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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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02026713
Acronym
COPTER
Enrollment
150
Registered
2014-01-03
Start date
2014-07-31
Completion date
2015-07-31
Last updated
2015-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

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.

Interventions

OTHERquit smoking for a 2 weeks period

evaluate the platelet reactivity after 15 days by quit smoking

Sponsors

University of Roma La Sapienza
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Assessment of platelet reaction units (PRU)after 2 weeks of quitting smokingAbsolute changes in platelet reactivity (expressed as P2Y(12) reaction units by the point-of-care VerifyNow assay \[Accumetrics, San Diego, California\])

Countries

Italy

Contacts

Primary ContactMarina Polacco
dott.mpolacco@gmail.com3333347960

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026