Weeks
|
3.8%
1/26 • 24 Weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
11.5%
3/26 • 24 Weeks
|
3.8%
1/26 • 24 Weeks
|
|
Gastrointestinal disorders
Constipation
|
7.7%
2/26 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/26 • 24 Weeks
|
7.7%
2/26 • 24 Weeks
|
|
Nervous system disorders
Headache
|
7.7%
2/26 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
|
Nervous system disorders
Paraesthesia
|
7.7%
2/26 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
|
General disorders
Chest Pain
|
11.5%
3/26 • 24 Weeks
|
3.8%
1/26 • 24 Weeks
|
|
General disorders
Asthenia
|
0.00%
0/26 • 24 Weeks
|
7.7%
2/26 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
7.7%
2/26 • 24 Weeks
|
3.8%
1/26 • 24 Weeks
|
|
Investigations
Low Density Lipoprotein Increased
|
7.7%
2/26 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
7.7%
2/26 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.8%
1/26 • 24 Weeks
|
7.7%
2/26 • 24 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.7%
2/26 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.7%
2/26 • 24 Weeks
|
7.7%
2/26 • 24 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/26 • 24 Weeks
|
7.7%
2/26 • 24 Weeks
|
|
Infections and infestations
Influenza
|
7.7%
2/26 • 24 Weeks
|
3.8%
1/26 • 24 Weeks
|
|
Vascular disorders
Hypotension
|
7.7%
2/26 • 24 Weeks
|
3.8%
1/26 • 24 Weeks
|
|
General disorders
Fatigue
|
0.00%
0/26 • 24 Weeks
|
19.2%
5/26 • 24 Weeks
|
|
Cardiac disorders
Angina Unstable
|
7.7%
2/26 • 24 Weeks
|
3.8%
1/26 • 24 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER