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…
ID
Bron
Verkorte titel
Aandoening
Diabetes mellitus
Cardiovascular disease
Ondersteuning
Dept. of Internal Medicine
Academic Medical Centre
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome of this study is the prevalence of laboratory measured aspirin resistance stratified by level of glycaemic control
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
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.
Onderzoeksproduct en/of interventie
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
Algemeen / deelnemers
Academic Medical Centre
B.A. Lemkes
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5663637
b.a.lemkes@amc.uva.nl
Wetenschappers
Academic Medical Centre
B.A. Lemkes
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5663637
b.a.lemkes@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Age > 18 years
2. Diagnosis of type 2 diabetes
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
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