Evaluation of Platelet Aggregation and Acetylsalicylic Acid Response in Type 1 Diabetes Patients with Atherosclerotic Cardiovascular and Diabetic Kidney Disease

The primary objective of this study is to **investigate platelet aggregation** in individuals with **Type 1 Diabetes (T1D)** who are not undergoing or have ceased aspirin treatment. This investigation is stratified according to the degree of albuminuria and compared to healthy controls. The clinical relevance of this objective lies in understanding the role of platelet aggregation in the context of T1D, which is crucial for managing potential complications such as **atherosclerotic cardiovascular disease** and **diabetic kidney disease**.

Secondary objectives include:

• Investigating platelet aggregation after a minimum of seven days of aspirin treatment in T1D, stratified by albuminuria, compared to healthy controls.
• Determining the prevalence of plaques and plaque volume in the carotid arteries in subjects with T1D.
• Examining the association between platelet aggregation and plaque morphology, expressed as a greyscale.
• Examining the association between platelet aggregation and plaque volume in the carotid arteries in subjects with T1D.
• Investigating whether platelet aggregation or plaque volume can predict progression in plaque volume after two years, independently of other risk factors.
• Investigating if platelet aggregation and change in plaque volume can predict cardiovascular disease outcomes in register-based follow-up, independently of other risk factors.
• Investigating endothelial function and inflammation in T1D and examining the association with platelet aggregation and plaque volume in the carotid arteries.

The clinical trial involves participants diagnosed with **Type 1 diabetes**, **atherosclerotic cardiovascular disease**, and **diabetic kidney disease**. The study population includes both male and female subjects over the age of 18, who are capable of providing informed consent. The trial does not involve 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 study does not specify any particular lifestyle considerations such as diet or physical activity. The trial aims to investigate platelet aggregation in individuals with Type 1 diabetes, stratified by the degree of albuminuria, compared to healthy controls. The sponsor has not disclosed additional details about the selection process or specific lifestyle factors.

The clinical trial is designed to investigate **platelet aggregation** in individuals with **Type 1 diabetes** (T1D) without or off aspirin treatment, stratified according to the degree of albuminuria, and compared to healthy controls. This study is a Phase 4, randomized, double-blind, controlled trial, utilizing **acetylsalicylic acid** as the investigational product, administered as an oral solution. The trial aims to assess the primary endpoint of platelet aggregation determined by arachidonic acid expressed as the area under the curve. Secondary endpoints include evaluating platelet aggregation after a minimum of seven days of aspirin treatment, determining the prevalence of plaques in the carotid arteries, and examining associations between platelet aggregation and plaque volume.

The trial is expected to run from May 12, 2020, to December 31, 2030. Participants will be involved for a maximum treatment period of 28 days, with a daily dose of 75 mg of acetylsalicylic acid. The study includes several key visits: an initial screening visit to confirm eligibility based on inclusion criteria such as being over 18 years of age and having T1D, followed by regular follow-up visits to monitor treatment effects and safety. The end-of-study visit will conclude the participant's involvement, assessing the final outcomes and any adverse events.

Participants may be withdrawn from the study if they experience significant adverse effects, fail to comply with the study protocol, or withdraw consent. The trial's design ensures rigorous monitoring and data collection to achieve its objectives while maintaining participant safety and data integrity.

The clinical trial involves the administration of **acetylsalicylic acid** as the experimental medication. This compound is provided in the form of an **oral solution**. The active substance, **acetylsalicylic acid**, is of chemical origin and is administered orally. The dosage is set at a maximum of 75 mg per day, with the total daily dose not exceeding this amount. The treatment period is limited to a maximum of 28 days. The primary role of this medication in the trial is to act as a platelet aggregation inhibitor, excluding heparin. The trial aims to investigate platelet aggregation in individuals with Type 1 Diabetes (T1D) who are not currently receiving aspirin treatment, with a focus on the degree of albuminuria and its association with vascular damage and diabetic nephropathy.

Efficacy in this clinical trial will be assessed by evaluating **platelet aggregation** in individuals with Type 1 Diabetes (T1D) both without and after a minimum of seven days of aspirin treatment. The primary endpoint involves measuring platelet aggregation in T1D patients without aspirin treatment, stratified by the degree of albuminuria, and comparing it to healthy controls. This will be quantified using arachidonic acid expressed as the area under the curve. Secondary endpoints include assessing platelet aggregation after aspirin treatment, determining the prevalence and volume of plaques in the carotid arteries, and examining the association between platelet aggregation and plaque volume. Additionally, the study will investigate whether platelet aggregation or plaque volume can predict progression in plaque volume and cardiovascular disease (CVD) outcomes, independently of other risk factors. The trial will also explore endothelial function and inflammation in T1D and their association with platelet aggregation and plaque volume. The trial is designed as a Phase 4 mechanistic study using already approved medication, with an estimated end date of December 31, 2030.