Potential Impact of Cigarette Smoking on Platelet Reactivity in Patients on Dual Antiplatelet Therapy With P2Y12 Inhibitors
NCT ID: NCT02026713
Last Updated: 2015-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
150 participants
INTERVENTIONAL
2014-07-31
2015-07-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
NONE
Study Groups
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smokers on dual antiplatelet therapy with ASA and Prasugrel or
All patients quit smoking for a 2 weeks period
quit smoking for a 2 weeks period
evaluate the platelet reactivity after 15 days by quit smoking
smokers on dual antiplatelet therapy with ASA and ticagrelor
All patients on chronic dual antiplatelet therapy (\>1 month) quit smoking for a 2 weeks period
quit smoking for a 2 weeks period
evaluate the platelet reactivity after 15 days by quit smoking
smokers on dual antiplatelet therapy with ASA and Clopidogrel
All patients on chronic dual antiplatelet therapy (\>1 month) quit smoking for a 2 weeks period
quit smoking for a 2 weeks period
evaluate the platelet reactivity after 15 days by quit smoking
Interventions
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quit smoking for a 2 weeks period
evaluate the platelet reactivity after 15 days by quit smoking
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
90 Years
ALL
No
Sponsors
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University of Roma La Sapienza
OTHER
Responsible Party
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Polacco Marina
MD
Principal Investigators
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marina MD polacco, medicine
Role: PRINCIPAL_INVESTIGATOR
University of Roma La Sapienza
Locations
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Sapienza University of Rome
Rome, Roma, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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WD-131213
Identifier Type: -
Identifier Source: org_study_id
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