Stent Thrombosis Clinical Trial
Official title:
REsponsiveness to CLOpidogrel and Stent-related Events in Acute Coronary. Reclose 2-ACS Registry
The main objective of the project is to assess the long-term prognostic impact of residual
platelet reactivity after optimal antiplatelet therapy in a large cohort of patients with
acute coronary syndrome undergoing invasive strategy.
Follow-up length will be at least 24 months. The primary end-point of the study will be a
composite of death, myocardial infarction, urgent target vessel revascularization, stent
thrombosis or stroke.
This study is mainly based on a registry of 2000 consecutive patients with acute coronary
syndrome who received invasive treatment and for whom platelet reactivity after clopidogrel
treatment will be prospectively assessed.
In the acute phase, blood samples for platelet reactivity assessment will be obtained 12 to
18 hours from 600 mg clopidogrel loading. Platelet-rich plasma, obtained by centrifuging
whole blood for 10 min at 200 g, was stimulated with 10 M adenosine 5'-diphosphate (ADP) and
residual aggregation will be assessed using a APACT 4 light transmittance aggregometer.
Platelet aggregation (according to the Born's method) will be evaluated considering the
maximal percentage of platelet aggregation in response to stimulus. Patients with platelet
aggregation by 10 µmol ADP ≥ 90th percentile of controls (70%) will be defined as
non-responders. The assessment of platelet reactivity will be repeated at 6 months. The
importance of concomitant aspirin resistance will be also evaluated in such of patients.
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Observational Model: Cohort, Time Perspective: Prospective
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