Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
216
Countries
1
Sites
1
Acute coronary syndrome
To evaluate, through a randomized controlled trial, the potential additive impact of prescribing the cardiovascular polypill at hospital discharge combined with the implementation of a nurse-led education program on therapeutic adherence one year after admission, in patients with acute coronary syndrome (ACS)
Key facts
- Sponsor
- Fundacion Epic
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Decision date (initial)
- 2026-03-30
- 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: Efficacy
To evaluate, through a randomized controlled trial, the potential additive impact of prescribing the cardiovascular polypill at hospital discharge combined with the implementation of a nurse-led education program on therapeutic adherence one year after admission, in patients with acute coronary syndrome (ACS)
Secondary objectives 6
- To assess differences in adherence according to sex.
- Evaluar la calidad de vida según la estrategia de tratamiento de estos pacientes.
- To measure drug levels (acetylsalicylic acid, ramipril, atorvastatin) in blood, urine, and hair samples according to treatment strategy, and correlate these variables with a scale assessing therapeutic adherence.
- To evaluate the rate of all-cause readmission, mortality, and cardiovascular events (reinfarction, revascularization, etc.) one year after admission, according to treatment strategy.
- To assess the number of days alive and out of hospital (DAOH) during the first year after admission, according to the patients’ treatment strategy.
- To evaluate, through a qualitative study: 1) the experience related to clinical follow-up and treatments received from healthcare professionals over one year; 2) identify factors related to therapeutic adherence in the study population; 3) explore feelings and emotions associated with clinical follow-up and treatments received from the healthcare perspective.
Conditions and MedDRA coding
Acute coronary syndrome
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10051592 | Acute coronary syndrome | 100000004849 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Adult patients admitted for acute coronary syndrome (ACS) at the study centers between September 2024 and September 2026. ACS will be defined as chest pain suggestive of ischemia accompanied by electrocardiographic changes indicative of myocardial ischemia (T-wave inversion, ST-segment elevation or depression, new onset left bundle branch block) and/or high-sensitivity troponin elevation above the laboratory reference threshold
Exclusion criteria 4
- Contraindication to any of the components of the polypill
- Refusal or inability to provide informed consent
- Inability to complete clinical follow-up
- Patients admitted to long-term care facilities or nursing homes at the time of inclusion and/or during the one-year follow-up
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Adherence will be assessed at the coordinating center one year after admission. A combined evaluation of adherence will be conducted using four methods: Morisky Green, Haynes-Sackett, attendance at follow-up visits, and pharmacy medication pick-up. Patients will be considered adherent if they meet the adherence criteria for all four methods used. The assessment of therapeutic adherence will be performed by a nursing team blinded to the patient’s assigned treatment group, to minimize bias
Secondary endpoints 6
- Analysis of drug levels
- Control of cardiovascular risk factors
- Quality of life
- Functional capacity for basic activities of daily living (ADLs)
- Ability to perform instrumental activities of daily living (IADLs)
- Cognitive status
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Trinomia 100 mg/40 mg/2,5 mg cápsulas duras.
PRD4760729 · Product
- Active substance
- Ramipril
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 142.50 mg milligram(s)
- Max total dose
- 52012.50 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- C10BX06 — -
- Marketing authorisation
- 81772
- MA holder
- FERRER INTERNACIONAL, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 3
Adiro 100 mg comprimidos gastrorresistentes EFG
PRD450046 · Product
- Active substance
- Acetylsalicylic Acid
- Pharmaceutical form
- GASTRO-RESISTANT TABLET
- Route of administration
- ORAL
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 36500 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AC06 — ACETYLSALICYLIC ACID
- Marketing authorisation
- 62.825
- MA holder
- BAYER HISPANIA SL
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD485274 · Product
- Active substance
- Ramipril
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 3650 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- C09AA05 — RAMIPRIL
- Marketing authorisation
- 65104
- MA holder
- SANOFI-AVENTIS, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cardyl 40 mg comprimidos recubiertos con película
PRD9994593 · Product
- Active substance
- Atorvastatin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 14600 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- C10AA05 — ATORVASTATIN
- Marketing authorisation
- 61718
- MA holder
- VIATRIS HEALTHCARE LIMITED
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacion Epic
- Sponsor organisation
- Fundacion Epic
- Address
- Avenida Condesa Sagasta 10 1c
- City
- Leon
- Postcode
- 24001
- Country
- Spain
Scientific contact point
- Organisation
- Fundacion Epic
- Contact name
- Elena Calvo Barriuso
Public contact point
- Organisation
- Fundacion Epic
- Contact name
- Elena Calvo Barriuso
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 216 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Bellvitge University Hospital
Cardiologia, Carrer De La Feixa Llarga S/N, 08907, L'Hospitalet De Llobregat
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.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Protocol 2025-524751-32-00_redacted | 6 |
| Recruitment arrangements (for publication) | K1_K2_Recruitment arrangements and material 2025-524751-32-00 | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adult 2025-524751-32-00 | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF cualitative interview_2025-524751-32-00 | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Acovil | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Adiro | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Cardyl | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC trinomia | 1.0 |
| Synopsis of the protocol (for publication) | Protocol synopsis 2025-524751-32-00 | 6 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-04 | Spain | Acceptable 2026-03-23
|
2026-03-30 |