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

NCT02026713 | Unknown Phase 4

• 1 other identifier: WD-131213
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Assessment of platelet reaction units (PRU)

  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

Study Arms (3)

smokers on dual antiplatelet therapy with ASA and Prasugrel or

EXPERIMENTAL

All patients quit smoking for a 2 weeks period

Other: quit smoking for a 2 weeks period

smokers on dual antiplatelet therapy with ASA and ticagrelor

EXPERIMENTAL

All patients on chronic dual antiplatelet therapy (\>1 month) quit smoking for a 2 weeks period

Other: quit smoking for a 2 weeks period

smokers on dual antiplatelet therapy with ASA and Clopidogrel

ACTIVE COMPARATOR

All patients on chronic dual antiplatelet therapy (\>1 month) quit smoking for a 2 weeks period

Other: quit smoking for a 2 weeks period

Interventions

quit smoking for a 2 weeks period OTHER

evaluate the platelet reactivity after 15 days by quit smoking

smokers on dual antiplatelet therapy with ASA and Clopidogrel; smokers on dual antiplatelet therapy with ASA and Prasugrel or; smokers on dual antiplatelet therapy with ASA and ticagrelor

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- people unable to understand and willing to sign the informed consent form

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Sapienza University of Rome

Rome, Roma, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 26849144 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• marina MD polacco, medicine

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marina Polacco

CONTACT

3333347960; dott.mpolacco@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 18, 2013
• First Posted: January 3, 2014
• Study Start: July 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2015
• Last Updated: June 9, 2015

Record last verified: 2015-06

Locations

IT (1)