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

June 7, 2015 updated by: Polacco Marina, University of Roma La Sapienza

"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

Unknown

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

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Roma
      • Rome, Roma, Italy
        • Recruiting
        • Sapienza University of Rome
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Other: 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
Other: 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
Other: 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

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Investigators

  • Principal Investigator: marina MD polacco, medicine, University of Roma La Sapienza

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Anticipated)

July 1, 2015

Study Registration Dates

First Submitted

December 18, 2013

First Submitted That Met QC Criteria

January 1, 2014

First Posted (Estimate)

January 3, 2014

Study Record Updates

Last Update Posted (Estimate)

June 9, 2015

Last Update Submitted That Met QC Criteria

June 7, 2015

Last Verified

June 1, 2015

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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