Evaluation of Dual Antiplatelet Therapy with Ticagrelor and Acetylsalicylic Acid Versus Acetylsalicylic Acid Monotherapy Post-Coronary Artery Bypass Grafting in Acute Coronary Syndrome

The primary objective of the study is to evaluate whether **dual antiplatelet therapy** (DAPT) with ticagrelor and acetylsalicylic acid (ASA) compared to ASA alone enhances the 12-month outcome defined as major adverse cardiovascular events (MACE) following isolated **coronary artery bypass grafting** (CABG) in patients with **acute coronary syndrome** (ACS). This is clinically relevant as it aims to determine the optimal antiplatelet strategy to reduce cardiovascular complications in this high-risk patient population.

The clinical trial involves participants diagnosed with **coronary artery multi-vessel disease and left main stenosis**. The study population includes both male and female subjects aged 18 years and older. Participants have undergone first-time isolated Coronary Artery Bypass Grafting (CABG) due to an episode of acute coronary syndrome, such as STEMI, NSTEMI, or unstable angina, within six weeks prior to surgery. The trial does not include a vulnerable population. The sponsor has not provided information regarding the total number of participants. Participants were selected based on their medical condition and the requirement of having provided written informed consent. Lifestyle considerations such as diet, physical activity, or habits are not specified in the available data.

The clinical trial is designed to evaluate the efficacy of dual antiplatelet therapy (DAPT) with **ticagrelor** and **acetylsalicylic acid** (ASA) compared to ASA alone in patients who have undergone isolated coronary artery bypass grafting (CABG) due to acute coronary syndrome (ACS). The trial is structured as a randomized, double-blind, controlled study, ensuring that neither the participants nor the investigators are aware of the treatment assignments, thus minimizing bias. The trial is expected to span a duration of approximately 16 years, with an estimated recruitment start date of June 1, 2018, and an anticipated end date of March 31, 2034.

Participants will be involved in the study for a maximum treatment period of 379 days. The study visits are sequenced as follows: an initial inclusion (screening) visit to confirm eligibility based on criteria such as age (≥18 years) and recent CABG due to ACS, followed by regular follow-up visits to monitor the participants' health status and adherence to the treatment regimen. The primary endpoint is a composite of time to all-cause death, myocardial infarction, stroke, or new coronary revascularization within 12 months. Secondary endpoints include various cardiovascular events and hospitalizations. The end-of-study visit will conclude the participant's involvement, assessing the overall outcomes and any adverse events experienced during the trial.

Participants may be subject to early termination from the study if they experience significant adverse effects, withdraw consent, or fail to comply with the study protocol. The trial aims to provide valuable insights into the potential benefits of DAPT in reducing major adverse cardiovascular events in this patient population.

The clinical trial involves the administration of **acetylsalicylic acid** as one of the experimental medications. This medication is provided in the form of a **tablet** and is intended for **gastroenteral use**. The maximum daily dose of acetylsalicylic acid is 160 mg, with a total maximum dose of 60,640 mg over the course of the treatment period, which spans up to 379 days. The active substance is of chemical origin, and the formulation is not specifically designed for pediatric use. The administration schedule is designed to ensure participant compliance, with regular monitoring to ensure adherence to the dosing regimen.

Another experimental medication used in the trial is **ticagrelor**, also provided in tablet form for gastroenteral use. The maximum daily dose for ticagrelor is 180 mg, with a total maximum dose of 68,220 mg over the same treatment period of 379 days. Similar to acetylsalicylic acid, ticagrelor is a chemical-origin active substance and is not formulated for pediatric use. The trial protocol includes measures to monitor participant compliance with the dosing schedule, ensuring that the administration of ticagrelor is consistent with the study requirements.

The trial also includes a comparator treatment, which is the administration of acetylsalicylic acid alone, to evaluate the efficacy of dual antiplatelet therapy with ticagrelor and acetylsalicylic acid versus acetylsalicylic acid monotherapy. The comparator treatment follows the same dosing and administration guidelines as the experimental acetylsalicylic acid treatment, with a focus on monitoring compliance and ensuring accurate data collection throughout the study period.

The efficacy of the clinical trial will be assessed by evaluating the impact of dual antiplatelet therapy (DAPT) with **ticagrelor** and **acetylsalicylic acid** (ASA) compared to ASA alone on major adverse cardiovascular events (MACE) over a 12-month period following isolated Coronary Artery Bypass Grafting (CABG) in patients with Acute Coronary Syndrome (ACS). The primary endpoint for efficacy assessment is a composite endpoint, which includes the time to all-cause death, myocardial infarction, stroke, or new coronary revascularization within 12 months. Secondary endpoints include individual components such as time to all-cause death, myocardial infarction, stroke, cardiovascular death, first myocardial infarction, first stroke, new revascularization, coronary angiography, hospitalization for heart failure, cardiovascular hospitalization, sudden death or aborted cardiac arrest, and new-onset atrial fibrillation (AF).