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


- candidate number3187
- NTR NumberNTR1273
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-apr-2008
- Secondary IDsASSIGN 
- Public TitleAspirin sensitivity in diabetes mellitus; the role of glycaemic control and dosing
- Scientific TitleAspirin sensitivity in diabetes mellitus; the role of glycaemic control and dosing
- ACRONYMASSIGN
- hypothesisAspirin (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.
- Healt Condition(s) or Problem(s) studiedCardiovascular disease, Diabetes Mellitus, Aspirin
- Inclusion criteria1. Age > 18 years
2. Diagnosis of type 2 diabetes
- Exclusion criteria1. 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-mei-2008
- planned closingdate1-mei-2009
- Target number of participants140
- InterventionsAll 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
- Primary outcomeThe primary outcome of this study is the prevalence of laboratory measured aspirin resistance stratified by level of glycaemic control
- Secondary outcomeThe secondary outcome is the ability of increased dosing to overcome laboratory measured aspirin resistance in type 2 diabetes mellitus.
- TimepointsT=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.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES B.A. Lemkes
- CONTACT for SCIENTIFIC QUERIESDr. F. Holleman
- Sponsor/Initiator Academic Medical Center (AMC), Department of Internal Medicine
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryAspirin (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.
- Main changes (audit trail)
- RECORD11-apr-2008 - 17-apr-2008


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