To determine whether platelet reactivity unit (PRU) values as assessed with the VerifyNow P2Y12 assay are influenced by the performance of a PCI procedure
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the difference in mean PRU value before and after the
procedure in the arterial blood samples in patients treated with clopidogrel.
Secondary outcome
Secondary endpoint is the difference in mean PRU value before and after the
procedure in the venous blood samples.
Secondary endpoint is the difference in mean PRU value between arterial and
venous blood samples before and after the procedure.
Secondary endpoint is the difference in the rate of HPR before and after the
procedure in arterial blood samples and in venous blood samples.
Secondary endpoint is the correlation between hematocrit and PRU values
Background summary
Dual antiplatelet therapy (DAPT) is essential in the treatment of patients
undergoing a percutaneous coronary intervention (PCI) to prevent
atherothrombotic events such as stent thrombosis. However, in a substantial
amount of patients receiving aspirin and clopidogrel the anticipated
antiplatelet effect, as assessed with platelet function assays, is not
optimally achieved. This state of so-called high platelet reactivity (HPR)
observed in patients treated with these antiplatelet drugs is associated with a
worse clinical outcome in patients who underwent PCI.
The occurrence of HPR is associated with many factors. The efficacy of the
antiplatelet drug is influenced by clinical, pharmacologic and genetic factors,
and some of those factors also have direct influence on platelet reactivity.
The performance of the PCI procedure itself might also influence platelet
reactivity. In fact, a study using the Multiplate platelet function test showed
that platelet reactivity was elevated in patients after PCI. We want to
investigate if platelet reactivity as assessed with the most frequently used
platelet function test, the VerifyNow P2Y12 assay, is also influenced by
performance of a PCI procedure.
Study objective
To determine whether platelet reactivity unit (PRU) values as assessed with the
VerifyNow P2Y12 assay are influenced by the performance of a PCI procedure
Study design
Non-randomized, open label, single center study.
Study burden and risks
The patient will be informed about the study and written informed consent will
be obtained before the patient enters the study. Blood samples will
predominantly be obtained from vessels that are already punctured as part of
routine care. As blood sampling though venipuncture is the only additional
procedure, the study is not associated with any significant risks.
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Listed location countries
Age
Inclusion criteria
1. Scheduled for PCI
2. Adequately treated with clopidogrel (for the definition of adequate treatment see protocol page 9)
Exclusion criteria
1. Unable or unwilling to give informed consent
2. Presentation with ST-segment elevated myocardial infarction (STEMI)
3. Thrombolytic therapy within 24 hours before PCI or GPIIb/IIIa-inhibitors within the last 14 days
4. Laboratory results or diseases leading to unreliable VerifyNow results such as a known platelet count <100*10^9/L or coagulopathy or platelet disorder or a Haemoglobin < 6.5 or Hematocrit < 33%.
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 | NL47163.100.13 |