NCT02026713

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: University of Roma La Sapienza · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
OTHER	quit smoking for a 2 weeks period	evaluate the platelet reactivity after 15 days by quit smoking

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-06-01
• Completion: 2015-07-01
• First posted: 2014-01-03
• Last updated: 2015-06-09

Locations

1 site across 1 country: Italy