NCT04271280: SANTORINI

Treatment of High and Very High riSk Dyslipidemic pAtients for the PreveNTion of CardiOvasculaR Events

Completed Results posted Last updated 20 February 2024

What this trial tests

trial testing Non-interventional in Dyslipidemia in 9,559 participants. Completed in 11 April 2022.

Timeline

17 March 2020

Primary endpoint
11 April 2022

11 April 2022

Quick facts

Lead sponsor	Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Status	Completed
Study type	OBSERVATIONAL
Enrollment	9,559
Start date	17 March 2020
Primary completion	11 April 2022
Estimated completion	11 April 2022
Sites	540 locations across France, Denmark, Finland, Italy, Netherlands, Belgium, Austria, Sweden

Drugs / interventions tested

• Non-interventional

Conditions studied

• Dyslipidemia — all drugs for Dyslipidemia →
• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →
• Hypercholesterolemia — all drugs for Hypercholesterolemia →
• Atherosclerotic Cardiovascular Disease — all drugs for Atherosclerotic Cardiovascular Disease →

Sponsor

Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company — full company profile →

Who can join

18 and older, any sex, with Dyslipidemia or Cardiovascular Diseases. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Low Density Lipid-Cholesterol (LDL-C) Levels in High and Very High Risk Cardiovascular Participants Primary · Baseline up to 12 months post-enrollment

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

Baseline

Group	Value	95% CI
High Risk and Very High Risk Dyslipidemic Participants	2.40	± 1.20

1 Year

Group	Value	95% CI
High Risk and Very High Risk Dyslipidemic Participants	1.99	± 0.94

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) Primary · Baseline up to 12 months post-enrollment

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

Received any LMT

Group	Value	95% CI
High Risk and Very High Risk Dyslipidemic Participants	8931

Received any statin

Group	Value	95% CI
High Risk and Very High Risk Dyslipidemic Participants	7680

Received any ezetimibe

Group	Value	95% CI
High Risk and Very High Risk Dyslipidemic Participants	2538

Received any other LMT

Group	Value	95% CI
High Risk and Very High Risk Dyslipidemic Participants	2128

Mean Atherosclerotic Cardiovascular Disease (ASCVD)-Modifying Cholesterol Fragment Levels in High Risk and Very High Risk Dyslipidemic Participants Secondary · Baseline up to 12 months post-enrollment

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

Baseline: HDL-C

Group	Value	95% CI
High Risk and Very High Risk Dyslipidemic Participants	1.27	± 0.40

1 Year: HDL-C

Group	Value	95% CI
High Risk and Very High Risk Dyslipidemic Participants	1.28	± 0.39

Baseline: Non-HDL-C

Group	Value	95% CI
High Risk and Very High Risk Dyslipidemic Participants	3.02	± 1.35

1 Year: Non-HDL-C

Group	Value	95% CI
High Risk and Very High Risk Dyslipidemic Participants	2.58	± 1.06

Baseline: Total Cholesterol

Group	Value	95% CI
High Risk and Very High Risk Dyslipidemic Participants	4.31	± 1.40

1 Year: Total Cholesterol

Group	Value	95% CI
High Risk and Very High Risk Dyslipidemic Participants	3.86	± 1.13

Baseline: Triglycerides

Group	Value	95% CI
High Risk and Very High Risk Dyslipidemic Participants	1.70	± 1.17

1 Year: Triglycerides

Group	Value	95% CI
High Risk and Very High Risk Dyslipidemic Participants	1.56	± 1.04

Mean Apolipoprotein B Levels in High Risk and Very High Risk Dyslipidemic Participants Secondary · Baseline up to 12 months post-enrollment

Blood plasma samples were used to assess Apolipoprotein B levels.

Baseline

Group	Value	95% CI
High Risk and Very High Risk Dyslipidemic Participants	0.92	± 0.39

1 Year

Group	Value	95% CI
High Risk and Very High Risk Dyslipidemic Participants	0.80	± 0.34

Mean Lipid Protein A Levels in High Risk and Very High Risk Dyslipidemic Participants Secondary · Baseline up to 12 months post-enrollment

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

Baseline

Group	Value	95% CI
High Risk and Very High Risk Dyslipidemic Participants	47.97	± 53.87

1 Year

Group	Value	95% CI
High Risk and Very High Risk Dyslipidemic Participants	51.24	± 53.47

Mean Inflammatory High-Sensitive C-Reactive Protein (hsCRP) in High Risk and Very High Risk Dyslipidemic Participants Secondary · Baseline up to 12 months post-enrollment

Blood plasma samples were used to assess hsCRP levels.

