PLatelet aggregation and Aspirin low response in Type One Diabetes and the association with vascular damage and diabetic Nephropathy

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Steno Diabetes Center Copenhagen

Participant type

Healthy volunteers, Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Hormonal diseases [C19], Diseases [C] - Cardiovascular Diseases [C14]

Decision date (initial)

2025-01-22

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-520324-29-00

EudraCT number

2019-004772-19

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic

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.

Secondary objectives 7

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 greyscale.
4. Examine the association between platelet aggregation and the plaque volume in the carotid arteries in subjects with T1D.
5. Investigate whether platelet aggregation or plaque volume can predict progression in plaque volume after two years, independently of other risk factors.
6. Investigate if platelet aggregation and change in plaque volume can predict CVD outcome in register-based follow up, independently of other risk factors.
7. Investigate endothelial function and inflammation in T1D and examine the association with platelet aggregation and plaque volume in the carotid arteries.

Conditions and MedDRA coding

Atherosclerotic cardiovascular disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Type 1 diabetes. (Only for the type 1 diabetes population.)
2. Male and female participants > 18 years of age.
3. Capable of giving informed consent

Exclusion criteria 10

1. Pregnancy or breastfeeding
2. Persons who, in the judgement of the investigator, are incapable of participating.
3. Participation in another intervention study
4. Non-diabetic kidney disease. (Only the type 1 diabetes population.)
5. 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.
6. 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.)
7. 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.)
8. Known hypersensitivity or intolerance to aspirin. (Only the type 1 diabetes population.)
9. Chronic systemic disease. (Only healthy controls.)
10. Intake of any antithrombotic medication or fish oil, or intake of NSAIDs within the past 14 days. (Only healthy controls.)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 7

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 the plaque volume in the carotid arteries in subjects with T1D.
4. Examine the association between platelet aggregation and the plaque volume in the carotid arteries in subjects with T1D.
5. Investigate whether platelet aggregation or plaque volume can predict progression in plaque volume after two years, independently of other risk factors.
6. Investigate if platelet aggregation and change in plaque volume can predict CVD outcome in register-based follow up, independently of other risk factors.
7. Investigate endothelial function and inflammation in T1D and examine the association with platelet aggregation and plaque volume in the carotid arteries.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Steno Diabetes Center Copenhagen

Sponsor organisation

Steno Diabetes Center Copenhagen

Address

Borgmester Ib Juuls Vej 83

City

Herlev

Postcode

2730

Country

Denmark

Scientific contact point

Organisation

Steno Diabetes Center Copenhagen

Contact name

Peter Rossing

Public contact point

Organisation

Steno Diabetes Center Copenhagen

Contact name

Peter Rossing

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications