- Change From Baseline in Atheroma, Vessel, and Lumen Volume to Month 18 [ Time Frame: Baseline to Month 18 ] [ Designated as safety issue: No ]
IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18
- Model Adjusted Change From Baseline in Atheroma Volume to Month 18 [ Time Frame: Baseline to Month 18 ] [ Designated as safety issue: No ]
IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.
- Model Adjusted Change From Baseline in Lumen Volume to Month 18 [ Time Frame: Baseline to Month 18 ] [ Designated as safety issue: No ]
IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.
- Model Adjusted Change From Baseline in Vessel Volume to Month 18 [ Time Frame: Baseline to Month 18 ] [ Designated as safety issue: No ]
IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.
- Change From Baseline in Atheroma, Vessel, and Lumen Area to Month 18 [ Time Frame: Baseline to Month 18 ] [ Designated as safety issue: No ]
IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18
- Model Adjusted Change From Baseline in Atheroma Area to Month 18 [ Time Frame: Baseline to Month 18 ] [ Designated as safety issue: No ]
IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.
- Model Adjusted Change From Baseline in Lumen Area to Month 18 [ Time Frame: Baseline to Month 18 ] [ Designated as safety issue: No ]
IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.
- Model Adjusted Change From Baseline in Vessel Area to Month 18 [ Time Frame: Baseline to Month 18 ] [ Designated as safety issue: No ]
IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.
- Change From Baseline in Normalized Atheroma Volume [ Time Frame: Baseline to Month 18 ] [ Designated as safety issue: No ]
IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Normalized atheroma volume is defined as mean atheroma area x median segment length in cohort.
- Model Adjusted Change From Baseline in Normalized Atheroma Volume [ Time Frame: Baseline to Month 18 ] [ Designated as safety issue: No ]
IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Normalized atheroma volume is defined as mean atheroma area x median segment length in cohort. Model Adjusted Change = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.
- Change in Atheroma Volume Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline [ Time Frame: Baseline to Month 18 ] [ Designated as safety issue: No ]
IVUS-derived endpoints measured within the same 10 mm segment of non-intervened coronary arteries with the greatest degree of atheroma volume at Baseline, from Baseline to Month 18, including the nominal change in atheroma volume and atheroma area
- Model Adjusted Change in Atheroma Volume Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline [ Time Frame: Baseline to Month 18 ] [ Designated as safety issue: No ]
IVUS-derived endpoints measured within the same 10 mm segment of non-intervened coronary arteries with the greatest degree of atheroma volume at Baseline, from Baseline to Month 18, including the nominal change in atheroma volume and atheroma area. Model Adjusted Change = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.
- Change in Atheroma Area Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline [ Time Frame: Baseline to Month 18 ] [ Designated as safety issue: No ]
IVUS-derived endpoints measured within the same 10 mm segment of non-intervened coronary arteries with the greatest degree of atheroma volume at Baseline, from Baseline to Month 18, including the nominal change in atheroma volume and atheroma area
- Model Adjusted Change in Atheroma Area Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline [ Time Frame: Baseline to Month 18 ] [ Designated as safety issue: No ]
IVUS-derived endpoints measured within the same 10 mm segment of non-intervened coronary arteries with the greatest degree of atheroma volume at Baseline, from Baseline to Month 18, including the nominal change in atheroma volume and atheroma area. Model Adjusted Change = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.
- Model Adjusted Change in Glycated Hemoglobin (HbA1c) From Baseline to Month 18 [ Time Frame: Baseline to Month 18 ] [ Designated as safety issue: No ]
From repeated measures analysis model: Change = Baseline + visit + sex + region + treatment + prior Oral Anti-Hyperglycemic Diabetic Medications(s) (OAD) + cardiac procedure + treatment x visit.
- Model Adjusted Change in Fasting Plasma Glucose (FPG) From Baseline to Month 18 [ Time Frame: Baseline to Month 18 ] [ Designated as safety issue: No ]
From repeated measures analysis model: Change = Baseline + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.
- Repeated Measures Analysis of Percent Change in hsCRP From Baseline to Month 18 [ Time Frame: Baseline to Month 18 ] [ Designated as safety issue: No ]
Changes in cardiovascular biomarkers from Baseline to Month 18, such as high sensitivity C-reactive protein (hsCRP) . Repeated measures analysis model: Log(value) - log(baseline) = log(baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.
