Coronary Artery Disease Clinical Trial
Official title:
Impact of the Degree of Peri-Interventional Platelet Inhibition After Loading With Clopidogrel on Early Clinical Outcome of Elective Coronary Stent Placement
This study is a prospective, single-center evaluation of the impact of the variability in platelet response after loading with clopidogrel on the peri-interventional risk of patients undergoing PCI.
Background: Platelet responses after loading with clopidogrel are highly variable. The
impact of this variability on the peri-interventional risk of patients undergoing PCI has
not been investigated prospectively.
Objectives: Our prospective study test the hypothesis that the 30-day clinical outcome of
elective percutaneous catheter intervention (PCI) differs between strata defined by
quartiles of platelet aggregation after loading with 600mg of clopidogrel. Further on we
will investigate impact of the variability in platelet response on long-term outcome after
PCI.
Methods: Our study will include consecutive patients undergoing elective coronary stent
placement. Before PCI, patients receive a loading dose of 600mg of clopidogrel followed by
75mg daily. Primary end point is the 30-day composite of death, myocardial infarction and
target lesion revascularization (MACE). Platelet aggregation was assessed immediately before
PCI by optical aggregometry (5µmol/L ADP).
Sample size calculation was based on ISAR-REACT which comprised a cohort with similar
selection criteria and treatment strategy. Thus, we assume an incidence of the primary end
point of 4.2%. We design our study to test the hypothesis that the incidence of the primary
end point differed by quartiles of ADP-induced platelet aggregation. We intend to have a
power of 0.80 to detect an effect size of 0.015 (for example 3-fold risk in 4th quartile)
with a 2-sided P-value less than 0.05. With these assumptions we obtain a sample size of at
least 748 and aime for a cohort of 800.
;
Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal
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