Clinical trial NCT02264912: The Laboratory AntiPlatelet Efficacy and Clinical Outcome Registry
Official title: The Laboratory AntiPlatelet Efficacy and Clinical Outcome Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Platelet Aggregation Onhibitors
Keywords: antiplatelets, percutanous coronary intervention, acute coronary syndromes, laboratory efficacy
Lead sponsor: Faculty Hospital Kralovske Vinohrady
Sponsor class: OTHER_GOV
First posted: 2014-10-15
Enrollment: 2016
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients were included in the registry after having signed an informed consent for participation. No exclusion criterion has been applied for the registry participation.

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.


Eligibility criteria: Inclusion Criteria:

* Patients after stent PCI treated with P2Y12 antagonist
* Written informed consent

Exclusion Criteria:

- None

Primary outcomes:
measure: laboratory efficacy of antiplatelet drugs measured as residual platelet reactivity, incidence of major adverse cardiovascular events and bleeding complications
timeFrame: During the 12 months after implantation of an intracoronary stent
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Faculty Hospital Kralovske Vinohrady
Study officials:
affiliation: Faculty Hospital Kralovske Vinohrady
name: Zuzana Motovska, MD.PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Motovska Z, Odvodyova D, Fischerova M, Stepankova S, Maly M, Morawska P, Widimsky P. Renal function assessed using cystatin C and antiplatelet efficacy of clopidogrel assessed using the vasodilator-stimulated phosphoprotein index in patients having percutaneous coronary intervention. Am J Cardiol. 2012 Mar 1;109(5):620-3. doi: 10.1016/j.amjcard.2011.10.019. Epub 2011 Dec 10.
citation: Motovska Z, Ondrakova M, Doktorova M, Widimsky P. Severe left ventricular systolic dysfunction is independently associated with high on-clopidogrel platelet reactivity. Am J Cardiovasc Drugs. 2014 Aug;14(4):313-8. doi: 10.1007/s40256-014-0074-3.
citation: Ondrakova M, Knot J, Ulman J, Maly M, Motovska Z. Efficacy of P2Y12 receptor antagonists in patients with atrial fibrillation according to the CHA2DS2VASc score. Int J Cardiol. 2016 Mar 15;207:84-6. doi: 10.1016/j.ijcard.2016.01.039. Epub 2016 Jan 6. No abstract available.
citation: Motovska Z, Ondrakova M, Bednar F, Knot J, Ulman J, Maly M. Selection of P2Y12 antagonist, treatment initiation, and predictors of high on-treatment platelet reactivity in a "Real World" registry. Thromb Res. 2015 Jun;135(6):1093-9. doi: 10.1016/j.thromres.2015.04.014. Epub 2015 Apr 16.