Study of Effects of Ticagrelor on Microparticles and Micro-RNA in NSTE-ACS

• Status: Terminated
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Catholic University of the Sacred Heart
• Treatments: Clopidogrel; Ticagrelor; Ticlopidine

Criteria

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