Acute Coronary Syndrome
Conditions
Keywords
Hyperlipidemia, Atherosclerotic Cardiovascular Disease, Hypercholesterolemia, Lipid lowering therapies
Brief summary
The purpose of this study is to study the effectiveness of implementation of a systematic LDL-C management pathway including treatment with inclisiran in participants who have experienced a recent acute coronary syndrome (ACS) and have an increased LDL-cholesterol (≥70 mg/dL) despite being treated with a statin drug.
Detailed description
This was a randomized, parallel-group, open-label, multicenter, 1-year (30-day Screening Period and 330-day Treatment Period) study comparing an LDL-C management strategy including inclisiran + usual care to usual care alone. Approximately 384 participants were planned to be randomized 1:1 to aggressive LDL-C management with inclisiran + usual care (intervention arm) (3 inclisiran doses) or usual care (control arm). Usual care could have included addition of ezetimibe, bempedoic acid, PCSK9-inhibiting monoclonal antibodies, and/or commercially available inclisiran
Interventions
DRUGInclisiran
Inclisiran sodium 300 mg / 1.5 ml (equivalent to 284 mg of inclisiran)
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Recent Acute Coronary Syndrome (in-patient/out-patient) within 5 weeks of screening * Serum LDL-C ≥70 mg/dL or non-HDL-C ≥100 mg/dL * Fasting triglycerides \<4.52 mmol/L (\<400 mg/dL) at screening * Calculated glomerular filtration rate \>20 mL/min by estimated glomerular filtration rate (eGFR) * Participants are required to be discharged on statin therapy, or have documented statin intolerance, as determined by the investigator, following hospitalization for an ACS. Statin intolerant participants are eligible if they had intolerable side effects on at least 2 different statins, including one at the lowest standard dose
Exclusion criteria
* New York Heart Association (NYHA) class IIIb or IV heart failure or last known left ventricular ejection fraction \<25%. * Significant cardiac arrhythmia within 3 months prior to randomization that is not controlled by medication or via ablation at the time of screening. * Severe concomitant non-cardiovascular disease that carries the risk of reducing life expectancy to less than 2 years. * Treatment with other investigational products or devices within 30 days or five half˗lives of the screening visit, whichever is longer. * Planned use of other investigational products or devices during the course of the study. * Treatment with monoclonal antibodies directed towards PCSK9 within 90 days of screening. * Recurrent ACS event within 2 weeks prior to randomization. * Coronary angiography and revascularization procedure (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) surgery) performed within 2 weeks prior to the randomization visit or planned after randomization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline to Day 330 in LDL-C | Baseline and Day 330 | Percent change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Day 330 |
| Achievement of LDL-C < 70 mg/dL at Day 330 | Day 330 | Percentage of participants achieving Low-Density Lipoprotein Cholesterol (LDL-C) \< 70 mg/dL at Day 330 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Absolute Change From Baseline in LDL-C Levels | Baseline, From Day 90 to Day 330 | Average absolute change from baseline in low-density lipoprotein cholesterol (LDL-C) levels to each post-baseline visit |
| Achieving ≥50% Reduction From Baseline in LDL-C | Baseline, Day 330 | Percentage of participants achieving ≥50% reduction from baseline in low-density lipoprotein cholesterol (LDL-C) at Day 330 |
| Achieving LDL-C < 100 mg/dL and LDL-C < 55 mg/dL | Day 330 | Percentage of participants achieving low-density lipoprotein cholesterol (LDL-C) \<100 mg/dL (among the subset of participants with baseline LDL-C \>= 100 mg/dL) and LDL-C \< 55 mg/dL at Day 330 |
