Platelet aggregation and aspirin low response in type one diabetes and the association with vascular damage and diabetic kidney disease

Platelet aggregation and aspirin low response in type one diabetes and the association with vascular damage and diabetic nephropathy - PLATON

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004772-19-DK

Enrollment

360

Registered

2020-01-16

Start date

2020-04-08

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of cardiovascular disease in persons with type 1 diabetes

Interventions

Trade Name: Hjertemagnyl Pharmaceutical Form: Coated tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria (T1D) • Type 1 diabetes • Male and female participants, >18 years of age • Capable of giving informed consent Inclusion criteria (healthy controls) • Healthy, as judged by the exclusion criteria’s below • Male and female participants, >18 years of age • Capable of giving informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: Exclusion criteria (T1D) • Pregnancy or breastfeeding (urine HCG is performed on all fertile women) • Non-diabetic kidney disease • Treatment with adenosine diphosphate (ADP)-receptor inhibitors, NSAID within the past 14 days, fish oil or other antithrombotic treatment (vitamin K antagonists and NOAKs) • Liver disease (liver cirrhosis with current impaired liver function defined as alanine-aminotransferase (ALT) more than two times the upper limit at last control) • High risk of thrombosis: o Stroke, TIA or drug eluting stent within the last 6 months o Acute coronary syndrome within the last 6 weeks or within 12 months from complications to acute coronary syndrome • Known hypersensitivity or intolerance to aspirin • Persons who, in the judgement of the investigator, are incapable of participating. • Participation in another intervention study Exclusion criteria (healthy controls) • Chronic systemic disease • Intake of any antithrombotic medication • Intake of fish oil • Intake of NSAIDs within the past 14 days • Pregnancy or breastfeeding (urine HCG is performed in all fertile women) • Persons who, in the judgement of the investigator, are incapable of participating • Participation in another intervention study

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective is to investigate platelet aggregation in type 1 diabetes (T1D) without/off aspirin treatment, stratified according to degree of albuminuria, compared to healthy controls;Secondary Objective: •Investigate platelet aggregation after a minimum of seven days aspirin treatment in T1D, stratified according to degree of albuminuria, compared to healthy controls. •Determine the prevalence of plaques and plaque volume in the carotid arteries in subjects with T1D. •Examine the association between platelet aggregation and plaque morphology (expressed as a grayscale) •Examine the association between platelet aggregation and the plaque volume in the carotid arteries in subjects with T1D. •Investigate whether platelet aggregation or plaque volume can predict progression in plaque volume after two years, independently of other risk factors. •Investigate if platelet aggregation and change in plaque volume can predict CVD outcome in register-based follow up, independently of other risk factors. •Investigate endothelial function and inflammation in T1D and examine the association with platelet aggregation and plaque volume in the carotid arteries. ;Primary end point(s): •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. ;Timepoint(s) of evaluation of this end point: The primary endpoint will be evaluated when all participants have attended visit 2 or 3A.	—

Measure

Time frame

Main Objective: The main objective is to investigate platelet aggregation in type 1 diabetes (T1D) without/off aspirin treatment, stratified according to degree of albuminuria, compared to healthy controls;Secondary Objective: •Investigate platelet aggregation after a minimum of seven days aspirin treatment in T1D, stratified according to degree of albuminuria, compared to healthy controls. •Determine the prevalence of plaques and plaque volume in the carotid arteries in subjects with T1D. •Examine the association between platelet aggregation and plaque morphology (expressed as a grayscale) •Examine the association between platelet aggregation and the plaque volume in the carotid arteries in subjects with T1D. •Investigate whether platelet aggregation or plaque volume can predict progression in plaque volume after two years, independently of other risk factors. •Investigate if platelet aggregation and change in plaque volume can predict CVD outcome in register-based follow up, independently of other risk factors. •Investigate endothelial function and inflammation in T1D and examine the association with platelet aggregation and plaque volume in the carotid arteries. ;Primary end point(s): •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. ;Timepoint(s) of evaluation of this end point: The primary endpoint will be evaluated when all participants have attended visit 2 or 3A.

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Secondary

Measure	Time frame
Secondary end point(s): 1 Investigate platelet aggregation after a minimum of seven days aspirin treatment in T1D, stratified according to degree of albuminuria, compared to healthy controls. 2 Determine the prevalence of plaques and plaque volume in the carotid arteries in subjects with T1D. 3 Examine the association between platelet aggregation and plaque morphology (expressed as a grayscale) 4 Examine the association between platelet aggregation and the plaque volume in the carotid arteries in subjects with T1D. 5 Investigate endothelial function and inflammation in T1D and examine the association with platelet aggregation and plaque volume in the carotid arteries. 6 Investigate whether platelet aggregation can predict progression in plaque volume after two years, independently of other risk factors. 7 Investigate if platelet aggregation and change in plaque volume can predict CVD outcome in register-based follow up, independently of other risk factors.;Timepoint(s) of evaluation of this end point: The secondary endpoints no. 1-5 will be evaluated when all participants have attended visit 2 or 3A. The secondary endpoint no. 6 will be evaluated after all participants have attended the 2 year follow-up visit. The secondary endpoint no. 7 will be evaluated after the long-term follow-up data fra registries have been collected.	—

Measure

Time frame

Secondary end point(s): 1 Investigate platelet aggregation after a minimum of seven days aspirin treatment in T1D, stratified according to degree of albuminuria, compared to healthy controls. 2 Determine the prevalence of plaques and plaque volume in the carotid arteries in subjects with T1D. 3 Examine the association between platelet aggregation and plaque morphology (expressed as a grayscale) 4 Examine the association between platelet aggregation and the plaque volume in the carotid arteries in subjects with T1D. 5 Investigate endothelial function and inflammation in T1D and examine the association with platelet aggregation and plaque volume in the carotid arteries. 6 Investigate whether platelet aggregation can predict progression in plaque volume after two years, independently of other risk factors. 7 Investigate if platelet aggregation and change in plaque volume can predict CVD outcome in register-based follow up, independently of other risk factors.;Timepoint(s) of evaluation of this end point: The secondary endpoints no. 1-5 will be evaluated when all participants have attended visit 2 or 3A. The secondary endpoint no. 6 will be evaluated after all participants have attended the 2 year follow-up visit. The secondary endpoint no. 7 will be evaluated after the long-term follow-up data fra registries have been collected.

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Countries

Denmark

Contacts

Public ContactClinical Trials Information

Steno Diabetes Center Copenhagen

peter.rossing@regionh.dk004530913383

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026