Evaluation of Ticagrelor Plus Acetylsalicylic Acid Versus Acetylsalicylic Acid Alone on Ischemic Events and Graft Failure in Coronary Artery Bypass Grafting Patients

The primary objective of the study is to compare the effect of **ticagrelor** in addition to **acetylsalicylic acid** (ASA) versus ASA alone for one month on the one-year incidence of ischemic events and graft failure among patients undergoing coronary artery bypass grafting (CABG) for stable ischemic heart disease (SIHD). This is clinically relevant as it aims to determine the potential benefits of adding ticagrelor to standard ASA therapy in reducing the risk of adverse cardiovascular outcomes and improving graft patency in this patient population.

Secondary objectives include determining the net effect of ticagrelor in addition to ASA versus ASA alone for one month on the one-year incidence of ischemic events, graft failure, and major bleeding events. This will provide further insights into the safety and efficacy profile of the combination therapy in comparison to ASA monotherapy.

The clinical trial involves a total of **450 participants** diagnosed with **coronary artery disease**. The study population includes both male and female subjects, with an age range of 18 years and older. Participants were selected based on specific criteria, including undergoing elective first-time coronary artery bypass grafting (CABG) with the use of at least one saphenous vein graft and having chronic coronary disease. All participants are required to have the ability to sign informed consent and comply with study procedures, including a follow-up period of at least five years. The trial does not include a vulnerable population. Lifestyle considerations such as diet, physical activity, or habits are not specified in the available data. The selection process ensures that participants are in a general health status suitable for the study's requirements.

The clinical trial is designed to evaluate the efficacy of **ticagrelor** in combination with **acetylsalicylic acid** (ASA) compared to ASA alone in patients undergoing coronary artery bypass grafting (CABG) for stable ischemic heart disease (SIHD). This is a randomized, double-blind, controlled trial with a primary objective to assess the one-year incidence of ischemic events and graft failure. The trial is expected to commence recruitment on September 1, 2024, and conclude by March 30, 2030. Participants will be randomly assigned to receive either ticagrelor plus ASA or ASA alone, with the treatment period lasting for one month.

The study involves several key visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as age (≥18 years), elective first-time CABG with at least one saphenous vein graft, and the ability to provide informed consent. Follow-up visits will be scheduled to monitor the participants' health status and adherence to the study protocol. The primary endpoint will be evaluated at one year, focusing on a hierarchical composite of time to death, stroke, myocardial infarction, repeat revascularization, and any graft failure. Secondary endpoints include additional assessments at one and five years, incorporating quality of life measures using the Seattle Angina Questionnaire (SAQ-7).

Participant involvement is expected to last for a minimum of one year, with follow-up extending up to five years for certain secondary endpoints. Conditions that may lead to early termination from the study include non-compliance with the study protocol, withdrawal of consent, or any adverse events that compromise participant safety. The trial is classified as a phase 3b study, indicating its advanced stage in the clinical research process. The trial's design ensures rigorous evaluation of the treatment's impact on coronary artery disease outcomes, contributing valuable data to the field of cardiovascular medicine.

The clinical trial involves the administration of several medications, including **Aspirin® protect 100 mg** gastro-resistant tablets, which contain **acetylsalicylic acid** as the active substance. This medication is manufactured by Bayer Vital GmbH and is administered orally. The dosage form is a gastro-resistant tablet, designed to prevent the release of the active substance in the stomach, thereby minimizing gastric irritation. The maximum daily dose is 150 mg, with a total maximum dose of 4500 mg over a treatment period of 30 days.

Another medication used in the trial is **Trombyl 75 mg** tablets, produced by Pfizer AB. These tablets also contain **acetylsalicylic acid** as the active ingredient and are administered orally. The pharmaceutical form is a standard tablet, and the dosing regimen allows for a maximum daily dose of 150 mg, with a total maximum dose of 4500 mg over 30 days.

The trial also includes the use of **Brilique 90 mg** film-coated tablets, which contain **ticagrelor** as the active substance. Manufactured by AstraZeneca AB, these tablets are administered orally. The film-coated formulation is designed to facilitate swallowing and improve patient compliance. The maximum daily dose for Brilique is 180 mg, with a total maximum dose of 5400 mg over the 30-day treatment period.

Additionally, **Thrombo ASS 100 mg** gastro-resistant tablets are included in the study. These tablets, produced by G.L. Pharma GmbH, contain **acetylsalicylic acid** and are administered orally. Similar to Aspirin® protect, the gastro-resistant formulation is intended to reduce gastric side effects. The dosing schedule permits a maximum daily dose of 150 mg, with a total maximum dose of 4500 mg over the course of 30 days.

All medications are administered orally, and participant compliance is monitored throughout the trial to ensure adherence to the dosing schedules. The trial aims to evaluate the effects of ticagrelor in combination with acetylsalicylic acid versus acetylsalicylic acid alone in patients undergoing coronary artery bypass grafting for stable ischemic heart disease.

Efficacy in the clinical trial titled "The One-Month DAPT with Ticagrelor In CABG PatieNts Trial (ODIN)" will be assessed using a hierarchical composite of clinical endpoints. The primary endpoint is the time to death, stroke, myocardial infarction, repeat revascularization, and any graft failure, evaluated at one year. Secondary endpoints include similar composites with additional parameters such as Bleeding Academic Research Consortium (BARC) type 3 bleeding and a 5-year time-averaged disease-specific quality of life score using the Seattle Angina Questionnaire (SAQ-7), assessed at both one and five years.

The efficacy parameters will be measured and collected at specified timepoints, including one year and five years post-treatment. The analysis will involve validated scales and clinical assessments to ensure accurate and reliable data collection. The trial aims to compare the effect of **ticagrelor** in addition to acetylsalicylic acid (ASA) versus ASA alone on the incidence of ischemic events and graft failure among patients undergoing coronary artery bypass grafting (CABG) for stable ischemic heart disease (SIHD).