| Percent Change in Lipids and Other Lipoproteins From Baseline to Day 330 | Baseline and Day 330 | Percent change in apolipoprotein B, very-low-density lipoprotein (VLDL), non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol, lipoprotein(a) (Lp\[a\]), HDL-C and triglycerides from baseline to Day 330 |
| Absolute Change From Baseline in LDL-C | Baseline, Day 90, Day 270 and Day 330 | Absolute change from baseline in low-density lipoprotein cholesterol (LDL-C) by visit |
| Absolute Change in Lp[a] From Baseline to Day 330 | Baseline and Day 330 | Absolute change in lipoprotein(a) (Lp\[a\]) from baseline to Day 330 |
| Intensity of Lipid Lowering Therapy | Baseline and Day 330 | Percentage of participants by intensity of lipid lowering therapy (dose decrease, increase or no change) |
| Proportion of Days Covered | Baseline through last date of participation, up to 330 Days | Total number of days on either statin, ezetimibe, or PCSK9 inhibiting monoclonal antibody therapies divided by total number of study days. If a participant did not take any of the 3 medications, then the total number of days was assumed to be zero. |
| Discontinuation of Statin Therapy | Baseline and Day 330 | Percentage of participants discontinuing statin therapy. Discontinuation of statin therapy was defined as no statin use ≥ 30 days before the end-of-study visit. Participants for whom it could not be ascertained that they were on statin therapy at the end of study or who discontinued from the study early were assumed to have discontinued statin therapy. |
| Absolute Change in Lipids and Other Lipoproteins From Baseline to Day 330 | Baseline and Day 330 | Absolute change in apolipoprotein B, very-low-density lipoprotein (VLDL), non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol, HDL-C and triglycerides from baseline to Day 330 |
| Average Percent Change From Baseline in LDL-C Levels | Baseline, from Day 90 to Day 330 | Average percent change from baseline in low-density lipoprotein cholesterol (LDL-C) levels to each post-baseline visit |
Countries
United States
Participant flow
Recruitment details
This study was conducted at 87 study centers. Of the 201 participants randomized to inclisiran + usual care, 1 participant was randomized erroneously and did not receive inclisiran. Of the 199 participants randomized to usual care, 3 participants received commercially available inclisiran as part of their concomitant medications.
Participants by arm
| Arm | Count |
|---|---|
| Inclisiran With Usual Care Inclisiran sodium 300 mg / 1.5 ml (equivalent to 284 mg of inclisiran) + usual care | 201 |
| Usual Care Usual Care Alone | 199 |
| Total | 400 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Death | 0 | 2 |
| Overall Study | Lost to Follow-up | 13 | 9 |
| Overall Study | Missing | 1 | 0 |
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Protocol deviation | 2 | 1 |
| Overall Study | Subject decision | 1 | 8 |
| Overall Study | Withdrew consent | 0 | 4 |
Baseline characteristics
| Characteristic | Inclisiran With Usual Care | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 60.8 years STANDARD_DEVIATION 10.9 | 60.2 years STANDARD_DEVIATION 11.69 | 60.5 years STANDARD_DEVIATION 11.29 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 6 Participants | 3 Participants | 9 Participants |
| Race/Ethnicity, Customized Black or African American | 25 Participants | 24 Participants | 49 Participants |
| Race/Ethnicity, Customized Multiple | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Unknown | 2 Participants | 4 Participants | 6 Participants |
| Race/Ethnicity, Customized White | 166 Participants | 167 Participants | 333 Participants |
