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Aspirin sensitivity in diabetes mellitus; the role of glycaemic control and dosing

Aspirin sensitivity in diabetes mellitus; the role of glycaemic control and dosing

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26330
Enrollment
140
Registered
2008-04-11
Start date
2008-05-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Diabetes mellitus Cardiovascular disease

Interventions

All included subjects will receive three dosingregimens of aspirin treatment
starting at 30 mg per day for ten days, followed by 100 mg per day for ten days and finally 300 mg per day for ten days

Sponsors

Prof. dr. J.B.L. Hoekstra Dept. of Internal Medicine Academic Medical Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age > 18 years 2. Diagnosis of type 2 diabetes

Exclusion criteria

Exclusion criteria: 1. Current acetylsalicylic acid therapy 2. Use of any medication interfering with platelet function, e.g. diclofenac, naproxen or clopidogrel in the two weeks prior to the study. 3. Abnormal platelet count, < 100.000/ mm3 4. Allergy or hypersensitivity to prostaglandinsynthetase inhibitors 5. Hemorrhagic stroke in medical history 6. Gastric complaints or gastritis/ulcus pepticum, history of gastric bleeding 7. Known coagulation disorders 8. Severe liver or kidneyfailure 9. Substance abuse

Design outcomes

Primary

MeasureTime frame
The primary outcome of this study is the prevalence of laboratory measured aspirin resistance stratified by level of glycaemic control

Secondary

MeasureTime frame
The secondary outcome is the ability of increased dosing to overcome laboratory measured aspirin resistance in type 2 diabetes mellitus.

Contacts

Public ContactB.A. Lemkes

Dept. of Internal Medicine, Academic Medical Centre

b.a.lemkes@amc.uva.nl+31 (0)20 5663637

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)