Clinical trial NCT02026713: Potential Impact of Cigarette Smoking on Platelet Reactivity in Patients on Dual Antiplatelet Therapy With P2Y12 Inhibitors
Official title: "Impact of Cigarette Smoking on Platelet Reactivity in Patients With Acute Coronary Syndromes on Dual Antiplatelet Therapy With P2Y12 Inhibitors" - Trial COPTER -
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2014-01-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of platelet reaction units (PRU)
timeFrame: after 2 weeks of quitting smoking
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Sapienza University of Rome
state: Roma
Study officials:
affiliation: University of Roma La Sapienza
name: marina MD polacco, medicine
role: PRINCIPAL_INVESTIGATOR
References:
citation: Patti G, Polacco M, Taurino E, Gaudio C, Greco C. Effects of cigarette smoking on platelet reactivity during P2Y12 inhibition in patients with myocardial infarction undergoing drug-eluting stent implantation: results from the prospective cigarette smoking on platelet reactivity (COPTER) study. J Thromb Thrombolysis. 2016 May;41(4):648-53. doi: 10.1007/s11239-016-1341-8.