Ignite Creation Date:
2024-05-06 @ 2:35 AM
Last Modification Date:
2024-10-26 @ 11:20 AM
Study NCT ID:
NCT02071966
Status:
TERMINATED
Last Update Posted:
2016-07-26
First Post:
2014-02-21
Brief Title:
Study of Effects of Ticagrelor on Microparticles and Micro-RNA in NSTE-ACS
Sponsor:
Catholic University of the Sacred Heart
Organization:
Catholic University of the Sacred Heart
Study Overview
Official Title:
Effects of TIcaGREloR on Circulating Microparticles and Micro-RNAs in Patients With Non ST Elevation Acute Coronary Syndromes
Status:
TERMINATED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TIGER-M
Brief Summary:
The aim of the study is to learn more about the pathophysiology of acute coronary syndrome ACS and to evaluate the mechanisms responsible of the action and benefits of ticagrelor
Ticagrelor is an oral and reversible inhibitor of P2Y12 receptor Few information is available about the action of ticagrelor on the molecules involved in thrombogenesis and platelets activation in ACS
The aim of this study is to evaluate the mechanisms of ticagrelor action in vivo
It was observed that patients with myocardial infarction have higher blood levels of microparticles than patients with unstable angina or stable angina
The investigators assumed that ticagrelor benefits are represented by a reduction of microparticle levels a marker of endothelial dysfunction in patients with cardiovascular disease and by a modification in microRNAs pattern fragments of mRNA that have a regulatory action in various cellular processes such as proliferation differentiation growth and cellular death and represent new biomarkers in ACS
Ticagrelor is an oral and reversible inhibitor of P2Y12 receptor Few information is available about the action of ticagrelor on the molecules involved in thrombogenesis and platelets activation in ACS
The aim of this study is to evaluate the mechanisms of ticagrelor action in vivo
It was observed that patients with myocardial infarction have higher blood levels of microparticles than patients with unstable angina or stable angina
The investigators assumed that ticagrelor benefits are represented by a reduction of microparticle levels a marker of endothelial dysfunction in patients with cardiovascular disease and by a modification in microRNAs pattern fragments of mRNA that have a regulatory action in various cellular processes such as proliferation differentiation growth and cellular death and represent new biomarkers in ACS
Detailed Description:
Ticagrelor is an oral reversibly binding P2Y12 receptor inhibitor that yields in a dose-dependent fashion greater and more consistent inhibition of platelet aggregation than standard regimens of clopidogrel in patients with stable atherosclerotic disease and ACS However little information is available regarding its complex effect on thrombogenesis and platelet activation in acute coronary syndromes setting It has been widely demonstrated the potential role of MP in several biologic processes known to take part to pathophysiology of coronary syndromes such as inflammation coagulation and apoptosis Recent studies focused on miRNAs regulatory activity of several cellular processes such as proliferation differentiation development and cell death and on their role as biomarkers in ACS The investigators suppose that the observed major efficacy of ticagrelor is related to its actions on MP and microRNAs Considering the major clinical effectiveness shown by ticagrelor in comparison with clopidogrel the investigators hypothesize a more pronounced MP levels reduction as a possible mechanism for ticagrelor clinical benefits Moreover on the basis of the last evidences of microRNA involvement in the ACS pathophysiology the investigators aim to assess the effect of ticagrelor on microRNA expression in order to provide evidences for pleiotropic actions of this drug which could partially explain its major efficacy in reduction of cardiovascular events in ACS patients
In summary principal hypothesis of the study are
Considering that ticagrelor is a stronger P2Y12 receptor inhibitor than clopidogrel the investigators suppose that an increased inhibition of P2Y12 receptor by ticagrelor could reduce circulating levels of platelet and endothelial MP
In consideration of the observed role of microRNAs in expression of P2Y12 receptor the investigators speculate that patients susceptibility to P2Y12 receptor inhibitors could be influenced by microRNAs levels Moreover the investigators suppose that ticagrelor could influence microRNAs levels considered as marker of cardiovascular risk
Aims of the study are
to assess MP levels variation in Non ST-Elevation Acute Coronary Syndromes NSTE-ACS patients treated with ticagrelor in addition to low or high acetyl-salicylic acid ASA in comparison with clopidogrelASA treatment to demonstrate that major clinical efficacy of ticagrelor could be partially attributed to its influence on release of MP that have an important role in coronary instability
to evaluate microRNAs levels variation in Non ST-Elevation Acute Coronary Syndromes NSTE-ACS patients treated with ticagrelor in addition to low or high ASA in comparison with clopidogrelASA treatment and to study possible correlations between microRNAs and MP levels supposing that the ability of ticagrelor in reduced MP level could be related with microRNAs expression
In summary principal hypothesis of the study are
Considering that ticagrelor is a stronger P2Y12 receptor inhibitor than clopidogrel the investigators suppose that an increased inhibition of P2Y12 receptor by ticagrelor could reduce circulating levels of platelet and endothelial MP
In consideration of the observed role of microRNAs in expression of P2Y12 receptor the investigators speculate that patients susceptibility to P2Y12 receptor inhibitors could be influenced by microRNAs levels Moreover the investigators suppose that ticagrelor could influence microRNAs levels considered as marker of cardiovascular risk
Aims of the study are
to assess MP levels variation in Non ST-Elevation Acute Coronary Syndromes NSTE-ACS patients treated with ticagrelor in addition to low or high acetyl-salicylic acid ASA in comparison with clopidogrelASA treatment to demonstrate that major clinical efficacy of ticagrelor could be partially attributed to its influence on release of MP that have an important role in coronary instability
to evaluate microRNAs levels variation in Non ST-Elevation Acute Coronary Syndromes NSTE-ACS patients treated with ticagrelor in addition to low or high ASA in comparison with clopidogrelASA treatment and to study possible correlations between microRNAs and MP levels supposing that the ability of ticagrelor in reduced MP level could be related with microRNAs expression
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