Trial Outcomes & Findings for Reduction in YEllow Plaque by Aggressive Lipid LOWering Therapy (NCT NCT01567826)
NCT ID: NCT01567826
Last Updated: 2017-05-19
Results Overview
The regression of yellow plaque content from the atherosclerotic lipid pool after statin therapy by utilizing NIR spectroscopy as compared from baseline to 6-8 weeks after intervention. Spectroscopic information obtained from raw spectra was transformed into a probability of lipid core that was mapped to a red-to-yellow color scale, with the low probability of lipid shown as red and the high probability of lipid shown as yellow. Analyses were performed offline using the Matlab-based software, as previously published. Yellow pixels within the analyzed segment were divided by all viable pixels to generate the lipid-core burden index (LCBI). The maximal value of LCBI for each nonculprit obstructive lesion was recorded and used for comparison.
COMPLETED
PHASE4
87 participants
at baseline and at 6-8 weeks after intervention
2017-05-19
Participant Flow
779 patients consecutive patients with chronic stable angina presenting for elective coronary angiography were screened from May 21, 2010 until Jan 10, 2012. 87 participants met criteria and were randomized.
Participant milestones
| Measure |
Standard of Care Lipid Therapy
standard-care lipid-lowering therapy: Zocor or Lipitor
standard of care lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.
Zocor, Lipitor \[any dose\] and Crestor \[less than 40mg\]
|
Aggressive Lipid Therapy
aggressive lipid therapy: Crestor
Aggressive lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
44
|
|
Overall Study
COMPLETED
|
40
|
42
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Standard of Care Lipid Therapy
standard-care lipid-lowering therapy: Zocor or Lipitor
standard of care lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.
Zocor, Lipitor \[any dose\] and Crestor \[less than 40mg\]
|
Aggressive Lipid Therapy
aggressive lipid therapy: Crestor
Aggressive lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
Baseline Characteristics
Reduction in YEllow Plaque by Aggressive Lipid LOWering Therapy
Baseline characteristics by cohort
| Measure |
Standard of Care Lipid Therapy
n=43 Participants
standard-care lipid-lowering therapy: Zocor or Lipitor
standard of care lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.
Zocor, Lipitor \[any dose\] and Crestor \[less than 40mg\]
|
Aggressive Lipid Therapy
n=44 Participants
aggressive lipid therapy: Crestor
Aggressive lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.9 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
64.4 years
STANDARD_DEVIATION 9.29 • n=7 Participants
|
63.6 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Current tobacco use
yes
|
4 participants
n=5 Participants
|
9 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Current tobacco use
no
|
39 participants
n=5 Participants
|
35 participants
n=7 Participants
|
74 participants
n=5 Participants
|
|
Hypertension
yes
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
80 participants
n=5 Participants
|
|
Hypertension
no
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Hypercholesterolemia
yes
|
40 participants
n=5 Participants
|
39 participants
n=7 Participants
|
79 participants
n=5 Participants
|
|
Hypercholesterolemia
no
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Diabetes mellitus
yes
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Diabetes mellitus
no
|
40 participants
n=5 Participants
|
39 participants
n=7 Participants
|
79 participants
n=5 Participants
|
|
Prior CVA/TIA
yes
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Prior CVA/TIA
no
|
40 participants
n=5 Participants
|
42 participants
n=7 Participants
|
82 participants
n=5 Participants
|
|
Previous MI
yes
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Previous MI
no
|
35 participants
n=5 Participants
|
36 participants
n=7 Participants
|
71 participants
n=5 Participants
|
|
Previous PCI
yes
|
20 participants
n=5 Participants
|
16 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Previous PCI
no
|
23 participants
n=5 Participants
|
28 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Statin Use
yes
|
35 participants
n=5 Participants
|
37 participants
n=7 Participants
|
72 participants
n=5 Participants
|
|
Statin Use
no
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Beta-blocker use
yes
|
30 participants
n=5 Participants
|
33 participants
n=7 Participants
|
63 participants
n=5 Participants
|
|
Beta-blocker use
no
|
13 participants
n=5 Participants
|
11 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
ACE-I/ARB use
yes
|
19 participants
n=5 Participants
|
16 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
ACE-I/ARB use
no
|
24 participants
n=5 Participants
|
28 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Creatinine
|
1.1 mg/dl
STANDARD_DEVIATION 1.3 • n=5 Participants
|
1.0 mg/dl
STANDARD_DEVIATION 0.3 • n=7 Participants
|
1.04 mg/dl
STANDARD_DEVIATION 0.96 • n=5 Participants
|
|
LAD Coronary vessel
yes
|
17 participants
n=5 Participants
|
20 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
LAD Coronary vessel
no
|
26 participants
n=5 Participants
|
24 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
LCx coronary vessel
yes
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
LCx coronary vessel
no
|
29 participants
n=5 Participants
|
30 participants
n=7 Participants
|
59 participants
n=5 Participants
|
|
RCA coronary vessel
yes
|
13 participants
n=5 Participants
|
10 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
RCA coronary vessel
no
|
30 participants
n=5 Participants
|
34 participants
n=7 Participants
|
64 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at baseline and at 6-8 weeks after interventionPopulation: Data were not available in 17 patients because of loss to follow-up (n = 5), incorrect image formatting that could not be recovered at the time of core laboratory analysis (n = 5), NIRS console/catheter malfunction at the time of index PCI (n = 3), and loss of disc integrity or corruption before core laboratory analysis (n = 4).
