2024-520324-29-00Not yet recruitingPhase 2
PLatelet aggregation and Aspirin low response in Type One Diabetes and the association with vascular damage and diabetic Nephropathy
Source: EU CTIS (euclinicaltrials.eu) · Last updated 22 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 332 (estimated)
- First submitted
- 18 Dec 2024
- Start date
- 12 May 2020
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Diseases
- Chronic kidney disease
- EU CT number
- 2024-520324-29-00
- EudraCT number
- 2019-004772-19
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 332
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with type 1 diabetes, and also healthy adults as a comparison group, to study how blood platelets clump together with and without aspirin.
- Age
- Over 18 years
- Sex
- All sexes
- Disease stage
- Type 1 diabetes (for the diabetes group). The record also mentions groups by amount of albumin in the urine.
- Earlier treatment
- People with type 1 diabetes cannot have had treatment with ADP-receptor inhibitors, NSAIDs within the past 14 days, fish oil or other blood-thinning treatment. Healthy controls cannot have taken any blood-thinning medicine or fish oil, or NSAIDs within the past 14 days.
Main reasons for not taking part
- Pregnancy or breastfeeding
- Taking part in another intervention study
- Kidney disease not caused by diabetes (diabetes group)
- Liver disease with impaired liver function (diabetes group)
- High risk of blood clots, such as recent stroke, TIA, drug-eluting stent or acute coronary syndrome (diabetes group)
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Intake of any antithrombotic medication or fish oil, or intake of NSAIDs within the past 14 days. (Only healthy controls.)
- 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.
Other illness
- Non-diabetic kidney disease. (Only the type 1 diabetes population.)
- 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.)
- 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.)
- Known hypersensitivity or intolerance to aspirin. (Only the type 1 diabetes population.)
- Chronic systemic disease. (Only healthy controls.)
Other
- Pregnancy or breastfeeding
- Persons who, in the judgement of the investigator, are incapable of participating.
- Participation in another intervention study
Who the study is looking for
- Type 1 diabetes. (Only for the type 1 diabetes population.)
- Male and female participants > 18 years of age.
- Capable of giving informed consent
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Steno Diabetes Center Copenhagen | Herlev | Denmark | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.