Objective of the study is to investigate the effects of aspirin on the platelet function of healthy volunteers and of patients with ischemic stroke. In another part of the study, we will investigate whether or not the effects of aspirin on theā¦
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
thromboxane B2
optical aggregometry
PFA closure time
trombinegeneration measurement in Platelet Rich Plasma
impedance aggregometry in whole blood
Secondary outcome
not applicable
Background summary
Aspirin inhibits platelet aggregation through an irreversible and competitive
binding with the enzyme cyclo-oxygenase (COX). Cyclooxygenase is required for
thromboxane synthesis, which is a strong vasoconstrictor and platelet
triggerer. Through these mechanisms the use aspirin in patients with
cardiovascular disease leads to a significant risk reduction. However, not all
patients seem to benefit from the use of aspirin. An important part of the
patients seem to have high platelet activity despite the use of aspirin. This
is also called laboratory aspirin resistance, which can be identified by the
use of several platelet function tests. Previous studies have shown that in
cardiology patients with laboratory aspirin resistance, there is an increased
cardiovascular risk. In case of ischemic stroke, this correlation isn't proven
yet.
Study objective
Objective of the study is to investigate the effects of aspirin on the platelet
function of healthy volunteers and of patients with ischemic stroke. In another
part of the study, we will investigate whether or not the effects of aspirin on
the platelets of patients without recurrent disease differs from the effects of
patients with recurrent disease despite the use of aspirin. Next to standard
platelet function tests we will also include the thrombinegeneration
measurement.
Study design
It is an intervention study with 12 healty volunteers. They have to take
carbasalate calcium 100mg daily during 7 days. On day 0 and dag 6 of the study,
subjects have to come to the hospital, where bloods will be drawn before and
after the ingestion of carbasalate calcium in order to study the effects of
carbasatale calcium of the platelet function.
Another part of the study will be a pilot study with 24 patients with an
ischemic stroke based on large vessel disease in the medical history. The event
must have taken place between 01-07-01 and 01-07-06. All patients are treated
with carbasalate calcium 100mg daily. 12 of the 24 patients have recurrent
disease despite carbasalate calcium and 12 of the 24 patients don't have
recurrent disease. Patients have to come to the hospital once: bloods will be
drawn before and after the ingestion of carbasalate calcium in order to
investigate the effects of carbasalate calcium on the platelet function.
Intervention
population A
100 mg of carbasalate calcium daily, during a period of 7 days
2x2 venapuntions
Population B
2 venapunctions
no additional medical treatment
Study burden and risks
Population A
The subjects will be treated with carbasalate calium 100mg daily during a
period fof 7 days. The risk is minimal and equal to the risks of the use of
carbasalate calcium. In order to minimalise the risks we will exclude
volunteers with any knows (relative) contra-indication for aspirin.
The subjects will have to come to the hospital on day 0. In addition, blood
will be obtained by 2 times a venapuntion (once before and once 2.5 hours after
the intake of carbasalate calcium 100mg). The same procedure will be repeated
on day 6.
Population B
Patients from population B are already treated with carbasalate calcium 100mg
daily. The medical treatment will remain the same during and after the study.
These subjects will have to come to the hospital once. In addition blood will
be obtained by 2 times a venapunction (once before and once after the intake of
carbasalate calcium).
postbus 5800
6202AZ Maastricht
Nederland
postbus 5800
6202AZ Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
population A: healthy, BMI <27.5, non smoker.
Population B1: stroke in medical history (large vessel disease) between 01-07-01 and 01-07-06. No- recurrent stroke. Therapie with carbasalate calcium 100mg daily.
Population B2: recurrent stroke in medical history despite therapy with carbasalate calcium 100mg daily. First stroke between 01-07-01 and 01-07-06. last stoke > 3 months ago.
Exclusion criteria
Population A: any contra-indication for carbasalate calcium. The use of NSAIDs. Cardiovascular disease, Diabetes Mellitus. recent operation (3 months)
Population B: therapy with clopidogrel, NSAIDs, oral anticoagulation therapy. Known malignancy, operation < 3 months ago. Cardiovascular event < 3 months ago. Known hematologic disease. Thrombocytopenia(< 100000/mm3), thrombocytosis (> 400 000/mm3), anemia, polycytemia (Ht>50%)
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 | EUCTR2007-004354-90-NL |
CCMO | NL19043.068.07 |