- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02026713
Potential Impact of Cigarette Smoking on Platelet Reactivity in Patients on Dual Antiplatelet Therapy With P2Y12 Inhibitors (COPTER)
"Impact of Cigarette Smoking on Platelet Reactivity in Patients With Acute Coronary Syndromes on Dual Antiplatelet Therapy With P2Y12 Inhibitors" - Trial COPTER -
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Marina Polacco
- Phone Number: 3333347960
- Email: dott.mpolacco@gmail.com
Study Locations
-
-
Roma
-
Rome, Roma, Italy
- Recruiting
- Sapienza University of Rome
-
Contact:
- Marina Polacco
- Phone Number: 3333347960
- Email: dott.mpolacco@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: smokers on dual antiplatelet therapy with ASA and Prasugrel or
All patients quit smoking for a 2 weeks period
|
evaluate the platelet reactivity after 15 days by quit smoking
|
Experimental: 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
|
evaluate the platelet reactivity after 15 days by quit smoking
|
Active Comparator: 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
|
evaluate the platelet reactivity after 15 days by quit smoking
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of platelet reaction units (PRU)
Time Frame: 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])
|
after 2 weeks of quitting smoking
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: marina MD polacco, medicine, University of Roma La Sapienza
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WD-131213
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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