The objective of the study is to gain new insights in the causes of a higher clopidogrel resistence in type II diabetes mellitus patients
ID
Source
Brief title
Condition
- Platelet disorders
- Diabetic complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
[1] ADP and collagen stimulated Ca2+ mobilization of platelets
[2] ADP and collagen stimulated P-selectin expression on platelets
Secondary outcome
NVT
Background summary
Diabetes mellitus patients suffer from an absolute or relative defect in
insulin function or secretion. They have an increased risk on the development
of cardiovascular diseases compared to healthy persons. Besides changes in the
vascular wall, they also have hypersensitive platelets, leading to pathologic
vessel occlusions, after a small stimulus. The platelets of type II diabetes
mellitus patients are more resistent to clopidogrel than non diabetic patients.
This is associated with atherothrombotic events.
Study objective
The objective of the study is to gain new insights in the causes of a higher
clopidogrel resistence in type II diabetes mellitus patients
Study design
Observation study
Intervention
clopidogrel 75 mg per dag for one week
Study burden and risks
60 ml of blood is withdrawn from participating persons twice. Between the
first and second blood withdrawal the subjects take clopidogrel for one week.
Clopidogrel can cause side-effects. With this blood two platelet functional
assays are performed, which can contribute to the knowledge on clopidogrel
resistence in type II diabetes mellitus.
Heidelberglaan 100
3584 CX Utrecht
NL
Heidelberglaan 100
3584 CX Utrecht
NL
Listed location countries
Age
Inclusion criteria
1. healthy controls (matched by age and gender)
2. type II DM patients, treated with oral bloodglucose lowering agents (biguanides or sulfonylurea derivates)
Exclusion criteria
pregnancy; use of anti-epileptic drugs; use of acetylsalicylacid, NSAID, GPIIb-IIa antagonists, heparin or thrombolytica; known diabetic retinopathy; smoking; hypersensitivity to the drug substance or any component of the product; severe liverfunctiondisorder; active pathological bleeding such as peptic ulcer or intracranial hemorrhage; breastfeeding; surgery or dental operation 7 days prior or 7 days after the start of clopidogrel intake; galactose intolerance, lapp lactase deficiency or glucose galactose malabsorbtion
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 | EUCTR2008-004147-11-NL |
| CCMO | NL23416.041.08 |