The purpose of this study is to measure platelet reactivity at different time points in patients with platelet inhibitors. The primary research question in the intra-individual variety of platelet reactivity.
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Platelet reactivity (measured by VerifyNow, VASP and PACT) at four different
time points in patients undergoing carotid endarterectomy (CEA) and are treated
with aspirin + P2Y12 inhibitor
Secondary outcome
Early thrombotic cardiovascular events (<2.5 months after surgery):
cardiovascular death, transient ischemic attack, stroke, myocardial infarction,
stent thrombosis, acute limb ischemia and the need for peripheral
revascularization
Early bleeding complications (<2.5 months after surgery): secondary bleeding
after surgery, gastrointestinal bleeding and brain hemorrhage.
Presence of a known CYP2C19 mutation
Quantification of platelet markers as (beta-thromboglobulin, platelet derived
growth factor, RANTES and platelet- factor 4).
Background summary
After a first manifestation of vascular diseases, there is an increased risk of
recurrence at the same site or at a different location of the vascular bed.
Platelet inhibitors are prescribed in order to prevent these secondary
cardiovascular events such as myocardial infarction, stroke or TIA. Although
platelet inhibitors reduce the risk of a thrombotic event, the risk of bleeding
increases. This indicates a narrow therapeutic range of platelet inhibitors.
Monitoring of the effectiveness of the platelet inhibitors may prevent under-
and over-treatment, and thereby reduce the incidence of thrombotic or bleeding
complications. Monitoring is done by different platelet reactivity test with
varying sensitivity and specificity. At this time, there is no proven
superiority of one of these tests.
The decision to proceed with a certain platelet inhibitor or to switch to a
different medicament, is taken on the basis of a single platelet reactivity
measurement. However, it is known that in healthy volunteers, without platelet
inhibitors, there is a variability of platelet reactivy between different time
intervals. A study which will studied platelet reactivity in patients on
clopidogrel, observed a variation in platelet reactivity between the two time
points. However, this study is of moderate quality, so there are no direct
conclusions that can be drawn from this study.
Study objective
The purpose of this study is to measure platelet reactivity at different time
points in patients with platelet inhibitors. The primary research question in
the intra-individual variety of platelet reactivity.
Study design
Observational cohort study.
Study burden and risks
The burden for participant is low for the study. The subjects have to visit the
hospital one time extra and undergo two extra venepunctures.
The burdens and risks of the venepunctures are low enough to justify
participation of participants. Thereby, the treatment of a very large group of
patients can be improved through this study.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
-Taking antiplatelet therapy
- Undergoing elective carotid endarterectomy
- Admitted to the hospital at least 1 day postoperative
- older than 18 years
Exclusion criteria
- indication for postoperative Intensive Care opname
- are treated with vitamine K antagonists
- Need of per- or postoperative blood transfusion
Design
Recruitment
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 |
|---|---|
| CCMO | NL54610.041.15 |