| Sex: Female, Male Female | 63 Participants | 53 Participants | 116 Participants |
| Sex: Female, Male Male | 138 Participants | 146 Participants | 284 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 203 | 2 / 197 |
| other Total, other adverse events | 52 / 203 | 35 / 197 |
| serious Total, serious adverse events | 32 / 203 | 34 / 197 |
Outcome results
Primary
Achievement of LDL-C < 70 mg/dL at Day 330
Percentage of participants achieving Low-Density Lipoprotein Cholesterol (LDL-C) \< 70 mg/dL at Day 330
Time frame: Day 330
Population: Full Analysis Set (FAS) comprised all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Inclisiran With Usual Care | Achievement of LDL-C < 70 mg/dL at Day 330 | 66.7 Percentage of participants |
| Usual Care | Achievement of LDL-C < 70 mg/dL at Day 330 | 28.1 Percentage of participants |
p-value: <0.00197.5% CI: [3.29, 8.91]Regression, Logistic
Primary
Percent Change From Baseline to Day 330 in LDL-C
Percent change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Day 330
Time frame: Baseline and Day 330
Population: Full Analysis Set (FAS) comprised all randomized participants. The number of participants analyzed corresponds to the number of subjects who had LDL-C values at baseline and Day 330.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Inclisiran With Usual Care | Percent Change From Baseline to Day 330 in LDL-C | -45.6 Percent change in LDL-C |
| Usual Care | Percent Change From Baseline to Day 330 in LDL-C | 1.4 Percent change in LDL-C |
p-value: <0.00197.5% CI: [-55.4, -38.5]Mixed Models Analysis
Secondary
Absolute Change From Baseline in LDL-C
Absolute change from baseline in low-density lipoprotein cholesterol (LDL-C) by visit
Time frame: Baseline, Day 90, Day 270 and Day 330
Population: Full Analysis Set (FAS) comprised all randomized participants. The number of participants analyzed corresponds to the number of subjects who had LDL-C values at baseline and Day 90, Day 270 and Day 330 respectively.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Inclisiran With Usual Care | Absolute Change From Baseline in LDL-C | Day 90 | -44.2 mg/dL |
| Inclisiran With Usual Care | Absolute Change From Baseline in LDL-C | Day 270 | -34.6 mg/dL |
| Inclisiran With Usual Care | Absolute Change From Baseline in LDL-C | Day 330 | -41.2 mg/dL |
| Usual Care | Absolute Change From Baseline in LDL-C | Day 90 | -2.2 mg/dL |
| Usual Care | Absolute Change From Baseline in LDL-C | Day 270 | -3.8 mg/dL |
| Usual Care | Absolute Change From Baseline in LDL-C | Day 330 | -3.5 mg/dL |
Comparison: Day 90p-value: <0.00195% CI: [-47.3, -36.7]Mixed Models Analysis
Comparison: Day 270p-value: <0.00195% CI: [-37.4, -24.3]Mixed Models Analysis
Comparison: Day 330p-value: <0.00195% CI: [-44.5, -31]Mixed Models Analysis
Secondary
Absolute Change in Lipids and Other Lipoproteins From Baseline to Day 330
Absolute change in apolipoprotein B, very-low-density lipoprotein (VLDL), non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol, HDL-C and triglycerides from baseline to Day 330
Time frame: Baseline and Day 330
Population: Full Analysis Set (FAS) comprised all randomized participants. The number of participants analyzed corresponds to the number of subjects who had values at baseline and Day 330.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Inclisiran With Usual Care | Absolute Change in Lipids and Other Lipoproteins From Baseline to Day 330 | apolipoprotein B | -31.0 mg/dL |
| Inclisiran With Usual Care | Absolute Change in Lipids and Other Lipoproteins From Baseline to Day 330 | VLDL Cholesterol | -0.4 mg/dL |
| Inclisiran With Usual Care | Absolute Change in Lipids and Other Lipoproteins From Baseline to Day 330 | non-HDL-Cholesterol | -41.4 mg/dL |
