No registrations found.
ID
Source
Brief title
Health condition
Diabetes mellitus
Cardiovascular disease
Sponsors and support
Dept. of Internal Medicine
Academic Medical Centre
Intervention
Outcome measures
Primary outcome
The primary outcome of this study is the prevalence of laboratory measured aspirin resistance stratified by level of glycaemic control
Secondary outcome
The secondary outcome is the ability of increased dosing to overcome laboratory measured aspirin resistance in type 2 diabetes mellitus.
Background summary
Aspirin (acetylsalicylic acid) is the cornerstone of primary and secondary cardiovascular disease prevention, but its preventive effects are reduced in the presence of diabetes mellitus. Whether hyperglycaemia plays an important role in the reduced anti-aggregating effects of acetylsalicylic acid in diabetes remains unclear. The main objective of this study is to determine the role of glycaemic control in diabetes mellitus in the occurrence of acetylsalicylic acid resistance, the secondary objective is to determine the effect of increased dosing on acetylsalicylic acid resistance in diabetes mellitus.
To this end 105 patients with type 2 diabetes will be assigned to increasing doses of aspirin, during which the laboratory measured platelet response will be determined. Also, 35 healthy volunteers will undergo the same treatment.
Study objective
Aspirin (acetylsalicylic acid) is the cornerstone of primary and secondary cardiovascular disease prevention, but its preventive effects are reduced in the presence of diabetes mellitus. Whether hyperglycaemia plays an important role in the reduced anti-aggregating effects of acetylsalicylic acid in diabetes remains unclear. The main objective of this study is to determine the role of glycaemic control in diabetes mellitus in the occurrence of acetylsalicylic acid resistance, the secondary objective is to determine the effect of increased dosing on acetylsalicylic acid resistance in diabetes mellitus.
Study design
T=0 (baseline): platelet aggregationtests + thromboxane measurements + start study medication (aspirin 30 mg daily)
T= 10: repeat platelet aggregationtests + thromboxane measurements + start aspirin 100 mg daily
T= 20: repeat platelet aggregationtests + thromboxane measurements + start aspirin 300 mg daily
T= 30: repeat platelet aggregationtests + thromboxane measurements_ End of study.
Intervention
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
Academic Medical Centre
B.A. Lemkes
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5663637
b.a.lemkes@amc.uva.nl
Academic Medical Centre
B.A. Lemkes
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5663637
b.a.lemkes@amc.uva.nl
Inclusion criteria
1. Age > 18 years
2. Diagnosis of type 2 diabetes
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1228 |
| NTR-old | NTR1273 |
| Other | : ASSIGN |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |