Clinical trial • Phase IV • Cardiology
Ramipril; Acetylsalicylic acid; Atorvastatin calcium trihydrate for Ischemic heart disease | Acute coronary syndrome
Phase IV trial of Ramipril; Acetylsalicylic acid; Atorvastatin calcium trihydrate for Ischemic heart disease | Acute coronary syndrome.
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Ischemic heart disease | Acute coronary syndrome
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 27-10-2024
- First CTIS Authorization Date
- 04-11-2024
Trial design
Acovil 2,5 mg comprimidos; Cardyl 20 mg comprimidos recubiertos con película; Cardyl 40 mg comprimidos recubiertos con película; Acovil 10 mg comprimidos; Acovil 5 mg comprimidos; Adiro 100 mg comprimidos gastrorresistentes EFG (names and doses as stated in product list).-controlled, crossover Phase IV trial in Spain.
- Comparator
- Acovil 2,5 mg comprimidos; Cardyl 20 mg comprimidos recubiertos con película; Cardyl 40 mg comprimidos recubiertos con película; Acovil 10 mg comprimidos; Acovil 5 mg comprimidos; Adiro 100 mg comprimidos gastrorresistentes EFG (names and doses as stated in product list).
- Crossover
- Yes
- Target Sample Size
- 88
- Trial Duration For Participant
- 180
Eligibility
Recruits 88 No vulnerable population selected. Eligible subjects are adults (Patients over 18 years of age) and must sign the informed consent. No assent procedures or paediatric consent processes are indicated..
- Vulnerable Population
- No vulnerable population selected. Eligible subjects are adults (Patients over 18 years of age) and must sign the informed consent. No assent procedures or paediatric consent processes are indicated.
Inclusion criteria
- {"criterion_text":"- Patients over 18 years of age."}
- {"criterion_text":"- Patients with ischemic heart disease under treatment with the Trinomia® polypill in any of its presentations for secondary prevention and who can make the 6 visits necessary to complete the study."}
- {"criterion_text":"- Patients who sign the Informed Consent."}
Exclusion criteria
- {"criterion_text":"- Patients who do not sign the informed consent."}
- {"criterion_text":"- Patients with an inability to understand and comply with the protocol."}
- {"criterion_text":"- Patients with contraindication to any component of the polypill."}
- {"criterion_text":"- Patients who are already participating in another clinical trial."}
- {"criterion_text":"- Patients with any condition that limits life expectancy to <1 year."}
- {"criterion_text":"- Patients with programmed coronary revascularization."}
- {"criterion_text":"- Patients with coronary stent implantation in the last 12 months."}
- {"criterion_text":"- Patients treated with any antithrombotic drug in addition to acetylsalicylic acid, that is, low molecular weight heparin, P2Y12 receptor inhibitors, or oral anticoagulants."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Systolic blood pressure level.","definition_or_measurement_approach":"To analyze the level of systolic blood pressure in the same patient in 2 different periods: one under treatment of 3 months with the Trinomia® polypill and another of 3 months with the components separately."}
- {"endpoint_text":"- LDL cholesterol.","definition_or_measurement_approach":"To analyze the level of LDL-cholesterol in the same patient in 2 different periods: one under treatment of 3 months with the Trinomia® polypill and another of 3 months with the components separately."}
Secondary endpoints
- {"endpoint_text":"- Systolic blood pressure level.","definition_or_measurement_approach":""}
- {"endpoint_text":"- LDL cholesterol.","definition_or_measurement_approach":""}
Other endpoints
- {"endpoint_text":"- Total cholesterol and HDL.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Diastolic blood pressure level.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Patient satisfaction level.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Degree of adherence to treatment.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Platelet aggregation degree with thromboxane A2 kit.","definition_or_measurement_approach":"Measured using a thromboxane A2 kit (as stated: 'Platelet aggregation degree with thromboxane A2 kit')."}
- {"endpoint_text":"- Adverse events.","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 88
- Recruitment Window Months
- 36
- Consent Approach
- Informed consent must be signed by the participant (Patients who sign the Informed Consent). Subject information and informed consent form documents are present (L1_SIS, L1_ICF). Participants are adults (>18); no assent or paediatric consent procedures are indicated. Language of translations includes Spanish.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 88
Spain
- Earliest CTIS Part Ii Submission Date
- 04-10-2024
- Latest Decision Or Authorization Date
- 04-11-2024
- Processing Time Days
- 31
- Number Of Sites
- 1
- Number Of Participants
- 88
Sites
- Site Name
- Hospital Universitario De Cabuenes
- Department Name
- CARDILOGY
- Principal Investigator Name
- IÑIGO LOZANO MARTINEZ-LUENGAS
- Principal Investigator Email
- inigo.lozano@gmail.com
- Contact Person Name
- IÑIGO LOZANO MARTINEZ-LUENGAS
- Contact Person Email
- inigo.lozano@gmail.com
Sponsor
Primary sponsor
- Full Name
- Fundacion Epic
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- Trinomia 100 mg/20 mg/10 mg cápsulas duras.
