Trial Outcomes & Findings for Evaluate the Utility of 18FDG-PET as a Tool to Quantify Atherosclerotic Plaque (MK-0000-081 AM3)(COMPLETED) (NCT NCT00703261)
NCT ID: NCT00703261
Last Updated: 2015-10-09
Results Overview
Vascular plaque inflammation was measured by 18FDG-PET imaging. Uptake of FDG by the carotid and thoracic aorta is expressed as the target, vessel wall to background, lumen ratio (TBR). TBRmax of an axial cross section of a vessel (a slice) is defined as the maximum TBR within a slice and TBRmeanmax is the mean of TBRmax for all slices in the qualifying segment. The qualifying segment is the left or right carotid or thoracic aorta with the greatest FDG uptake value at Baseline.
COMPLETED
PHASE1
83 participants
Baseline and Week 12
2015-10-09
Participant Flow
Participant milestones
| Measure |
10 mg Atorvastatin
Participants self-administered one 10 mg atorvastatin tablet and one 80 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.
|
80 mg Atorvastatin
Participants self-administered one 80 mg atorvastatin tablet and one 10 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
41
|
|
Overall Study
COMPLETED
|
36
|
35
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluate the Utility of 18FDG-PET as a Tool to Quantify Atherosclerotic Plaque (MK-0000-081 AM3)(COMPLETED)
Baseline characteristics by cohort
| Measure |
10 mg Atorvastatin
n=42 Participants
Participants self-administered one 10 mg atorvastatin tablet and one 80 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.
|
80 mg Atorvastatin
n=41 Participants
Participants self-administered one 80 mg atorvastatin tablet and one 10 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.0 years
STANDARD_DEVIATION 9.63 • n=39 Participants
|
59.1 years
STANDARD_DEVIATION 9.24 • n=41 Participants
|
59.5 years
STANDARD_DEVIATION 9.40 • n=35 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=39 Participants
|
32 Participants
n=41 Participants
|
65 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: The analysis population includes all participants who completed the study and had complete image sets with usable data.
Vascular plaque inflammation was measured by 18FDG-PET imaging. Uptake of FDG by the carotid and thoracic aorta is expressed as the target, vessel wall to background, lumen ratio (TBR). TBRmax of an axial cross section of a vessel (a slice) is defined as the maximum TBR within a slice and TBRmeanmax is the mean of TBRmax for all slices in the qualifying segment. The qualifying segment is the left or right carotid or thoracic aorta with the greatest FDG uptake value at Baseline.
Outcome measures
| Measure |
10 mg Atorvastatin
n=33 Participants
Participants self-administered one 10 mg atorvastatin tablet and one matching 80 mg atorvastatin placebo tablet orally once daily for 12 weeks.
|
80 mg Atorvastatin
n=34 Participants
Participants self-administered one 80 mg atorvastatin tablet and one matching 10 mg atorvastatin placebo tablet orally once daily for 12 weeks.
|
|---|---|---|
|
Percent Reduction From Baseline in TBRmeanmax of the Qualifying Segment
|
1.4 Percent reduction
Interval -2.6 to 5.3
|
5.8 Percent reduction
Interval 2.0 to 9.5
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The analysis population includes all statin-naive participants who completed the study and had complete image sets.
Vascular plaque inflammation was measured by 18FDG-PET imaging. Uptake of FDG by the carotid and thoracic aorta is expressed as the target, vessel wall to background, lumen ratio (TBR). TBRmax of an axial cross section of a vessel (a slice) is defined as the maximum TBR within a slice and TBRmeanmax is the mean of TBRmax for all slices in the qualifying segment. The qualifying segment is the left or right carotid or thoracic aorta with the greatest FDG uptake value at Baseline.
Outcome measures
| Measure |
10 mg Atorvastatin
n=27 Participants
Participants self-administered one 10 mg atorvastatin tablet and one matching 80 mg atorvastatin placebo tablet orally once daily for 12 weeks.
|
80 mg Atorvastatin
Participants self-administered one 80 mg atorvastatin tablet and one matching 10 mg atorvastatin placebo tablet orally once daily for 12 weeks.
|
|---|---|---|
|
Percent Reduction From Baseline in TBRmeanmax of the Qualifying Segment in Statin-naive Participants
|
2.3 Percent reduction
Interval -2.1 to 6.5
|
—
|
Adverse Events
10 mg Atorvastatin
80 mg Atorvastatin
Serious adverse events
| Measure |
10 mg Atorvastatin
n=42 participants at risk
Participants self-administered one 10 mg atorvastatin tablet and one 80 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.
|
80 mg Atorvastatin
n=41 participants at risk
Participants self-administered one 80 mg atorvastatin tablet and one 10 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.
|
|---|---|---|
|
General disorders
Chest Pain
|
2.4%
1/42
|
0.00%
0/41
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/42
|
2.4%
1/41
|
Other adverse events
| Measure |
10 mg Atorvastatin
n=42 participants at risk
Participants self-administered one 10 mg atorvastatin tablet and one 80 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.
|
80 mg Atorvastatin
n=41 participants at risk
Participants self-administered one 80 mg atorvastatin tablet and one 10 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.
|
|---|---|---|
|
Investigations
Alanine Aminotransferase Increased
|
2.4%
1/42
|
7.3%
3/41
|
|
Investigations
Blood Creatinine Phosphokinase Increased
|
9.5%
4/42
|
4.9%
2/41
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/42
|
7.3%
3/41
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication guidelines.
- Publication restrictions are in place
Restriction type: OTHER