Trial Outcomes & Findings for Treatment of High and Very High riSk Dyslipidemic pAtients for the PreveNTion of CardiOvasculaR Events (NCT NCT04271280)
NCT ID: NCT04271280
Last Updated: 2024-02-20
Results Overview
Blood plasma samples were used to assess LDL-C levels.
Recruitment status
COMPLETED
Target enrollment
9559 participants
Primary outcome timeframe
Baseline up to 12 months post-enrollment
Results posted on
2024-02-20
Participant Flow
A total of 9559 participants were documented in this study (all-documented patients set; APS). Of these 9559 participants, 11 failed screening and 5 were not included due to end of enrollment. A total of 9543 participants were included in the Baseline Analysis Set (BAS) at 580 centers in 14 countries. Of these 9543 participants, a total of 9136 were included in the Full Analysis Set (FAS).
Participant milestones
| Measure |
High Risk and Very High Risk Dyslipidemic Participants
Participants were classified as High and Very High Risk (as assessed by the Framingham risk score for High Risk participants and the SMART score for Very High Risk participants) as well as if previously or newly diagnosed.
|
|---|---|
|
Overall Study
STARTED
|
9559
|
|
Overall Study
Baseline Analysis Set
|
9543
|
|
Overall Study
Full Analysis Set
|
9136
|
|
Overall Study
COMPLETED
|
8954
|
|
Overall Study
NOT COMPLETED
|
605
|
Reasons for withdrawal
| Measure |
High Risk and Very High Risk Dyslipidemic Participants
Participants were classified as High and Very High Risk (as assessed by the Framingham risk score for High Risk participants and the SMART score for Very High Risk participants) as well as if previously or newly diagnosed.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
300
|
|
Overall Study
Death
|
153
|
|
Overall Study
Withdrawal of consent by patient
|
59
|
|
Overall Study
Other
|
51
|
|
Overall Study
No end of study information
|
42
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
High Risk and Very High Risk Dyslipidemic Participants
n=9543 Participants
Participants were classified as High and Very High Risk (as assessed by the Framingham risk score for High Risk participants and the SMART score for Very High Risk participants) as well as if previously or newly diagnosed.
|
|---|---|
|
Age, Continuous
|
65.4 years
STANDARD_DEVIATION 10.9 • n=9543 Participants
|
|
Sex: Female, Male
Female
|
2618 Participants
n=9543 Participants
|
|
Sex: Female, Male
Male
|
6925 Participants
n=9543 Participants
|
|
Region of Enrollment
United Kingdom
|
658 participants
n=9543 Participants
|
|
Region of Enrollment
Portugal
|
120 participants
n=9543 Participants
|
|
Region of Enrollment
Switzerland
|
169 participants
n=9543 Participants
|
|
Region of Enrollment
Spain
|
1043 participants
n=9543 Participants
|
|
Region of Enrollment
Austria
|
306 participants
n=9543 Participants
|
|
Region of Enrollment
Netherlands
|
535 participants
n=9543 Participants
|
|
Region of Enrollment
Sweden
|
192 participants
n=9543 Participants
|
|
Region of Enrollment
Belgium
|
530 participants
n=9543 Participants
|
|
Region of Enrollment
Ireland
|
100 participants
n=9543 Participants
|
|
Region of Enrollment
Finland
|
338 participants
n=9543 Participants
|
|
Region of Enrollment
Denmark
|
319 participants
n=9543 Participants
|
|
Region of Enrollment
Italy
|
2089 participants
n=9543 Participants
|
|
Region of Enrollment
France
|
855 participants
n=9543 Participants
|
|
Region of Enrollment
Germany
|
2289 participants
n=9543 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 12 months post-enrollmentPopulation: Low Density Lipid-Cholesterol (LDL-C) levels were assessed in participants with available data in the Full Analysis Set.
Blood plasma samples were used to assess LDL-C levels.
Outcome measures
| Measure |
High Risk and Very High Risk Dyslipidemic Participants
n=8537 Participants
Participants were classified as High and Very High Risk (as assessed by the Framingham risk score for High Risk participants and the SMART score for Very High Risk participants) as well as if previously or newly diagnosed.
|
|---|---|
|
Mean Low Density Lipid-Cholesterol (LDL-C) Levels in High and Very High Risk Cardiovascular Participants
Baseline
|
2.40 mmol/L
Standard Deviation 1.20
|
|
Mean Low Density Lipid-Cholesterol (LDL-C) Levels in High and Very High Risk Cardiovascular Participants
1 Year
|
1.99 mmol/L
Standard Deviation 0.94
|
PRIMARY outcome
Timeframe: Baseline up to 12 months post-enrollmentPopulation: Treatment modalities were assessed among participants requiring LMTs with available data in the Full Analysis Set.
