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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02071966
Other study ID # D5130L00028
Secondary ID
Status Terminated
Phase Phase 4
First received February 21, 2014
Last updated July 25, 2016
Start date November 2012
Est. completion date November 2016

Study information

Verified date July 2016
Source Catholic University of the Sacred Heart
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial 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.


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 patient's 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 clopidogrel+ASA 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 clopidogrel+ASA 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.


Recruitment information / eligibility

Status Terminated
Enrollment 55
Est. completion date November 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 50 Years to 80 Years
Eligibility Inclusion Criteria:

- NSTE-ACS

- Male, 50-80 years old

- Female, postmenopausal age

Exclusion Criteria:

- Female, premenopausal age

- autoimmune disease

- infectious disease

- neoplasms

- diabetes

- chronic renal failure

- moderate or severe liver insufficiency

- GRACE risk score>140

- ACS or cerebrovascular accidents in previous three months

- in-stent restenosis

- surgery or trauma in previous three months

- active bleeding

- fibrinolytic therapy within 24 hours before randomization

- need for oral anticoagulation therapy

- an increased risk of bradycardia

- drugs study hypersensitivity (including aspirin)

- co-administration of ticagrelor or clopidogrel with strong CYP3A4 inhibitors

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Ticagrelor
Comparison of Ticagrelor with another anti-platelet drug (Clopidogrel)
Clopidogrel
Comparison of Clopidogrel with another anti-platelet drug (Ticagrelor)

Locations

Country Name City State
Italy Policlinico "A.Gemelli" Rome

Sponsors (1)

Lead Sponsor Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Micro-RNA and microparticles up to three months Yes
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