Evaluation of Efficacy/Safety in Cangrelor use in patients with SCAD undergoing complex PCI. Prospective, observational, multicenter registry.
SCAD patients routinely in the Italian centers undergo complex PCIs with pre-treatment with P2Y12 inhibitors or with P2Y12 inhibitors administration after procedure. This implies that participants receive interventions as part of routine medical care, and that researchers actually observe the effect of the intervention.
Study Type
OBSERVATIONAL
Enrollment
550
Ospedale Santa Maria
Bari, Apulia, Italy
Safety endpoint: Major bleedings according with Thrombolysis in Myocardial Infarction (TIMI) classification.
Number of patients with intracranial hemorrhage or a ≥5 g/dl decrease in hemoglobin concentration or a ≥15 % absolute decrease in hematocrit.
Time frame: hour 48
Efficacy endpoint: Long-term major adverse cardiac and cerebrovascular events MACCE (eg Death from any cause, Any Myocardial infarction, Revascularization, Stroke)
Number of patients with Long-term major adverse cardiac and cerebrovascular events (MACCE) (e.g. Death from any cause, Any Myocardial infarction, Revascularization, Stroke)
Time frame: hour 48 and day 30
Assessment of platelet reactivity
Assessment of platelet reactivity measured by the VerifyNow® P2Y12 assay. Pharmacodynamic measurements will occur according to manufacturer instructions before, during, and after study drug infusion.
Time frame: Day 0
Number of Participants with stent thrombosis
Number of Participants with stent thrombosis demonstrated by coronary angiography
Time frame: hour 48
Rehospitalisation due to unstable or progressive angina according to the Braunwald Unstable Angina Classification and the Canadian Cardiovascular Society Angina Classification.
Rehospitalisation due to unstable or progressive angina according to the Braunwald Unstable Angina Classification and the Canadian Cardiovascular Society Angina Classification.
Time frame: Day 30
Time to Coronary Artery Bypass Graft (CABG)
Time between the intervention and the Coronary Artery Bypass Graft (CABG)
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Time frame: Day 30