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LAPCOR: The Laboratory AntiPlatelet Efficacy and Clinical Outcome Registry

Sponsor
Faculty Hospital Kralovske Vinohrady (Other)
Overall Status
Completed
CT.gov ID
NCT02264912
Collaborator
(none)
2,016
Enrollment
1
Location
120
Duration (Months)
16.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The ongoing LAPCOR (Laboratory AntiPlatelet efficacy and Clinical Outcome Registry) registry was initiated in 2008 at a tertiary care cardiac center, and consecutive patients, who underwent intracoronary stent implantation, have been included regardless of whether percutaneous coronary intervention (PCI) was performed on urgent or elective basis.Patients were included in the registry after having signed an informed consent for participation. No exclusion criterion has been applied for the registry participation. Efficacy of P2Y12 receptor antagonists has been measured by quantitative flow cytometric analysis of vasodilator-stimulated phosphoprotein (VASP) phosphorylation according to the manufacturer protocol (Platelet VASP; Diagnostica Stago, Biocytex, Asnières, France) on a FACScan flow cytometer (Becton Dickinson). Occurrence of major adverse cardiac events at 30 days, 6-months and one year follow up has been investigated.

Condition or Disease Intervention/Treatment Phase
  • Drug: antiplatelet drugs - P2Y12 antagonists

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
2016 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Laboratory AntiPlatelet Efficacy and Clinical Outcome Registry
Study Start Date :
Jul 1, 2008
Actual Primary Completion Date :
Aug 1, 2017
Actual Study Completion Date :
Jul 1, 2018

Arms and Interventions

Arm Intervention/Treatment
stent-PCI patients

Consecutive patients, who underwent intracoronary stent implantation, have been included regardless of whether percutaneous coronary intervention (PCI) was performed on urgent or elective basis.

Drug: antiplatelet drugs - P2Y12 antagonists
Other Names:
  • clopidogrel, prasugrel, ticagrelor

    		•

    Outcome Measures

    Primary Outcome Measures

    1. laboratory efficacy of antiplatelet drugs measured as residual platelet reactivity, incidence of major adverse cardiovascular events and bleeding complications [During the 12 months after implantation of an intracoronary stent]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients after stent PCI treated with P2Y12 antagonist

    • Written informed consent

    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty Hospital Kralovske Vinohrady Prague Czechia 10034

    Sponsors and Collaborators

    • Faculty Hospital Kralovske Vinohrady

    Investigators

    • Principal Investigator: Zuzana Motovska, MD.PhD., Faculty Hospital Kralovske Vinohrady

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zuzana Motovska, Associate Professor, MD. PhD. FESC., Faculty Hospital Kralovske Vinohrady
    ClinicalTrials.gov Identifier:
    NCT02264912
    Other Study ID Numbers:
    • 05-2008
    First Posted:
    Oct 15, 2014
    Last Update Posted:
    Jul 22, 2020
    Last Verified:
    Jul 1, 2020
    Keywords provided by Zuzana Motovska, Associate Professor, MD. PhD. FESC., Faculty Hospital Kralovske Vinohrady
    antiplatelets, percutanous coronary intervention, acute coronary syndromes, laboratory efficacy
    Additional relevant MeSH terms:
    Clopidogrel
    Ticagrelor
    Prasugrel Hydrochloride
    Platelet Aggregation Inhibitors

    Study Results

    No Results Posted as of Jul 22, 2020