The regression of yellow plaque content from the atherosclerotic lipid pool after statin therapy by utilizing NIR spectroscopy as compared from baseline to 6-8 weeks after intervention. Spectroscopic information obtained from raw spectra was transformed into a probability of lipid core that was mapped to a red-to-yellow color scale, with the low probability of lipid shown as red and the high probability of lipid shown as yellow. Analyses were performed offline using the Matlab-based software, as previously published. Yellow pixels within the analyzed segment were divided by all viable pixels to generate the lipid-core burden index (LCBI). The maximal value of LCBI for each nonculprit obstructive lesion was recorded and used for comparison.
Outcome measures
| Measure |
Standard of Care Lipid Therapy
n=34 Participants
standard-care lipid-lowering therapy: Zocor or Lipitor
standard of care lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.
Zocor, Lipitor \[any dose\] and Crestor \[less than 40mg\]
|
Aggressive Lipid Therapy
n=36 Participants
aggressive lipid therapy: Crestor
Aggressive lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.
|
|---|---|---|
|
Lipiscan - Lipid Core Burden Index (LCBI)
Baseline LCBI, lesion
|
95.4 ratio
Interval 29.6 to 174.6
|
132.4 ratio
Interval 99.0 to 201.2
|
|
Lipiscan - Lipid Core Burden Index (LCBI)
Follow-up LCBI, lesion
|
99.9 ratio
Interval 38.2 to 204.3
|
99.8 ratio
Interval 64.2 to 159.3
|
PRIMARY outcome
Timeframe: at baseline and at 6-8 weeks after interventionPopulation: Data were not available in 17 patients because of loss to follow-up (n = 5), incorrect image formatting that could not be recovered at the time of core laboratory analysis (n = 5), NIRS console/catheter malfunction at the time of index PCI (n = 3), and loss of disc integrity or corruption before core laboratory analysis (n = 4).
LCBI4mm max = change in lipid-core burden index at the 4-mm maximal segment. Spectroscopic information obtained from raw spectra was transformed into a probability of lipid core that was mapped to a red-to-yellow color scale, with the low probability of lipid shown as red and the high probability of lipid shown as yellow. Yellow pixels within the analyzed segment were divided by all viable pixels to generate the lipid-core burden index (LCBI). The maximal value of LCBI for each nonculprit obstructive lesion was recorded and used for comparison.
Outcome measures
| Measure |
Standard of Care Lipid Therapy
n=34 Participants
standard-care lipid-lowering therapy: Zocor or Lipitor
standard of care lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.
Zocor, Lipitor \[any dose\] and Crestor \[less than 40mg\]
|
Aggressive Lipid Therapy
n=36 Participants
aggressive lipid therapy: Crestor
Aggressive lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.
|
|---|---|---|
|
LCBI4mm Max
Baseline LCBI4mm max
|
356.7 ratio
Interval 145.2 to 509.2
|
490.6 ratio
Interval 363.8 to 689.7
|
|
LCBI4mm Max
Follow-up LCBI4mm max
|
385.7 ratio
Interval 139.2 to 510.9
|
336.1 ratio
Interval 252.3 to 479.9
|
PRIMARY outcome
Timeframe: at baseline and at 6-8 weeks after interventionPopulation: Data were not available in 17 patients because of loss to follow-up (n = 5), incorrect image formatting that could not be recovered at the time of core laboratory analysis (n = 5), NIRS console/catheter malfunction at the time of index PCI (n = 3), and loss of disc integrity or corruption before core laboratory analysis (n = 4).
Change in LCBI4mm max at 6-8 weeks after intervention as compared to baseline. LCBI4mm max = change in lipid-core burden index at the 4-mm maximal segment.
Outcome measures
| Measure |
Standard of Care Lipid Therapy
n=34 Participants
standard-care lipid-lowering therapy: Zocor or Lipitor
standard of care lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.
