Impact of a Ramipril, Acetylsalicylic Acid, and Atorvastatin Combination Therapy and Nurse-Led Education on Medication Adherence in Patients with Acute Coronary Syndrome

The primary objective of this study is to evaluate the additive effect of prescribing a cardiovascular polypill at hospital discharge in combination with a nurse-led education program on therapeutic adherence one year after admission in patients with acute coronary syndrome. 5

The secondary objectives include:

• Assessment of adherence differences based on sex.
• Evaluation of quality of life according to the treatment strategy.
• Measurement of drug levels for acetylsalicylic acid, ramipril, and atorvastatin in blood, urine, and hair samples to correlate with adherence scales.
• Evaluation of all-cause readmission, mortality, and cardiovascular events, such as reinfarction or revascularization, one year post-admission.
• Assessment of days alive and out of hospital during the first year.
• Qualitative analysis of clinical follow-up experiences, factors influencing adherence, and associated emotions.

The sponsor did not provide information regarding the total number of participants. The study population consists of adult patients, including both males and females, diagnosed with acute coronary syndrome. Inclusion is limited to individuals admitted to study centers between September 2024 and September 2026 who present with ischemia-suggestive chest pain and specific electrocardiographic changes, such as T-wave inversion, ST-segment elevation or depression, or new onset left bundle branch block. Additionally, participants must demonstrate high-sensitivity troponin elevation exceeding the laboratory reference threshold.

This randomized controlled trial is designed to evaluate the additive impact of a cardiovascular polypill and a nurse-led education program on therapeutic adherence in patients diagnosed with acute coronary syndrome. The study compares the administration of a single product containing ramipril, acetylsalicylic acid, and atorvastatin calcium trihydrate against the use of three separate comparator medications. The methodology involves an initial screening to confirm eligibility based on ischemic chest pain, specific electrocardiographic changes, or elevated high-sensitivity troponin levels. Following hospital discharge, participants undergo a follow-up period to assess primary outcomes. Adherence is evaluated one year after admission using four distinct methods: the Morisky Green scale, the Haynes-Sackett method, attendance at scheduled visits, and pharmacy medication pick-up. A nursing team, blinded to the treatment assignment, performs these assessments to minimize bias. Secondary endpoints include the analysis of drug levels, control of cardiovascular risk factors, quality of life, functional capacity, and cognitive status. The total duration of the study is expected to conclude by October 2027.

The experimental treatment consists of Trinomia, a fixed-dose combination administered as a hard capsule. Each capsule contains 100 mg of ramipril, 40 mg of atorvastatin calcium trihydrate, and 2.5 mg of acetylsalicylic acid. This medication is administered via the oral route.

The comparator group receives three separate medications to represent standard therapy for acute coronary syndrome. The first component is Acovil, consisting of 10 mg of ramipril provided in tablet form for oral administration. The second component is Cardyl, which provides 40 mg of atorvastatin in a film-coated tablet for oral use. The third component is Adiro, containing 100 mg of acetylsalicylic acid in a gastro-resistant tablet for oral administration.

The primary efficacy endpoint is the assessment of therapeutic adherence performed one year after hospital admission. This evaluation is conducted using a combined methodology involving the Morisky Green scale, the Haynes-Sackett scale, follow-up visit attendance, and pharmacy medication pick-up records. Adherence is defined by meeting the specified criteria across all four measurement methods. To mitigate bias, the assessment is performed by a nursing team blinded to the assigned treatment groups.

Secondary endpoints include the following parameters:

• Drug levels analysis;
• 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.