Evaluation of Aspirin Omission on Bleeding and Ischemic Outcomes in Non-ST-Segment Elevation Acute Coronary Syndrome Patients

The primary objective of this study is to evaluate whether omitting **aspirin** reduces the incidence of major or minor bleeding in patients with **non-ST-segment elevation acute coronary syndrome** while maintaining non-inferiority in terms of ischemic events compared to the current standard of care. This is clinically relevant as it aims to optimize treatment strategies by potentially minimizing bleeding risks without compromising the efficacy of ischemic event prevention in this patient population.

The clinical trial involves participants diagnosed with **non-ST-segment elevation acute coronary syndrome** (NSTE-ACS), including conditions such as NSTEMI or unstable angina. The study population comprises both male and female subjects, with an age range that includes adults and older adults. Participants are required to have undergone a successful percutaneous coronary intervention (PCI) as determined by the treating physician. The trial does not include vulnerable populations. The sponsor has not provided information regarding the total number of participants. Lifestyle factors such as diet, physical activity, or habits are not specified in the available data.

The clinical trial is designed to evaluate the impact of omitting **aspirin** on bleeding rates while maintaining non-inferiority in ischemic events for patients with **non-ST-segment elevation acute coronary syndrome** (NSTE-ACS). This is a Phase IV, randomized, double-blind, controlled trial. The trial is expected to run from May 2022 to August 2027, with a maximum treatment period of 12 months for each participant. The study will involve the administration of **acetylsalicylic acid** in the form of dispersible tablets, with a maximum daily dose of 100 mg and a total dose not exceeding 37,200 mg over the treatment period.

Participants will undergo a series of study visits, beginning with an inclusion visit where eligibility is confirmed based on criteria such as a clinical diagnosis of NSTE-ACS and successful percutaneous coronary intervention (PCI). Follow-up visits will be scheduled to monitor the primary endpoints, which include the incidence of major or minor bleeding as defined by the Bleeding Academic Research Consortium (BARC) and a composite of all-cause mortality, myocardial infarction, and stroke at 12 months. The end-of-study visit will conclude the participant's involvement, assessing the overall outcomes and any adverse events.

Participant involvement is expected to last up to 12 months, with conditions for early termination including withdrawal of consent, significant protocol deviations, or adverse events that compromise safety. The trial aims to provide valuable insights into the management of NSTE-ACS, potentially influencing future treatment guidelines.

The clinical trial involves the administration of **acetylsalicylic acid** as the experimental medication. The product used is "Acetylsalicylzuur Cardio Aurobindo 80 mg, dispergeerbare tabletten," which is a **dispersible tablet** formulation. Each tablet contains 80 mg of the active substance, **acetylsalicylic acid**, and is intended for oral administration. The maximum daily dose is set at 100 mg, with a total maximum dose of 37,200 mg over the course of the study. The treatment period is limited to a maximum of 12 months. The medication is manufactured by Aurobindo Pharma B.V. and is not a pediatric formulation. The chemical origin of the active substance is confirmed, and the product is authorized for use in the Netherlands.

In this study, the experimental treatment is compared against the current standard-of-care therapy for patients with non-ST segment elevation acute coronary syndrome. The trial aims to evaluate whether omitting aspirin can reduce the rate of major or minor bleeding while maintaining non-inferiority in terms of ischemic events. No additional non-experimental treatments, such as placebo or other comparator treatments, are specified in the trial data. Compliance with the dosing schedule will be monitored throughout the study to ensure adherence to the prescribed regimen.

The efficacy of the clinical trial titled "Less Bleeding by Omitting Aspirin in Non-ST-segment Elevation Acute Coronary Syndrome Patients" will be assessed using specific primary endpoints. These endpoints include the incidence of major or minor bleeding, defined according to the Bleeding Academic Research Consortium (BARC) criteria as type 2, 3, or 5 bleeding, and the composite of all-cause mortality, myocardial infarction, and stroke. Both primary endpoints will be evaluated at 12 months following the intervention.

The trial aims to determine if omitting aspirin can reduce bleeding rates while maintaining non-inferiority in terms of ischemic events compared to the current standard of care in patients with **non-ST segment elevation acute coronary syndrome** (NSTE-ACS). The assessment of these endpoints will involve the collection and analysis of clinical data over a 12-month period, ensuring a comprehensive evaluation of the treatment's efficacy in achieving the trial's objectives.