Zocor, Lipitor \[any dose\] and Crestor \[less than 40mg\]
|
Aggressive Lipid Therapy
n=36 Participants
aggressive lipid therapy: Crestor
Aggressive lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.
|
|---|---|---|
|
Change in LCBI4mm Max
|
2.4 ratio
Interval -36.1 to 44.7
|
-149.1 ratio
Interval -210.9 to -42.9
|
PRIMARY outcome
Timeframe: at baseline and at 6-8 weeks post interventionPopulation: Data were not available in 17 patients because of loss to follow-up (n = 5), incorrect image formatting that could not be recovered at the time of core laboratory analysis (n = 5), NIRS console/catheter malfunction at the time of index PCI (n = 3), and loss of disc integrity or corruption before core laboratory analysis (n = 4).
Change in LCBI at 6-8 weeks after intervention as compared to baseline
Outcome measures
| Measure |
Standard of Care Lipid Therapy
n=34 Participants
standard-care lipid-lowering therapy: Zocor or Lipitor
standard of care lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.
Zocor, Lipitor \[any dose\] and Crestor \[less than 40mg\]
|
Aggressive Lipid Therapy
n=36 Participants
aggressive lipid therapy: Crestor
Aggressive lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.
|
|---|---|---|
|
Change in LCBI, Lesion
|
8.0 ratio
Interval -7.7 to 22.1
|
-22.5 ratio
Interval -59.2 to -3.5
|
SECONDARY outcome
Timeframe: at baseline and at 6-8 weeks after interventionChange in atheroma volume and lumen CSA on IVUS as related to change in yellow plaque index as compared from baseline to 6-8 weeks after intervention. Data not analyzed. Data not available.
Outcome measures
| Measure |
Standard of Care Lipid Therapy
n=43 Participants
standard-care lipid-lowering therapy: Zocor or Lipitor
standard of care lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.
Zocor, Lipitor \[any dose\] and Crestor \[less than 40mg\]
|
Aggressive Lipid Therapy
n=44 Participants
aggressive lipid therapy: Crestor
Aggressive lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.
|
|---|---|---|
|
Intravascular Ultrasound (IVUS) Parameters
Baseline Total atheroma volume
|
193.7 mm^2
Standard Deviation 61.7
|
195.8 mm^2
Standard Deviation 63.3
|
|
Intravascular Ultrasound (IVUS) Parameters
6-8 weeks Total atheroma volume
|
199.6 mm^2
Standard Deviation 63.9
|
209.6 mm^2
Standard Deviation 74.1
|
|
Intravascular Ultrasound (IVUS) Parameters
Baseline Lumen CSA
|
2.4 mm^2
Standard Deviation 0.6
|
2.5 mm^2
Standard Deviation 0.8
|
|
Intravascular Ultrasound (IVUS) Parameters
6-8 weeks Lumen CSA
|
2.4 mm^2
Standard Deviation 0.7
|
2.5 mm^2
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: at baseline and at 6-8 weeks after interventionChange in FFR as related to change in yellow plaque index as compared from baseline to 6-8 weeks after intervention. Fractional flow reserve (FFR), defined as the ratio of maximum flow in the presence of a stenosis to normal maximum flow, is a lesion-specific index of stenosis severity that can be calculated by simultaneous measurement of mean arterial, distal coronary, and central venous pressure.
Outcome measures
| Measure |
Standard of Care Lipid Therapy
n=43 Participants
standard-care lipid-lowering therapy: Zocor or Lipitor
standard of care lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.
Zocor, Lipitor \[any dose\] and Crestor \[less than 40mg\]
|
Aggressive Lipid Therapy
n=44 Participants
aggressive lipid therapy: Crestor
Aggressive lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.
|
|---|---|---|
|
Fractional Flow Reserve (FFR) Value
Baseline
|
0.73 ratio
Standard Deviation 0.1
|
0.73 ratio
Standard Deviation 0.1
|
|
Fractional Flow Reserve (FFR) Value
Follow-up
|
0.73 ratio
Standard Deviation 0.1
|
0.75 ratio
Standard Deviation .01
|
SECONDARY outcome
Timeframe: Baseline and 6-8 weeks post interventionPercentage stenosis of vessel diameter in the analysis segment of nontarget lesions as measured by angiography that remained \>70%, after successful PCI of the target lesion.
Outcome measures
| Measure |
Standard of Care Lipid Therapy
n=43 Participants
standard-care lipid-lowering therapy: Zocor or Lipitor
standard of care lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.
Zocor, Lipitor \[any dose\] and Crestor \[less than 40mg\]
|
Aggressive Lipid Therapy
n=44 Participants
aggressive lipid therapy: Crestor
Aggressive lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.
|
|---|---|---|
|
Diameter Stenosis
Baseline
|
79.9 percentage of lesions
|
79.6 percentage of lesions
|
|
Diameter Stenosis
Follow-up
|
83 percentage of lesions
|
79.4 percentage of lesions
|
SECONDARY outcome
Timeframe: at 6-8 weeks after interventionCorrelation of yellow plaque index with post procedure CK-MB, Troponin-I release.
