Patients who developed an acute coronary syndrome despite dual antiplatelet therapy with aspirin and clopidogrel may benefit from a further dose of clopidogrel before a percutaneous coronary intervention. The aim of this study is to evaluate safety and effectiveness of clopidogrel reloading in patients on chronic clopidogrel therapy with acute coronary syndrome undergoing percutaneous coronary intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
240
600 mg clopidogrel loading dose 6-8 h before diagnostic coronary angiogram
Placebo in addition to the chronic daily dose of 75 mg
Vito Fazzi Hospital
Lecce, Lecce, Italy
RECRUITINGCampus Bio-Medico University
Rome, Rome, Italy
RECRUITINGMajor Adverse Cardiovascular Events
Death Myocardial Infarction Target Vessel Revascularization
Time frame: 30 days
Bleeding Events
Occurrence of vascular/bleeding complications, defined as: (a) major bleeding (intracranial bleeding or clinically overt bleeding associated with a decrease in haemoglobin \>5 g/dL, according to the TIMI criteria); (b) minor bleeding (clinically overt haemorrhage associated with a fall in haemoglobin ≤5 g/dL); (c) entry-site complications (haematoma \>5 cm, pseudoaneurysm or arteriovenous fistula)
Time frame: 30 days
Grade of platelet residual reactivity
Patient's response to clopidogrel at 3 different timing, assessed with VerifyNow P2Y12 Assays. The first timing is immediately before PCI (4-6h after randomization), once accomplished the diagnostic angiogram. The second and third timings are, respectively, 8h and 24h after PCI.
Time frame: Immediately before PCI (4-6h after randomization), 8h and 24h after PCI
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