Randomized clinical trial to assess the efficacy and safety of a strategy for primary prevention of cardiovascular disease in patients with inflammatory rheumatic diseases based on the use of carotid ultrasound.

2025-521086-28-00 Therapeutic use (Phase IV) Authorised, recruitment pending

Status Authorised, recruitment pending · 1 EU/EEA countries · 15 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Authorised, recruitment pending
Participants planned 1,250
Countries 1
Sites 15

CHRONIC INFLAMMATORY RHEUMATIC DISEASE: rheumatoid arthritis or psoriatic arthritis or axial spondyloarthritis or systemic lupus erythematosus

To analyze the efficacy of a primary prevention strategy for CV events in patients with inflammatory rheumatic diseases based on the use of carotid ultrasound to identify and treat those patients at high CV risk classified in the low-moderate SCORE groups, comparing it with the current strategy based on clinical guidel…

Key facts

Sponsor
Instituto De Investigacion Marques De Valdecilla
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Cardiovascular Diseases [C14]
Decision date (initial)
2025-10-03
Transition trial
No
Low-intervention
Yes
Rare-disease indication
No
Vulnerable population
No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Prophylaxis, Efficacy

To analyze the efficacy of a primary prevention strategy for CV events in patients with inflammatory rheumatic diseases based on the use of carotid ultrasound to identify and treat those patients at high CV risk classified in the low-moderate SCORE groups, comparing it with the current strategy based on clinical guidelines.

Secondary objectives 3

  1. To analyze individually the efficacy of this strategy in each of the diseases included (rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis).
  2. To compare the efficacy of this strategy in men and women.
  3. To analyze the safety of the strategy by comparing the adverse effects of the intervention group and those of the control group.

Conditions and MedDRA coding

CHRONIC INFLAMMATORY RHEUMATIC DISEASE: rheumatoid arthritis or psoriatic arthritis or axial spondyloarthritis or systemic lupus erythematosus

Study design 1 period

#TitleAllocationBlindingRoles blindedArms
1 Randomized clinical trial to efficacy and safety for primary prevention of cardiovascular
A strategy for primary prevention of cardiovascular disease in patients with inflammatory rheumatic diseases based on the use of carotid ultrasound.
 Randomised Controlled None experimental group: Treatment group: CAROTID ECHOGRAPHY
Control group: According the guides ESC

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

  1. Patients who have given written informed consent.
  2. Patients ≥50 years of age
  3. Patients meeting classification criteria for any of the following rheumatic CIS: rheumatoid arthritis (RA, ACR/EULAR criteria) or psoriatic arthritis (PsA, CASPAR criteria) or axial spondyloarthritis (EspAax, ASAS criteria) or systemic lupus erythematosus (SLE, ACR/EULAR criteria) (annex IV)
  4. Patients included in the low-moderate CV risk groups according to SCORE2/OP (Annex V)

Exclusion criteria 3

  1. Presence of CV events, type 2 DM, familial hypercholesterolemia or chronic kidney disease that imply classification in the high/very high CV risk groups.
  2. Patients who, either in the context of research studies or as a result of decisions made in routine clinical practice, and meeting the previously mentioned inclusion criteria, have undergone carotid ultrasound and therapeutic intervention as a consequence.
  3. Patients with contraindications to lipid-lowering therapies, including a history of recent alcoholism and the presence of active liver disease or with unwarranted and persistent elevations of serum transaminases exceeding three times the maximum normal value (for statins and ezetimibe).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. occurrence of a major cardiovascular event: acute myocardial infarction or stroke, hospital admission for unstable angina, arterial revascularization for peripheral artery disease, death due to CV disease

Secondary endpoints 1

  1. individualized appearance of each of the cardiovascular events that make up the primary endpoint

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Amlodipine

SCP182103 · ATC

Active substance
Amlodipine
Route of administration
ORAL USE
Max daily dose
80 mg milligram(s)
Max total dose
80
Max treatment duration
48 Week(s)
Authorisation status
Authorised
ATC code
C10BX03 — ATORVASTATIN AND AMLODIPINE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Bempedoic Acid

SCP42319183 · ATC

Active substance
Bempedoic Acid
Route of administration
ORAL USE
Max daily dose
180 mg milligram(s)
Max total dose
180 mg milligram(s)
Max treatment duration
48 Month(s)
Authorisation status
Authorised
ATC code
C10AX15 — BEMPEDOIC ACID
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Lactose Monohydrate

