Potential Impact of Cigarette Smoking on Platelet Reactivity in Patients on Dual Antiplatelet Therapy With P2Y12 Inhibitors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Impact of Cigarette Smoking on Platelet Reactivity in Patients With Acute Coronary Syndromes on Dual Antiplatelet Therapy With P2Y12 Inhibitors - Trial COPTER -

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Other: quit smoking for a 2 weeks period


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All consecutive patients undergone PTCA in our institution in the period between July 2013 and December 2013 will be eligible to be enrolled. smokers will be all patients smoking 15±10 cigarettes daily. patients on dual antiplatelet therapy with ASA and P2Y12 inhibitors. recent (<12 months) percutaneous coronary interventions angiographically-proven coronary artery disease Exclusion Criteria: - people unable to understand and willing to sign the informed consent form

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: smokers on dual antiplatelet therapy with ASA and Prasugrel or<br>All patients quit smoking for a 2 weeks period | Other: quit smoking for a 2 weeks period<br>* evaluate the platelet reactivity after 15 days by quit smoking<br>|
| Experimental: smokers on dual antiplatelet therapy with ASA and ticagrelor<br>All patients on chronic dual antiplatelet therapy (>1 month) quit smoking for a 2 weeks period | Other: quit smoking for a 2 weeks period<br>* evaluate the platelet reactivity after 15 days by quit smoking<br>|
| Active Comparator: smokers on dual antiplatelet therapy with ASA and Clopidogrel<br>All patients on chronic dual antiplatelet therapy (>1 month) quit smoking for a 2 weeks period | Other: quit smoking for a 2 weeks period<br>* evaluate the platelet reactivity after 15 days by quit smoking<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of platelet reaction units (PRU) | Absolute changes in platelet reactivity (expressed as P2Y(12) reaction units by the point-of-care VerifyNow assay [Accumetrics, San Diego, California]) | after 2 weeks of quitting smoking |