Clinical events were assessed based on information captured in patient files/medical records.
Outcome measures
| Measure |
High Risk and Very High Risk Dyslipidemic Participants
n=9136 Participants
Participants were classified as High and Very High Risk (as assessed by the Framingham risk score for High Risk participants and the SMART score for Very High Risk participants) as well as if previously or newly diagnosed.
|
|---|---|
|
Number of Participants Utilizing Any Treatment Modality to Manage Plasma Levels of Low Density Lipid-Cholesterol (LDL-C) in High and Very High Risk Participants Requiring Lipid Modifying Therapies (LMTs)
Received any ezetimibe
|
2538 Participants
|
|
Number of Participants Utilizing Any Treatment Modality to Manage Plasma Levels of Low Density Lipid-Cholesterol (LDL-C) in High and Very High Risk Participants Requiring Lipid Modifying Therapies (LMTs)
Received any other LMT
|
2128 Participants
|
|
Number of Participants Utilizing Any Treatment Modality to Manage Plasma Levels of Low Density Lipid-Cholesterol (LDL-C) in High and Very High Risk Participants Requiring Lipid Modifying Therapies (LMTs)
Received any LMT
|
8931 Participants
|
|
Number of Participants Utilizing Any Treatment Modality to Manage Plasma Levels of Low Density Lipid-Cholesterol (LDL-C) in High and Very High Risk Participants Requiring Lipid Modifying Therapies (LMTs)
Received any statin
|
7680 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 12 months post-enrollmentPopulation: Mean ASCVD-modifying cholesterol levels were assessed in participants with available data in the Full Analysis Set.
Blood plasma samples were used to assess ASCVD-modifying cholesterol fragment levels.
Outcome measures
| Measure |
High Risk and Very High Risk Dyslipidemic Participants
n=8531 Participants
Participants were classified as High and Very High Risk (as assessed by the Framingham risk score for High Risk participants and the SMART score for Very High Risk participants) as well as if previously or newly diagnosed.
|
|---|---|
|
Mean Atherosclerotic Cardiovascular Disease (ASCVD)-Modifying Cholesterol Fragment Levels in High Risk and Very High Risk Dyslipidemic Participants
Baseline: HDL-C
|
1.27 mmol/L
Standard Deviation 0.40
|
|
Mean Atherosclerotic Cardiovascular Disease (ASCVD)-Modifying Cholesterol Fragment Levels in High Risk and Very High Risk Dyslipidemic Participants
1 Year: HDL-C
|
1.28 mmol/L
Standard Deviation 0.39
|
|
Mean Atherosclerotic Cardiovascular Disease (ASCVD)-Modifying Cholesterol Fragment Levels in High Risk and Very High Risk Dyslipidemic Participants
Baseline: Non-HDL-C
|
3.02 mmol/L
Standard Deviation 1.35
|
|
Mean Atherosclerotic Cardiovascular Disease (ASCVD)-Modifying Cholesterol Fragment Levels in High Risk and Very High Risk Dyslipidemic Participants
1 Year: Non-HDL-C
|
2.58 mmol/L
Standard Deviation 1.06
|
|
Mean Atherosclerotic Cardiovascular Disease (ASCVD)-Modifying Cholesterol Fragment Levels in High Risk and Very High Risk Dyslipidemic Participants
Baseline: Total Cholesterol
|
4.31 mmol/L
Standard Deviation 1.40
|
|
Mean Atherosclerotic Cardiovascular Disease (ASCVD)-Modifying Cholesterol Fragment Levels in High Risk and Very High Risk Dyslipidemic Participants
1 Year: Triglycerides
|
1.56 mmol/L
Standard Deviation 1.04
|
|
Mean Atherosclerotic Cardiovascular Disease (ASCVD)-Modifying Cholesterol Fragment Levels in High Risk and Very High Risk Dyslipidemic Participants
1 Year: Total Cholesterol
|
3.86 mmol/L
Standard Deviation 1.13
|
|
Mean Atherosclerotic Cardiovascular Disease (ASCVD)-Modifying Cholesterol Fragment Levels in High Risk and Very High Risk Dyslipidemic Participants
Baseline: Triglycerides
|
1.70 mmol/L
Standard Deviation 1.17
|
SECONDARY outcome
Timeframe: Baseline up to 12 months post-enrollmentPopulation: Mean apolipoprotein B levels were assessed in participants with available data in the Full Analysis Set.