| Inclisiran With Usual Care | Absolute Change in Lipids and Other Lipoproteins From Baseline to Day 330 | total Cholesterol | -35.2 mg/dL |
| Inclisiran With Usual Care | Absolute Change in Lipids and Other Lipoproteins From Baseline to Day 330 | HDL-Cholesterol | 5.7 mg/dL |
| Inclisiran With Usual Care | Absolute Change in Lipids and Other Lipoproteins From Baseline to Day 330 | triglycerides | 1.1 mg/dL |
| Usual Care | Absolute Change in Lipids and Other Lipoproteins From Baseline to Day 330 | HDL-Cholesterol | 3.8 mg/dL |
| Usual Care | Absolute Change in Lipids and Other Lipoproteins From Baseline to Day 330 | apolipoprotein B | -2.6 mg/dL |
| Usual Care | Absolute Change in Lipids and Other Lipoproteins From Baseline to Day 330 | total Cholesterol | 2.5 mg/dL |
| Usual Care | Absolute Change in Lipids and Other Lipoproteins From Baseline to Day 330 | VLDL Cholesterol | 1.8 mg/dL |
| Usual Care | Absolute Change in Lipids and Other Lipoproteins From Baseline to Day 330 | triglycerides | 9.8 mg/dL |
| Usual Care | Absolute Change in Lipids and Other Lipoproteins From Baseline to Day 330 | non-HDL-Cholesterol | -1.3 mg/dL |
Comparison: Apolipoprotein Bp-value: <0.00195% CI: [-33, -23.9]Mixed Models Analysis
Comparison: VLDL Cholesterolp-value: 0.07895% CI: [-4.5, 0.2]Mixed Models Analysis
Comparison: Non-HDL Cholesterolp-value: <0.00195% CI: [-47.5, -32.8]Mixed Models Analysis
Comparison: Total Cholesterolp-value: <0.00195% CI: [-45.3, -30.2]Mixed Models Analysis
Comparison: HDL Cholesterolp-value: 0.06595% CI: [-0.1, 3.8]Mixed Models Analysis
Comparison: Triglyceridesp-value: 0.22295% CI: [-22.8, 5.3]Mixed Models Analysis
Secondary
Absolute Change in Lp[a] From Baseline to Day 330
Absolute change in lipoprotein(a) (Lp\[a\]) from baseline to Day 330
Time frame: Baseline and Day 330
Population: Full Analysis Set (FAS) comprised all randomized participants. The number of participants analyzed corresponds to the number of subjects who had values at baseline and Day 330.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Inclisiran With Usual Care | Absolute Change in Lp[a] From Baseline to Day 330 | -19.3 nmol/L |
| Usual Care | Absolute Change in Lp[a] From Baseline to Day 330 | -5.3 nmol/L |
Comparison: Lipoprotein(a)p-value: 0.00595% CI: [-23.8, -4.2]Mixed Models Analysis
Secondary
Achieving ≥50% Reduction From Baseline in LDL-C
Percentage of participants achieving ≥50% reduction from baseline in low-density lipoprotein cholesterol (LDL-C) at Day 330
Time frame: Baseline, Day 330
Population: Full Analysis Set (FAS) comprised all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Inclisiran With Usual Care | Achieving ≥50% Reduction From Baseline in LDL-C | 45.3 Percentage of participants |
| Usual Care | Achieving ≥50% Reduction From Baseline in LDL-C | 6.5 Percentage of participants |
p-value: <0.00195% CI: [6.33, 22.25]Regression, Logistic
Secondary
Achieving LDL-C < 100 mg/dL and LDL-C < 55 mg/dL
Percentage of participants achieving low-density lipoprotein cholesterol (LDL-C) \<100 mg/dL (among the subset of participants with baseline LDL-C \>= 100 mg/dL) and LDL-C \< 55 mg/dL at Day 330
Time frame: Day 330
Population: Full Analysis Set (FAS) comprised all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Inclisiran With Usual Care | Achieving LDL-C < 100 mg/dL and LDL-C < 55 mg/dL | Achieving LDL-C < 100 mg/dL | 75.8 Percentage of participants |
| Inclisiran With Usual Care | Achieving LDL-C < 100 mg/dL and LDL-C < 55 mg/dL | Achieving LDL-C < 55 mg/dL | 54.2 Percentage of participants |
| Usual Care | Achieving LDL-C < 100 mg/dL and LDL-C < 55 mg/dL | Achieving LDL-C < 100 mg/dL | 40.4 Percentage of participants |
| Usual Care | Achieving LDL-C < 100 mg/dL and LDL-C < 55 mg/dL | Achieving LDL-C < 55 mg/dL | 13.6 Percentage of participants |