SCP107976644 · ATC

Active substance
Lactose Monohydrate
Substance synonyms
LACTOSE hydrate
Route of administration
ORAL USE
Max daily dose
40 mg milligram(s)
Max total dose
40 mg milligram(s)
Max treatment duration
48 Week(s)
Authorisation status
Authorised
ATC code
C10BA06 — ROSUVASTATIN AND EZETIMIBE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Comparator 1

Lactose Monohydrate

SCP107976644 · ATC

Active substance
Lactose Monohydrate
Substance synonyms
LACTOSE hydrate
Route of administration
ORAL USE
Max daily dose
40 mg milligram(s)
Max total dose
40 mg milligram(s)
Max treatment duration
48 Month(s)
Authorisation status
Authorised
ATC code
C10BA06 — ROSUVASTATIN AND EZETIMIBE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Instituto De Investigacion Marques De Valdecilla

4 Total trials 2 Recruiting
Academic / Non-commercial
Sponsor organisation
Instituto De Investigacion Marques De Valdecilla
Address
Avenida Del Cardenal Herrera Oria S/n
City
Santander
Postcode
39011
Country
Spain

Scientific contact point

Organisation
Instituto De Investigacion Marques De Valdecilla
Contact name
mar garcia

Public contact point

Organisation
Instituto De Investigacion Marques De Valdecilla
Contact name
mar garcia

Locations

1 EU/EEA country · 15 investigational sites

By country

CountryMS statusPlanned subjectsSites
Spain Authorised, recruitment pending 1,250 15
Rest of world — 0 —

Investigational sites

Spain

15 sites · Authorised, recruitment pending
Hospital Universitario Araba
reumatologia, Jose Achotegui Kalea S/N, 01009, Vitoria
Hospital Universitario La Paz
reumatologia, Paseo De La Castellana 261, 28046, Madrid
El Hospital Universitario De Gran Canaria Dr. Negrin
reumatologia, Barranco De La Ballena S N, 35010, Las Palmas De Gran Canaria
Hospital Universitario Marques De Valdecilla
reumatologia, Avenida Valdecilla Sn, 39008, Santander
Hospital Universitari Vall D Hebron
reumatologia, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Sierrallana
reumatologia, Barrio Ganzo s/n, 39300, Torrelavega
Hospital Son Llatzer
reumatologia, Carretera De Manacor Km 4, 07198, Palma
University Clinical Hospital Virgen De La Arrixaca
reumatologia, Carretera Madrid-Cartagena S/N, El Palmar, Murcia
Hospital Universitario Basurto
reumatologia, Montevideo Etorbidea 16-18, 48013, Bilbao
Hospital laredo
reumatologia, avd.derechos humanos, 39770
Hospital Universitario Reina Sofia
reumatologia, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Universitario De Canarias
reumatologia, Carretera Ofra S/N, 38320, San Cristobal De La Laguna
Hospital General Universitario De Ciudad Real
reumatologia, Calle Del Obispo Rafael Torija S/n, 13005, Ciudad Real
Hospital Vega Baja De Orihuela
reumatologia, Carretera Almoradi S/n, 03325, Orihuela
Hospital Universitario San Juan De Alicante
reumatologia, Carretera N-332 Alicante-Valencia S/n, 03550, Sant Joan D'alacant

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol 2025-521086-28-00 1
Protocol (for publication) D1_Protocol 2025-521086-28-00_clean 2
Recruitment arrangements (for publication) K1_ Recruitment arrangements 1
Subject information and informed consent form (for publication) L1_SIS and ICF 2025-521086-28-00 1
Subject information and informed consent form (for publication) L1_SIS and ICF 2025-521086-28-00_ 2
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC acido bempedoico 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC atorvastatina 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC rosuvastatina 1
Synopsis of the protocol (for publication) D1_Protocol synopsis 2025-521086-28-00 1

Application history

3 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-06-19 Spain Acceptable
2025-09-29
 2025-10-03
2 SUBSTANTIAL MODIFICATION SM-1 2026-01-16 Spain Acceptable 2026-02-02
3 SUBSTANTIAL MODIFICATION SM-2 2026-02-03 Spain Acceptable 2026-02-10

Related clinical trials