Potential Impact of Cigarette Smoking on Platelet Reactivity in Patients on Dual Antiplatelet Therapy With P2Y12 Inhibitors
- Conditions
- Coronary Artery Disease
- Interventions
- Other: quit smoking for a 2 weeks period
- Registration Number
- NCT02026713
- Lead Sponsor
- University of Roma La Sapienza
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
- 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
- people unable to understand and willing to sign the informed consent form
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description smokers on dual antiplatelet therapy with ASA and Prasugrel or quit smoking for a 2 weeks period All patients quit smoking for a 2 weeks period smokers on dual antiplatelet therapy with ASA and ticagrelor quit smoking for a 2 weeks period All patients on chronic dual antiplatelet therapy (\>1 month) quit smoking for a 2 weeks period smokers on dual antiplatelet therapy with ASA and Clopidogrel quit smoking for a 2 weeks period All patients on chronic dual antiplatelet therapy (\>1 month) quit smoking for a 2 weeks period
- Primary Outcome Measures
Name Time Method Assessment of platelet reaction units (PRU) after 2 weeks of quitting smoking Absolute changes in platelet reactivity (expressed as P2Y(12) reaction units by the point-of-care VerifyNow assay \[Accumetrics, San Diego, California\])
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sapienza University of Rome
🇮🇹Rome, Roma, Italy