Comparison: Achieving LDL-C \< 100 mg/dLp-value: <0.00195% CI: [1.92, 9.99]Regression, Logistic
Comparison: Achieving LDL-C \< 55 mg/dLp-value: <0.00195% CI: [4.97, 13.65]Regression, Logistic
Secondary
Average Absolute Change From Baseline in LDL-C Levels
Average absolute change from baseline in low-density lipoprotein cholesterol (LDL-C) levels to each post-baseline visit
Time frame: Baseline, From Day 90 to Day 330
Population: Full Analysis Set (FAS) comprised all randomized participants. The number of participants analyzed corresponds to the number of subjects who had at least one LDL-C change from baseline value available.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Inclisiran With Usual Care | Average Absolute Change From Baseline in LDL-C Levels | -40.0 mg/dL |
| Usual Care | Average Absolute Change From Baseline in LDL-C Levels | -2.7 mg/dL |
p-value: <0.00195% CI: [-42.4, -32.2]ANCOVA
Secondary
Average Percent Change From Baseline in LDL-C Levels
Average percent change from baseline in low-density lipoprotein cholesterol (LDL-C) levels to each post-baseline visit
Time frame: Baseline, from Day 90 to Day 330
Population: Full Analysis Set (FAS) comprised all randomized participants. The number of participants analyzed corresponds to the number of subjects who had at least one LDL-C change from baseline value available.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Inclisiran With Usual Care | Average Percent Change From Baseline in LDL-C Levels | -44.3 Average percent change in LDL-C |
| Usual Care | Average Percent Change From Baseline in LDL-C Levels | 2.4 Average percent change in LDL-C |
p-value: <0.00195% CI: [-52.7, -40.8]ANCOVA
Secondary
Discontinuation of Statin Therapy
Percentage of participants discontinuing statin therapy. Discontinuation of statin therapy was defined as no statin use ≥ 30 days before the end-of-study visit. Participants for whom it could not be ascertained that they were on statin therapy at the end of study or who discontinued from the study early were assumed to have discontinued statin therapy.
Time frame: Baseline and Day 330
Population: Full Analysis Set (FAS) comprised all randomized participants. Participants with Medical History of Statin Intolerance were excluded.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Inclisiran With Usual Care | Discontinuation of Statin Therapy | 14.5 Percentage of participants |
| Usual Care | Discontinuation of Statin Therapy | 18.0 Percentage of participants |
p-value: 0.34695% CI: [0.43, 1.35]Regression, Logistic
Secondary
Intensity of Lipid Lowering Therapy
Percentage of participants by intensity of lipid lowering therapy (dose decrease, increase or no change)
Time frame: Baseline and Day 330
Population: Full Analysis Set (FAS) comprised all randomized participants. The number of participants analyzed corresponds to the number of subjects who had a record for Day 330 study visit date.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Inclisiran With Usual Care | Intensity of Lipid Lowering Therapy | Decrease in statin intensity | 9.8 Percentage of participants |
| Inclisiran With Usual Care | Intensity of Lipid Lowering Therapy | No change in statin intensity | 89.1 Percentage of participants |
| Inclisiran With Usual Care | Intensity of Lipid Lowering Therapy | Increase in statin intensity | 1.1 Percentage of participants |
| Usual Care | Intensity of Lipid Lowering Therapy | Decrease in statin intensity | 4.6 Percentage of participants |
| Usual Care | Intensity of Lipid Lowering Therapy | No change in statin intensity | 92.5 Percentage of participants |
| Usual Care | Intensity of Lipid Lowering Therapy | Increase in statin intensity | 2.9 Percentage of participants |
