Coronary Artery Disease Clinical Trial
Official title:
"Impact of Cigarette Smoking on Platelet Reactivity in Patients With Acute Coronary Syndromes on Dual Antiplatelet Therapy With P2Y12 Inhibitors" - Trial COPTER -
All consecutive patients undergone PTCA in the period between July 2013 and December 2013
are eligible to be enrolled. Study population are divided in :
Group 1: smokers on dual antiplatelet therapy with ASA (100 mg once a day) and Prasugrel (10
mg die); Group 2: smokers on dual antiplatelet therapy with ASA(100 mg once a day) and
Ticagrelor (90 mg twice a day); Control group: smokers on dual antiplatelet therapy with
ASA(100 mg once a day) and Clopidogrel (75 mg once a day).
Platelet function is evaluated using a validated method: the VerifyNow System (Accumetrics
Inc., San Diego, CA), which is a point-of-care turbidimetry-based optical detection system
that measures platelet-induced aggregation. These value are measured Platelet function,
measured with the VerifyNow P2Y12. All patients on chronic dual antiplatelet therapy (>1
month) quit smoking for a 2 weeks period. Therefore PRU values are obtained at baseline (at
the enrollment time) and after 2 weeks after smoking cessation. Platelet reactivity are
expressed in P2Y12 reaction units (PRU). PRU values >240 are suggestive of high platelet
reactivity.
Primary outcomes: P2Y12 reaction units (PRU) at baseline and two weeks after quitting
smoking.
All consecutive patients undergone PTCA in the period between July 2013 and December 2013
are eligible to be enrolled. Study population are divided in :
Group 1: smokers on dual antiplatelet therapy with ASA (100 mg once a day) and Prasugrel (10
mg die); Group 2: smokers on dual antiplatelet therapy with ASA(100 mg once a day) and
Ticagrelor (90 mg twice a day); Control group: smokers on dual antiplatelet therapy with
ASA(100 mg once a day) and Clopidogrel (75 mg once a day).
Platelet function is evaluated using a validated method: the VerifyNow System (Accumetrics
Inc., San Diego, CA), which is a point-of-care turbidimetry-based optical detection system
that measures platelet-induced aggregation. These value are measured Platelet function,
measured with the VerifyNow P2Y12. All patients on chronic dual antiplatelet therapy (>1
month) quit smoking for a 2 weeks period. Therefore PRU values are obtained at baseline (at
the enrollment time) and after 2 weeks after smoking cessation. Platelet reactivity are
expressed in P2Y12 reaction units (PRU). PRU values >240 are suggestive of high platelet
reactivity.
Primary outcomes: P2Y12 reaction units (PRU) at baseline and two weeks after quitting
smoking.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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