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…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Diabetic complications
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the prevalence of laboratory acetylsalicylic acid
resistance in patients stratified by level of glycaemic control.
Secondary outcome
The secondary endpoint is the ability of increased dosing to overcome
hyperglycaemia-associated acetylsalicylic acid resistance.
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.
Study objective
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
Diagnostic, non-randomized, open label, pharmacodynamics study
Intervention
All included subjects will be assigned to increasing doses of acetylsalicylic
acid. The dosing will start at 30 mg of acetylsalicylic acid daily for ten
days, followed by 100 mg of acetylsalicylic acid for ten days, after which the
dose will increase to 300 mg of acetylsalicylic acid daily for ten days.
Study burden and risks
Included subjects will visit the AMC hospital on five different occasions:
Visit 1: Screenings visit, informed consent, medical history, vital signs
Visit 2: Baseline laboratory measurements, start study medication
Visit 3: Laboratory measurements, start second dosing schedule of study
medication
Visit 4: Laboratory measurements, start third dosing schedule of study
medication
Visit 5: Laboratory measurements, end of study
At visit 2-5 subjects will be asked to come to the laboratory in a fasting
state and approximately 52.5 ml of blood will be drawn each visit.
This study will provide new insight on the effect of acetyl salicylic acid
therapy on platelets in the diabetic patient, elucidating the role of glycaemic
control and the possibility of increased dosing to establish the desired
platelet inhibitory effect. This insight is needed to determine the optimal
strategy of cardiovascular disease prevention in diabetic patients, a group of
patients at high risk of developing this complication.
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Age > 18 years
Diagnosis of type 2 diabetes according to ADA criteria
Exclusion criteria
Current acetylsalicylic acid therapy
Use of any medication interfering with platelet function, e.g. diclofenac, naproxen or clopidogrel
Allergy or hypersensitivity to prostaglandinsynthetase inhibitors
Hemorrhagic stroke in medical history
Gastric complaints or gastritis/ulcus pepticum
Severe liver or kidneyfailure
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2008-001308-22-NL |
| CCMO | NL22347.018.08 |