Ignite Creation Date:
2024-05-06 @ 8:13 AM
Last Modification Date:
2024-10-26 @ 11:57 AM
Study NCT ID:
NCT02690454
Status:
COMPLETED
Last Update Posted:
2016-08-17
First Post:
2015-11-26
Brief Title:
Which Platelet Function Test Best Reflects the In Vivo Plasma Concentrations of Ticagrelor and Its Active Metabolite
Sponsor:
Collegium Medicum w Bydgoszczy
Organization:
Collegium Medicum w Bydgoszczy
Study Overview
Official Title:
Which Platelet Function Test Provides the Best Reflection of the in Vivo Plasma Concentrations of Ticagrelor and Its Active Metabolite A Pharmacokinetic and Pharmacodynamic Study Including Patients With Myocardial Infarction
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HARMONIC
Brief Summary:
Ticagrelor is a direct-acting reversible platelet P2Y12 receptor inhibitor recommended by the recent European Society of Cardiology guidelines in patients with acute coronary syndromes ACS class of recommendation I level of evidence B Ticagrelor inhibits platelet function stronger faster and more consistently than clopidogrel the former standard of antiplatelet therapy In the landmark PLATO trial Study of PLATelet inhibition and patient Outcomes ticagrelor therapy as compared with clopidogrel treatment was associated with the reduced occurrence of major adverse cardiovascular events and all-cause mortality but also resulted in a small but statistically significant increase in the rate of major bleeding The optimum choice of antiplatelet treatment aimed to provide each patient with maximum protection against ischemic events while minimizing the risk of bleeding complications is the challenge of contemporary ACS therapy The tool which may help physicians and facilitate clinical decision making is platelet function testing According to the guidance of both European and American groups of experts there are three currently recommended platelet function tests namely the VerifyNow device the Multiplate analyzer and the Vasodilator Stimulated Phosphoprotein Phosphorylation VASP assay It needs to be emphasized that none of these three methods is preferred over others So far there are no studies linking pharmacokinetic analysis of ticagrelor and its active metabolite with comparative evaluation of platelet reactivity The aim of this trial is to assess the relationship between concentrations of ticagrelor and its active metabolite AR-C124910XX and results of all three recommended platelet function tests in patients with myocardial infarction Patients who receive GP IIbIIIa receptor inhibitor will be excluded from the primary analysis
Statistical analysis The correlation will be assessed using correlation coefficients and intraclass correlation coefficients while the agreement between the results of the compared platelet function tests will be measured using the Kappa statistic and Bland-Altman analysis
Statistical analysis The correlation will be assessed using correlation coefficients and intraclass correlation coefficients while the agreement between the results of the compared platelet function tests will be measured using the Kappa statistic and Bland-Altman analysis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None