Baseline

Group	Value	95% CI
High Risk and Very High Risk Dyslipidemic Participants	6.90	± 14.8

1 Year

Group	Value	95% CI
High Risk and Very High Risk Dyslipidemic Participants	4.3	± 10.4

Number of Participants With Clinical Events Associated With Treatment Modalities, For Any LMT Secondary · Baseline up to 12 months post-enrollment

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.

Patients with any clinical event associated with treatment modalities

Group	Value	95% CI
High Risk and Very High Risk Dyslipidemic Participants	423

Patients with muscle-associated symptoms

Group	Value	95% CI
High Risk and Very High Risk Dyslipidemic Participants	338

Patient with new-onset and/or worsening of diabetes mellitus

Group	Value	95% CI
High Risk and Very High Risk Dyslipidemic Participants	2

Patients with reduced kidney function

Group	Value	95% CI
High Risk and Very High Risk Dyslipidemic Participants	19

Patients with neurocognitive impairment

Group	Value	95% CI
High Risk and Very High Risk Dyslipidemic Participants	8

Patients with laboratory abnormality/abnormalities

Group	Value	95% CI
High Risk and Very High Risk Dyslipidemic Participants	59

Patients with missing event-type

Group	Value	95% CI
High Risk and Very High Risk Dyslipidemic Participants	28

Patients without any event

Group	Value	95% CI
High Risk and Very High Risk Dyslipidemic Participants	8508

Sponsor's own description

High and Very High Risk cardiovascular patient journeys seems to vary from country to country, and current understanding of the process is incomplete. This real-life observational study which documents meaningful patient journey-related parameters can be expected to provide meaningful insight into the care process, country-by-country.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Treatment gaps in the implementation of LDL cholesterol control among high- and very high-risk patients in Europe between 2020 and 2021: the multinational observational SANTORINI study.
   Ray KK, Haq I, Bilitou A, Manu MC, et al · · 2023 · cited 194× · PMID 37090089 · DOI 10.1016/j.lanepe.2023.100624
2. Evaluation of contemporary treatment of high- and very high-risk patients for the prevention of cardiovascular events in Europe - Methodology and rationale for the multinational observational SANTORINI study.
   Ray KK, Haq I, Bilitou A, Aguiar C, et al · · 2021 · cited 26× · PMID 36644508 · DOI 10.1016/j.athplu.2021.08.003
3. Failure of LDL-C goals achievement and underuse of lipid-lowering therapies in patients at high and very high cardiovascular risk: Spanish subset from the European SANTORINI study.
   Mostaza JM, García-Ortiz L, Suárez Tembra MA, Talavera Calle P, et al · · 2025 · cited 5× · PMID 39613100 · DOI 10.1016/j.rceng.2024.11.004
4. Simulation of bempedoic acid and ezetimibe in the lipid-lowering treatment pathway in Austria using the contemporary SANTORINI cohort of high and very high risk patients.
   Toplak H, Bilitou A, Alber H, Auer J, et al · · 2023 · cited 4× · PMID 37286910 · DOI 10.1007/s00508-023-02221-4
5. [Treatment and LDL cholesterol adjustment in patients with high and very high cardiovascular risk in Germany compared with Europe - data from the SANTORINI registry].
   Stürzebecher PE, Tünnemann-Tarr A, Tuppatsch K, Laufs U. · · 2023 · cited 4× · PMID 36858065 · DOI 10.1055/a-2009-5077
6. Lipid-lowering agents in solid organ transplant recipients.
   Mickiewicz A, Żegleń S, Kędzierska-Kapuza K, Heleniak Z, et al · · 2025 · cited 3× · PMID 40575919 · DOI 10.1093/ndt/gfaf104
7. Real-world changes in lipid-lowering therapy use and LDL-C goal attainment in high and very high cardiovascular risk patients in the UK: a secondary analysis of the European SANTORINI study 1-year follow-up.
   Connolly D, Fuat A, McCormack T, Mcnally D, et al · · 2026 · PMID 42031497 · DOI 10.1136/bmjopen-2025-114031
8. Lipid management in high cardiovascular risk patients in France: a comparison with rest of Europe patients from 1-year follow-up of SANTORINI.
   Ferrières J, Ray KK, Catapano AL, Allouche R, et al · · 2026 · PMID 41908045 · DOI 10.3389/fcvm.2026.1748457