Blood plasma samples were used to assess Apolipoprotein B levels.
Outcome measures
| Measure |
High Risk and Very High Risk Dyslipidemic Participants
n=492 Participants
Participants were classified as High and Very High Risk (as assessed by the Framingham risk score for High Risk participants and the SMART score for Very High Risk participants) as well as if previously or newly diagnosed.
|
|---|---|
|
Mean Apolipoprotein B Levels in High Risk and Very High Risk Dyslipidemic Participants
Baseline
|
0.92 g/L
Standard Deviation 0.39
|
|
Mean Apolipoprotein B Levels in High Risk and Very High Risk Dyslipidemic Participants
1 Year
|
0.80 g/L
Standard Deviation 0.34
|
SECONDARY outcome
Timeframe: Baseline up to 12 months post-enrollmentPopulation: Mean lipid protein A levels were assessed in participants with available data in the Full Analysis Set.
Blood plasma samples were used to assess lipid Protein A levels.
Outcome measures
| Measure |
High Risk and Very High Risk Dyslipidemic Participants
n=882 Participants
Participants were classified as High and Very High Risk (as assessed by the Framingham risk score for High Risk participants and the SMART score for Very High Risk participants) as well as if previously or newly diagnosed.
|
|---|---|
|
Mean Lipid Protein A Levels in High Risk and Very High Risk Dyslipidemic Participants
Baseline
|
47.97 mg/dL
Standard Deviation 53.87
|
|
Mean Lipid Protein A Levels in High Risk and Very High Risk Dyslipidemic Participants
1 Year
|
51.24 mg/dL
Standard Deviation 53.47
|
SECONDARY outcome
Timeframe: Baseline up to 12 months post-enrollmentPopulation: Mean hsCRP levels were assessed in participants with available data in the Full Analysis Set.
Blood plasma samples were used to assess hsCRP levels.
Outcome measures
| Measure |
High Risk and Very High Risk Dyslipidemic Participants
n=1818 Participants
Participants were classified as High and Very High Risk (as assessed by the Framingham risk score for High Risk participants and the SMART score for Very High Risk participants) as well as if previously or newly diagnosed.
|
|---|---|
|
Mean Inflammatory High-Sensitive C-Reactive Protein (hsCRP) in High Risk and Very High Risk Dyslipidemic Participants
Baseline
|
6.90 mg/L
Standard Deviation 14.8
|
|
Mean Inflammatory High-Sensitive C-Reactive Protein (hsCRP) in High Risk and Very High Risk Dyslipidemic Participants
1 Year
|
4.3 mg/L
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: Baseline up to 12 months post-enrollmentPopulation: Clinical events were assessed among participants requiring LMTs with available data in the Full Analysis Set.
The safety outcome measure reports clinical events based on information captured in patient files/medical records. Participants may have reported more than one clinical event associated with any LMT.
Outcome measures
| Measure |
High Risk and Very High Risk Dyslipidemic Participants
n=8931 Participants
Participants were classified as High and Very High Risk (as assessed by the Framingham risk score for High Risk participants and the SMART score for Very High Risk participants) as well as if previously or newly diagnosed.
|
|---|---|
|
Number of Participants With Clinical Events Associated With Treatment Modalities, For Any LMT
Patients with any clinical event associated with treatment modalities
|
423 Participants
|
|
Number of Participants With Clinical Events Associated With Treatment Modalities, For Any LMT
Patients with muscle-associated symptoms
|
338 Participants
|
|
Number of Participants With Clinical Events Associated With Treatment Modalities, For Any LMT
Patient with new-onset and/or worsening of diabetes mellitus
|
2 Participants
|
|
Number of Participants With Clinical Events Associated With Treatment Modalities, For Any LMT
Patients with reduced kidney function
|
19 Participants
|
|
Number of Participants With Clinical Events Associated With Treatment Modalities, For Any LMT
Patients with neurocognitive impairment
|
8 Participants
|
|
Number of Participants With Clinical Events Associated With Treatment Modalities, For Any LMT
Patients with laboratory abnormality/abnormalities
|
59 Participants
|
|
Number of Participants With Clinical Events Associated With Treatment Modalities, For Any LMT
Patients with missing event-type
|
28 Participants
|
|
Number of Participants With Clinical Events Associated With Treatment Modalities, For Any LMT
Patients without any event
|
8508 Participants
|
Adverse Events
High Risk and Very High Risk Dyslipidemic Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 153 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place