Outcome measures
| Measure |
Standard of Care Lipid Therapy
n=43 Participants
standard-care lipid-lowering therapy: Zocor or Lipitor
standard of care lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.
Zocor, Lipitor \[any dose\] and Crestor \[less than 40mg\]
|
Aggressive Lipid Therapy
n=44 Participants
aggressive lipid therapy: Crestor
Aggressive lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.
|
|---|---|---|
|
Post PCI Cardiac Enzymes
Troponin-I
|
0.4 ng/mL
Standard Deviation 1.0
|
0.3 ng/mL
Standard Deviation 5.1
|
|
Post PCI Cardiac Enzymes
CK-MB
|
5.1 ng/mL
Standard Deviation 9.0
|
3.7 ng/mL
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: at 6-8 weeks after interventionMACE defined as a combined clinical endpoint of death, MI (Q wave or non Q-wave with CK-MB \>3 times above the upper normal limit (48 U/L), urgent revascularization or stroke at 30 days and 1 year. Details reported in adverse events section.
Outcome measures
| Measure |
Standard of Care Lipid Therapy
n=43 Participants
standard-care lipid-lowering therapy: Zocor or Lipitor
standard of care lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.
Zocor, Lipitor \[any dose\] and Crestor \[less than 40mg\]
|
Aggressive Lipid Therapy
n=44 Participants
aggressive lipid therapy: Crestor
Aggressive lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.
|
|---|---|---|
|
Major Adverse Cardiac Events (MACE)
|
2 participants
|
3 participants
|
SECONDARY outcome
Timeframe: at baseline and at 6-8 weeks after interventionCorrelation of yellow plaque index with changes in levels of blood HsCRP as compared from baseline to 6-8 weeks after intervention
Outcome measures
| Measure |
Standard of Care Lipid Therapy
n=43 Participants
standard-care lipid-lowering therapy: Zocor or Lipitor
standard of care lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.
Zocor, Lipitor \[any dose\] and Crestor \[less than 40mg\]
|
Aggressive Lipid Therapy
n=44 Participants
aggressive lipid therapy: Crestor
Aggressive lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.
|
|---|---|---|
|
Blood Chemistry - HsCRP
Baseline
|
1.7 mg/l
Interval 0.7 to 3.4
|
1.7 mg/l
Interval 0.8 to 3.5
|
|
Blood Chemistry - HsCRP
Follow-Up
|
1.9 mg/l
Interval 0.7 to 4.7
|
1.2 mg/l
Interval 0.7 to 2.5
|
Adverse Events
Standard of Care Lipid Therapy
Aggressive Lipid Therapy
Serious adverse events
| Measure |
Standard of Care Lipid Therapy
n=43 participants at risk
standard-care lipid-lowering therapy: Zocor or Lipitor
|
Aggressive Lipid Therapy
n=44 participants at risk
aggressive lipid therapy: Crestor
|
|---|---|---|
|
Cardiac disorders
Hospitalization
|
4.7%
2/43
|
6.8%
3/44
|
Other adverse events
| Measure |
Standard of Care Lipid Therapy
n=43 participants at risk
standard-care lipid-lowering therapy: Zocor or Lipitor
|
Aggressive Lipid Therapy
n=44 participants at risk
aggressive lipid therapy: Crestor
|
|---|---|---|
|
Vascular disorders
Unplanned revascularization
|
4.7%
2/43 • Number of events 2
|
0.00%
0/44
|
|
Injury, poisoning and procedural complications
Periprocedural complications
|
2.3%
1/43 • Number of events 1
|
6.8%
3/44 • Number of events 3
|
|
Blood and lymphatic system disorders
Any bleeding
|
4.7%
2/43 • Number of events 2
|
0.00%
0/44
|
|
Hepatobiliary disorders
AST > 3x ULN
|
0.00%
0/43
|
0.00%
0/44
|
|
Hepatobiliary disorders
ALT > 3x ULN
|
0.00%
0/43
|
0.00%
0/44
|
|
Renal and urinary disorders
Creatine kinase-MB > 5x ULN
|
4.7%
2/43 • Number of events 2
|
2.3%
1/44 • Number of events 1
|
|
Renal and urinary disorders
Creatine kinase-MB >10x ULN
|
4.7%
2/43 • Number of events 2
|
0.00%
0/44
|
|
General disorders
Statin discontinuation
|
0.00%
0/43
|
0.00%
0/44
|
|
General disorders
Statin dose reduction
|
0.00%
0/43
|
6.8%
3/44 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place