- Active Substance
- Ramipril; Acetylsalicylic acid; Atorvastatin calcium trihydrate
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- oral
- Authorisation Status
- Authorised
- Dose Levels
- 100 mg / 20 mg / 10 mg
- Maximum Dose
- 130 mg (maxDailyDoseAmount 130)
- Investigational Product Name
- Trinomia 100 mg/20 mg/5 mg cápsulas duras.
- Active Substance
- Ramipril; Acetylsalicylic acid; Atorvastatin calcium trihydrate
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- oral
- Authorisation Status
- Authorised
- Dose Levels
- 100 mg / 20 mg / 5 mg
- Maximum Dose
- 125 mg (maxDailyDoseAmount 125)
- Investigational Product Name
- Trinomia 100 mg/40 mg/10 mg cápsulas duras.
- Active Substance
- Ramipril; Acetylsalicylic acid; Atorvastatin calcium trihydrate
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- oral
- Authorisation Status
- Authorised
- Dose Levels
- 100 mg / 40 mg / 10 mg
- Maximum Dose
- 150 mg (maxDailyDoseAmount 150)
- Investigational Product Name
- Trinomia 100 mg/40 mg/5 mg cápsulas duras.
- Active Substance
- Ramipril; Acetylsalicylic acid; Atorvastatin calcium trihydrate
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- oral
- Authorisation Status
- Authorised
- Dose Levels
- 100 mg / 40 mg / 5 mg
- Maximum Dose
- 145 mg (maxDailyDoseAmount 145)
- Investigational Product Name
- Trinomia 100 mg/20 mg/2,5 mg cápsulas duras.
- Active Substance
- Ramipril; Acetylsalicylic acid; Atorvastatin calcium trihydrate
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- oral
- Authorisation Status
- Authorised
- Dose Levels
- 100 mg / 20 mg / 2.5 mg
- Maximum Dose
- 122.5 mg (maxDailyDoseAmount 122.5)
- 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 USE
- Route
- oral
- Authorisation Status
- Authorised
- Dose Levels
- 100 mg / 40 mg / 2.5 mg
- Maximum Dose
- 142.5 mg (maxDailyDoseAmount 142.5)
- Investigational Product Name
- Acovil 2,5 mg comprimidos
- Active Substance
- Ramipril
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- oral
- Authorisation Status
- Authorised
- Dose Levels
- 2.5 mg
- Maximum Dose
- 2.5 mg (maxDailyDoseAmount 2.5)
- Investigational Product Name
- Cardyl 20 mg comprimidos recubiertos con película
- Active Substance
- Atorvastatin
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- oral
- Authorisation Status
- Authorised
- Dose Levels
- 20 mg
- Maximum Dose
- 20 mg (maxDailyDoseAmount 20)
- Investigational Product Name
- Cardyl 40 mg comprimidos recubiertos con película
- Active Substance
- Atorvastatin
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- oral
- Authorisation Status
- Authorised
- Dose Levels
- 40 mg
- Maximum Dose
- 40 mg (maxDailyDoseAmount 40)
- Investigational Product Name
- Acovil 10 mg comprimidos
- Active Substance
- Ramipril
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- oral
- Authorisation Status
- Authorised
- Dose Levels
- 10 mg
- Maximum Dose
- 10 mg (maxDailyDoseAmount 10)
- Investigational Product Name
- Acovil 5 mg comprimidos
- Active Substance
- Ramipril
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- oral
- Authorisation Status
- Authorised
- Dose Levels
- 5 mg
- Maximum Dose
- 5 mg (maxDailyDoseAmount 5)
- Investigational Product Name
- Adiro 100 mg comprimidos gastrorresistentes EFG
- Active Substance
- Acetylsalicylic acid
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- oral
- Authorisation Status
- Authorised
- Dose Levels
- 100 mg
- Maximum Dose
- 100 mg (maxDailyDoseAmount 100)
- Combination Treatment
- Yes
Related trials
Other published trials that may interest you.
- METHYLPREDNISOLONE for Fulminant myocarditis
- PELACARSEN for Cardiovascular disease | Arteriosclerotic cardiovascular disease
- clopidogrel for Acute coronary syndrome | Cardiovascular diseases
- APIXABAN for Venous thromboembolism
- SOTAGLIFLOZIN for Obstructive hypertrophic cardiomyopathy | Non-obstructive hypertrophic cardiomyopathy