The effect of aspirin on platelets and blood vessels in healthy persons and patients with the disease type 2 diabetes.

Antiplatelet and vascular effects of aspirin in healthy persons and patients with type 2 diabetes.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000515-32-DK

Enrollment

Unknown

Registered

2016-02-29

Start date

2016-04-12

Completion date

Unknown

Last updated

2017-03-13

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

Conditions

Type 2 diabetes and Healthy volunteers MedDRA version: 18.1 Level: LLT Classification code 10012594 Term: Diabetes System Organ Class: 100000004861

Interventions

Trade Name: Hjertemagnyl, filmovertrukne tabletter 75 mg Pharmaceutical Form: Coated tablet INN or Proposed INN: Acetylsalisylsyre Other descriptive name: ACETYLSALICYLIC ACID Concentration unit: mg m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Diabetics: Age > 18 years and a diagnosis of type 2 diabetes. Controls: age > 18 years and exclusion of type 2 diabetes by oral glucose tolerance test. 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 21 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 21

Exclusion criteria

Exclusion criteria: Current treatment with antiplatelet drugs or anticoagulants including aspirin. Treatment with non-steroidal antiinflammatory drugs. Aspirin hypersensitivity. Pregnancy. Gastrointestinal bleeding within the last month. Platelet disease and/or bleeding diseases. Low platelet count (< 120 x 109/L). Active cancer diagnose, chronic or acute infection, dialysis. Known Cardiovascular disease. Inability to give informed consent.

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim is to investigate the effect of aspirin on platelet aggregation, endothelial-dependent vasodilation and arterial stiffness during 24 hours in patients with type 2 diabetes without known cardiovascular disease and in healthy controls.;Secondary Objective: Not applicable;Primary end point(s): 24-hour antiplatelet effects of aspirin (maintenance therapy): To investigate the effect of aspirin on platelet aggregation early and late in the 24-hour dosing interval in patients with type 2 diabetes and healthy controls receiving aspirin as maintenance therapy. ;Timepoint(s) of evaluation of this end point: At the end of the trial.	—

Measure

Time frame

Main Objective: The aim is to investigate the effect of aspirin on platelet aggregation, endothelial-dependent vasodilation and arterial stiffness during 24 hours in patients with type 2 diabetes without known cardiovascular disease and in healthy controls.;Secondary Objective: Not applicable;Primary end point(s): 24-hour antiplatelet effects of aspirin (maintenance therapy): To investigate the effect of aspirin on platelet aggregation early and late in the 24-hour dosing interval in patients with type 2 diabetes and healthy controls receiving aspirin as maintenance therapy. ;Timepoint(s) of evaluation of this end point: At the end of the trial.

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Secondary

Measure	Time frame
Secondary end point(s): 24-hour vascular effects of aspirin (maintenance therapy): To investigate the effect of aspirin on endothelial-dependent vasodilation and arterial stiffness early and late in the 24-hour dosing interval in patients with type 2 diabetes and healthy controls receiving aspirin as maintenance therapy. Acute effects of aspirin (aspirin-naïve): To investigate the acute effect of aspirin on platelet aggregation, endothelial-dependent vasodilation and arterial stiffness in aspirin-naïve patients with type 2 diabetes and healthy controls. 24 hour platelet turnover: To investigate platelet turnover early and late in the 24-hour dosing interval of aspirin in patients with type 2 diabetes and healthy controls. ;Timepoint(s) of evaluation of this end point: At the end of the trial.	—

Measure

Time frame

Secondary end point(s): 24-hour vascular effects of aspirin (maintenance therapy): To investigate the effect of aspirin on endothelial-dependent vasodilation and arterial stiffness early and late in the 24-hour dosing interval in patients with type 2 diabetes and healthy controls receiving aspirin as maintenance therapy. Acute effects of aspirin (aspirin-naïve): To investigate the acute effect of aspirin on platelet aggregation, endothelial-dependent vasodilation and arterial stiffness in aspirin-naïve patients with type 2 diabetes and healthy controls. 24 hour platelet turnover: To investigate platelet turnover early and late in the 24-hour dosing interval of aspirin in patients with type 2 diabetes and healthy controls. ;Timepoint(s) of evaluation of this end point: At the end of the trial.

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Countries

Denmark

Contacts

Public ContactCoordinator

Liv Vernstrøm Hald

lvh@clin.au.dk

Outcome results

None listed

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