p-value: 0.03195% CI: [0.2, 0.93]proportional odds model
Secondary
Percent Change in Lipids and Other Lipoproteins From Baseline to Day 330
Percent change in apolipoprotein B, very-low-density lipoprotein (VLDL), non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol, lipoprotein(a) (Lp\[a\]), HDL-C and triglycerides from baseline to Day 330
Time frame: Baseline and Day 330
Population: Full Analysis Set (FAS) comprised all randomized participants. The number of participants analyzed corresponds to the number of subjects who had values at baseline and Day 330.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Inclisiran With Usual Care | Percent Change in Lipids and Other Lipoproteins From Baseline to Day 330 | non-HDL-Cholesterol | -35.2 Percent change |
| Inclisiran With Usual Care | Percent Change in Lipids and Other Lipoproteins From Baseline to Day 330 | Lp[a] | -10.4 Percent change |
| Inclisiran With Usual Care | Percent Change in Lipids and Other Lipoproteins From Baseline to Day 330 | VLDL Cholesterol | 5.7 Percent change |
| Inclisiran With Usual Care | Percent Change in Lipids and Other Lipoproteins From Baseline to Day 330 | HDL-Cholesterol | 14.0 Percent change |
| Inclisiran With Usual Care | Percent Change in Lipids and Other Lipoproteins From Baseline to Day 330 | Total Cholesterol | -21.4 Percent change |
| Inclisiran With Usual Care | Percent Change in Lipids and Other Lipoproteins From Baseline to Day 330 | triglycerides | 7.3 Percent change |
| Inclisiran With Usual Care | Percent Change in Lipids and Other Lipoproteins From Baseline to Day 330 | apolipoprotein B | -35.5 Percent change |
| Usual Care | Percent Change in Lipids and Other Lipoproteins From Baseline to Day 330 | triglycerides | 12.3 Percent change |
| Usual Care | Percent Change in Lipids and Other Lipoproteins From Baseline to Day 330 | apolipoprotein B | 2.0 Percent change |
| Usual Care | Percent Change in Lipids and Other Lipoproteins From Baseline to Day 330 | VLDL Cholesterol | 12.1 Percent change |
| Usual Care | Percent Change in Lipids and Other Lipoproteins From Baseline to Day 330 | non-HDL-Cholesterol | 2.5 Percent change |
| Usual Care | Percent Change in Lipids and Other Lipoproteins From Baseline to Day 330 | Total Cholesterol | 4.1 Percent change |
| Usual Care | Percent Change in Lipids and Other Lipoproteins From Baseline to Day 330 | Lp[a] | 5.9 Percent change |
| Usual Care | Percent Change in Lipids and Other Lipoproteins From Baseline to Day 330 | HDL-Cholesterol | 10.6 Percent change |
Comparison: Apolipoprotein Bp-value: <0.00195% CI: [-44.8, -30.3]Mixed Models Analysis
Comparison: VLDL Cholesterolp-value: 0.18895% CI: [-16, 3.1]Mixed Models Analysis
Comparison: Non-HDL Cholesterolp-value: <0.00195% CI: [-44, -31.4]Mixed Models Analysis
Comparison: Total Cholesterolp-value: <0.00195% CI: [-30.2, -20.7]Mixed Models Analysis
Comparison: Lipoprotein(a)p-value: 0.14595% CI: [-38.4, 5.7]Mixed Models Analysis
Comparison: HDL Cholesterolp-value: 0.14195% CI: [-1.2, 8.1]Mixed Models Analysis
Comparison: Triglyceridesp-value: 0.33995% CI: [-15.2, 5.3]Mixed Models Analysis
Secondary
Proportion of Days Covered
Total number of days on either statin, ezetimibe, or PCSK9 inhibiting monoclonal antibody therapies divided by total number of study days. If a participant did not take any of the 3 medications, then the total number of days was assumed to be zero.
Time frame: Baseline through last date of participation, up to 330 Days
Population: Full Analysis Set (FAS) comprised all randomized participants.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Inclisiran With Usual Care | Proportion of Days Covered | 0.926 Proportion of days |
| Usual Care | Proportion of Days Covered | 0.965 Proportion of days |
p-value: 0.04395% CI: [-0.077, -0.001]ANCOVA