Treatment of High and Very High riSk Dyslipidemic pAtient... | NCT04271280

NCT04271280

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High Risk and Very High Risk Dyslipidemic Participants		Participants are 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.	Other: Non-interventional

Name	Type	Description	Arm Group Labels	Other Names
Non-interventional	Other	This is a non-interventional study.	High Risk and Very High Risk Dyslipidemic Participants

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Low Density Lipid-Cholesterol (LDL-C) Levels in High and Very High Risk Cardiovascular Participants	Blood plasma samples were used to assess LDL-C levels.	Baseline up to 12 months post-enrollment
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)	Clinical events were assessed based on information captured in patient files/medical records.	Baseline up to 12 months post-enrollment

Secondary Outcomes

Measure	Description	Time Frame
Mean Atherosclerotic Cardiovascular Disease (ASCVD)-Modifying Cholesterol Fragment Levels in High Risk and Very High Risk Dyslipidemic Participants	Blood plasma samples were used to assess ASCVD-modifying cholesterol fragment levels.	Baseline up to 12 months post-enrollment
Mean Apolipoprotein B Levels in High Risk and Very High Risk Dyslipidemic Participants

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Contact for Clinical Trial Information	Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Krankenhaus St. Josef Braunau GmbH		Braunau am Inn		5280	Austria
LKH-Univ. Klinikum Graz

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42373176	Derived	Toplak H, Komen JJ, Bardet A, Catapano AL, Ray KK; SANTORINI Investigators. Low-density lipoprotein cholesterol management and goal attainment at 1 year in patients with diabetes, pre-diabetes and normoglycaemia: results from the European, prospective, observational SANTORINI study. BMJ Open. 2026 Jun 29;16(6):e108737. doi: 10.1136/bmjopen-2025-108737.
42291044

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Aug 26, 2020

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

No data available

No data is available for this block.

Baseline demographic characteristics were assessed in the Baseline Analysis Set.

Arm/Group Information

ID	Title	Description
BG000	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.

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

- ParticipantsBG0009543

Title	Measurements
	BG00065.4± 10.9

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

- ParticipantsBG0009543

Title	Measurements
Female	BG0002618
Male

Race and Ethnicity Not Collected

Race and Ethnicity were not collected from any participant.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG0000

Region of Enrollment

Number

participants

Title

Denominators

Categories

United Kingdom

- ParticipantsBG0009543

Title	Measurements
	BG000658

Portugal

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Mean Low Density Lipid-Cholesterol (LDL-C) Levels in High and Very High Risk Cardiovascular Participants

Blood plasma samples were used to assess LDL-C levels.

Low Density Lipid-Cholesterol (LDL-C) levels were assessed in participants with available data in the Full Analysis Set.

Posted

Mean

Standard Deviation

mmol/L

Baseline up to 12 months post-enrollment

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG0008537

Title

Denominators

Categories

Baseline

- ParticipantsOG0008537

Title	Measurements
	OG0002.40± 1.20

1 Year

- ParticipantsOG000

Primary

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)

Clinical events were assessed based on information captured in patient files/medical records.

Treatment modalities were assessed among participants requiring LMTs with available data in the Full Analysis Set.

Posted

Count of Participants

Participants

Baseline up to 12 months post-enrollment

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

Mean Atherosclerotic Cardiovascular Disease (ASCVD)-Modifying Cholesterol Fragment Levels in High Risk and Very High Risk Dyslipidemic Participants

Blood plasma samples were used to assess ASCVD-modifying cholesterol fragment levels.

Mean ASCVD-modifying cholesterol levels were assessed in participants with available data in the Full Analysis Set.

Posted

Mean

Standard Deviation

mmol/L

Baseline up to 12 months post-enrollment

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

Mean Apolipoprotein B Levels in High Risk and Very High Risk Dyslipidemic Participants

Blood plasma samples were used to assess Apolipoprotein B levels.

Mean apolipoprotein B levels were assessed in participants with available data in the Full Analysis Set.

Posted

Mean

Standard Deviation

g/L

Baseline up to 12 months post-enrollment

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

Mean Lipid Protein A Levels in High Risk and Very High Risk Dyslipidemic Participants

Blood plasma samples were used to assess lipid Protein A levels.

Mean lipid protein A levels were assessed in participants with available data in the Full Analysis Set.

Posted

Mean

Standard Deviation

mg/dL

Baseline up to 12 months post-enrollment

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

Mean Inflammatory High-Sensitive C-Reactive Protein (hsCRP) in High Risk and Very High Risk Dyslipidemic Participants

Blood plasma samples were used to assess hsCRP levels.

Mean hsCRP levels were assessed in participants with available data in the Full Analysis Set.

Posted

Mean

Standard Deviation

mg/L

Baseline up to 12 months post-enrollment

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Clinical Events Associated With Treatment Modalities, For Any LMT

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.

Clinical events were assessed among participants requiring LMTs with available data in the Full Analysis Set.

Posted

Count of Participants

Participants

Baseline up to 12 months post-enrollment

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	High Risk and Very High Risk Dyslipidemic Participants	Participants were stratified 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.	153	9,136	0	0	0	0

Medication selection and adherence, lifestyle and other risk factors were decided on by routine care and patient choices, leading to potential bias: a selection bias of the included patients, an information bias on data collected, and a confounding bias in the treatment administration. In the current analysis, all eligible patients were included and no specific methods were employed to minimize bias or confounding effects.

Certain Agreements

ID	Term
D050171	Dyslipidemias
D002318	Cardiovascular Diseases
D006937	Hypercholesterolemia
D050197	Atherosclerosis

Ancestor Terms

ID	Term
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D006949	Hyperlipidemias
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases

- ParticipantsBG0009543