Clinical trial • Not applicable • Cardiology
Ramipril; Acetylsalicylic acid; Atorvastatin calcium trihydrate for Acute coronary syndrome
Not applicable trial of Ramipril; Acetylsalicylic acid; Atorvastatin calcium trihydrate for Acute coronary syndrome.
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Acute coronary syndrome
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 04-12-2025
- First CTIS Authorization Date
- 30-03-2026
Trial design
Randomised, open-label, test: trinomia 100 mg/40 mg/2,5 mg cápsulas duras. (polypill combination product). comparators (separate products): acovil 10 mg comprimidos (ramipril 10 mg), adiro 100 mg comprimidos gastrorresistentes (acetylsalicylic acid 100 mg), cardyl 40 mg comprimidos recubiertos con película (atorvastatin 40 mg). treatment period up to 12 months; no detailed dosing schedule or frequency specified in ctis record.-controlled Not applicable trial across 1 site in Spain.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Test: Trinomia 100 mg/40 mg/2,5 mg cápsulas duras. (polypill combination product). Comparators (separate products): Acovil 10 mg comprimidos (ramipril 10 mg), Adiro 100 mg comprimidos gastrorresistentes (acetylsalicylic acid 100 mg), Cardyl 40 mg comprimidos recubiertos con película (atorvastatin 40 mg). Treatment period up to 12 months; no detailed dosing schedule or frequency specified in CTIS record.
- Target Sample Size
- 216
- Trial Duration For Participant
- 365
Eligibility
Recruits 216 Vulnerable population not selected. Exclusion includes "Refusal or inability to provide informed consent". Only adult participants are eligible and consent is required from the participant (no assent procedures specified)..
- Vulnerable Population
- Vulnerable population not selected. Exclusion includes "Refusal or inability to provide informed consent". Only adult participants are eligible and consent is required from the participant (no assent procedures specified).
Inclusion criteria
- {"criterion_text":"- 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
- {"criterion_text":"- Contraindication to any of the components of the polypill"}
- {"criterion_text":"- Refusal or inability to provide informed consent"}
- {"criterion_text":"- Inability to complete clinical follow-up"}
- {"criterion_text":"- 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 endpoints
- {"endpoint_text":"- 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","definition_or_measurement_approach":"Assessment at the coordinating center one year after admission using four methods: Morisky Green, Haynes-Sackett, attendance at follow-up visits, and pharmacy medication pick-up; patients considered adherent if they meet the adherence criteria for all four methods. Assessment performed by a nursing team blinded to treatment assignment."}
Secondary endpoints
- {"endpoint_text":"- Analysis of drug levels","definition_or_measurement_approach":"Measure drug levels (acetylsalicylic acid, ramipril, atorvastatin) in blood, urine, and hair samples and correlate these variables with a scale assessing therapeutic adherence (as described in protocol objectives)."}
- {"endpoint_text":"- Control of cardiovascular risk factors","definition_or_measurement_approach":""}
- {"endpoint_text":"- Quality of life","definition_or_measurement_approach":""}
- {"endpoint_text":"- Functional capacity for basic activities of daily living (ADLs)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Ability to perform instrumental activities of daily living (IADLs)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Cognitive status","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 216
- Recruitment Window Months
- 20
- Consent Approach
- Informed consent required from adult participants; exclusion for "Refusal or inability to provide informed consent". Subject information and informed consent form documents are provided (adult ICF and qualitative interview ICF). No assent procedures or specific languages for consent documents are specified in the CTIS record.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 216
Spain
- Earliest CTIS Part Ii Submission Date
- 16-03-2026
- Latest Decision Or Authorization Date
- 30-03-2026
- Processing Time Days
- 14
- Number Of Sites
- 1
- Number Of Participants
- 216
Sites
- Site Name
- Bellvitge University Hospital
- Department Name
- Cardiologia
- Principal Investigator Name
- Elena Calvo Barriuso
- Principal Investigator Email
- ebarriuso@bellvitgehospital.cat
- Contact Person Name
- Elena Calvo Barriuso
- Contact Person Email
- ebarriuso@bellvitgehospital.cat
Sponsor
Primary sponsor
- Full Name
- Fundacion Epic
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- Trinomia 100 mg/40 mg/2,5 mg cápsulas duras.
- Active Substance
- Ramipril; Acetylsalicylic acid; Atorvastatin calcium trihydrate
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Authorisation Status
- Marketing authorisation present (marketingAuthNumber: 81772)
- Starting Dose
- 100 mg/40 mg/2,5 mg (product strength as named)
- Investigational Product Name
- Acovil 10 mg comprimidos
- Active Substance
- Ramipril
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Authorisation Status
- Marketing authorisation present (marketingAuthNumber: 65104)
- Starting Dose
- 10 mg
- Maximum Dose
- 10 mg (max daily dose amount listed)
- Investigational Product Name
- Cardyl 40 mg comprimidos recubiertos con película
- Active Substance
- Atorvastatin
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Authorisation Status
- Marketing authorisation present (marketingAuthNumber: 61718)
- Starting Dose
- 40 mg
- Maximum Dose
- 40 mg (max daily dose amount listed)
- Investigational Product Name
- Adiro 100 mg comprimidos gastrorresistentes EFG
- Active Substance
- Acetylsalicylic acid
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Authorisation Status
- Authorised (product present in registry, prodName Adiro 100 mg)
- Starting Dose
- 100 mg
- Maximum Dose
- 100 mg (max daily dose amount listed)
- Combination Treatment
- Yes
Related trials
Other published trials that may interest you.