acetylsalicylic acid for Atherosclerotic cardiovascular disease | Type 1 diabetes | Diabetic kidney disease

Stratification factors

• degree of albuminuria

Inclusion criteria

• {"criterion_text":"- Type 1 diabetes. (Only for the type 1 diabetes population.)"}
• {"criterion_text":"- Male and female participants > 18 years of age."}
• {"criterion_text":"- Capable of giving informed consent"}

Exclusion criteria

• {"criterion_text":"- Pregnancy or breastfeeding"}
• {"criterion_text":"- Intake of any antithrombotic medication or fish oil, or intake of NSAIDs within the past 14 days. (Only healthy controls.)"}
• {"criterion_text":"- Persons who, in the judgement of the investigator, are incapable of participating."}
• {"criterion_text":"- Participation in another intervention study"}
• {"criterion_text":"- Non-diabetic kidney disease. (Only the type 1 diabetes population.)"}
• {"criterion_text":"- Treatment with adenosine diphosphate ADP-receptor inhibitors, NSAID within the past 14 days, fish oil or other antithrombotic treatment, e.g. vitamin K antagonists and NOAKs. Only the type 1 diabetes population."}
• {"criterion_text":"- Liver disease (liver cirrhosis with current impaired liver function defined as ALAT more than two times the upper limit at last control.) (Only the type 1 diabetes population.)"}
• {"criterion_text":"- High risk of thrombosis, i.e., Stroke, TIA or drug eluting stent within the last 6 months or acute coronary syndrome within the last 6 weeks or within 12 months from complications to acute coronary syndrome. (Only the type 1 diabetes population.)"}
• {"criterion_text":"- Known hypersensitivity or intolerance to aspirin. (Only the type 1 diabetes population.)"}
• {"criterion_text":"- Chronic systemic disease. (Only healthy controls.)"}

Primary endpoints

• {"endpoint_text":"- Investigate platelet aggregation in T1D without/off aspirin treatment, stratified according to degree of albuminuria, compared to healthy controls. Platelet aggregation is determined by arachidonic acid expressed as area under the curve.","definition_or_measurement_approach":"Platelet aggregation is determined by arachidonic acid expressed as area under the curve."}

Secondary endpoints

• {"endpoint_text":"- Investigate platelet aggregation after a minimum of seven days aspirin treatment in T1D, stratified according to degree of albuminuria, compared to healthy controls.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Determine the prevalence of plaques and plaque volume in the carotid arteries in subjects with T1D.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Examine the association between platelet aggregation and plaque morphology, expressed as a greyscale.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Examine the association between platelet aggregation and the plaque volume in the carotid arteries in subjects with T1D.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Investigate whether platelet aggregation or plaque volume can predict progression in plaque volume after two years, independently of other risk factors.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Investigate if platelet aggregation and change in plaque volume can predict CVD outcome in register-based follow up, independently of other risk factors.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Investigate endothelial function and inflammation in T1D and examine the association with platelet aggregation and plaque volume in the carotid arteries.","definition_or_measurement_approach":""}

Denmark

Earliest CTIS Part Ii Submission Date

13-01-2025

Latest Decision Or Authorization Date

22-01-2025

Processing Time Days

9

Number Of Sites

1

Number Of Participants

332

Primary sponsor

Full Name

Steno Diabetes Center Copenhagen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"code 1","organisation_type":"Hospital/Clinic/Other health care facility"}