- Repeated Measures Analysis of Percent Change in MMP 9 From Baseline to Month 18 [ Time Frame: Baseline to Month 18 ] [ Designated as safety issue: No ]
Changes in cardiovascular biomarkers from Baseline to Month 18, such as matrix metalloproteinase-9 (MMP-9). Repeated measures analysis model: Log(value) - log(baseline) = log(baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.
- Percent Change in Brain Natriuretic Peptide (BNP) From Baseline to Month 18 [ Time Frame: Baseline to Month 18 ] [ Designated as safety issue: No ]
It was measured as ratio to baseline as percentage change based on log-transformed data : 100 x (exp(Mean change on log scale) - 1)It was measured as ratio to baseline as percentage change based on log-transformed data : 100 x (exp(Mean change on log scale) - 1). Ratio to baseline as %change mean (%) was used as the estimation parameter for both groups.
- Model Adjusted Percent Change in Brain Natriuretic Peptide (BNP) From Baseline to Month 18 [ Time Frame: Baseline to Month 18 ] [ Designated as safety issue: No ]
It was measured as ratio to baseline as percentage change based on log-transformed data : 100 x (exp(Mean change on log scale) - 1). Model Adjusted change based on ANCOVA: Log(value) - log(Baseline) = log(Baseline) + sex + region + treatment + prior OAD + cardiac procedure.
- Percent Change From Baseline to Month 18 in Total Cholesterol (TC) [ Time Frame: Baseline to Month 18 ] [ Designated as safety issue: No ]
Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.
- Percent Change From Baseline to Month 18 in High Density Lipoprotein Cholesterol (HDL-c) [ Time Frame: Baseline to Month 18 ] [ Designated as safety issue: No ]
Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.
- Percent Change From Baseline to Month 18 in HDL-2 [ Time Frame: Baseline to Month 18 ] [ Designated as safety issue: No ]
Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.
- Percent Change From Baseline to Month 18 in HDL-3 [ Time Frame: Baseline to Month 18 ] [ Designated as safety issue: No ]
Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.
- Percent Change From Baseline to Month 18 in Low Density Lipoprotein Cholesterol (LDL-c) [ Time Frame: Baseline to Month 18 ] [ Designated as safety issue: No ]
Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.
- Percent Change From Baseline to Month 18 in Triglycerides (TG) [ Time Frame: Baseline to Month 18 ] [ Designated as safety issue: No ]
Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.
- Percent Change From Baseline to Month 18 in Free Fatty Acids (FFA) [ Time Frame: Baseline to Month 18 ] [ Designated as safety issue: No ]
Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.
- Percent Change From Baseline to Month 18 in Apoprotein B (apoB) [ Time Frame: Baseline to Month 18 ] [ Designated as safety issue: No ]
Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.
- Change From Baseline to Month 18 in LDL-c Peak Particle Density Measured by LDL Relative Flotation [ Time Frame: Baseline to Month 18 ] [ Designated as safety issue: No ]
From repeated measures analysis model: Change = baseline + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.
- Change From Baseline to Month 18 in Total Cholesterol/HDL-c Ratio [ Time Frame: Baseline to Month 18 ] [ Designated as safety issue: No ]
From repeated measures analysis model: Change = baseline + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.
- Change From Baseline to Month 18 in LDL-c/HDL-c Ratio [ Time Frame: Baseline to Month 18 ] [ Designated as safety issue: No ]
From repeated measures analysis model: Change = baseline + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.
- Number of Participants With the Indicated Treatment Emergent Major Cardiovascular Events (MACE) for All-cause Death, Non-fatal MI, Non-fatal Stroke, Coronary Revascularization, or Hospitalization for Recurrent Myocardial Ischemia (MACE Composite 1) [ Time Frame: Baseline to Month 21 ] [ Designated as safety issue: No ]
This was 1 of 2 MACE composite endpoints and was a secondary efficacy endpoint.
- Number of Participants With the Indicated Treatment Emergent Major Cardiovascular Events (MACE) for Cardiovascular Death, Nonfatal MI, or Nonfatal Stroke (MACE Composite 2) [ Time Frame: Baseline to Month 21 ] [ Designated as safety issue: No ]
This was 1 of 2 MACE composite endpoints and was a secondary efficacy endpoint.
- Number of Other Cardiovascular Events [ Time Frame: Baseline to Month 21 ] [ Designated as safety issue: No ]
This was one of the secondary endpoints of the study.