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

NCT02071966 | Terminated Phase 4 DMC

• 1 other identifier: D5130L00028
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Non ST Segment Elevation Acute Coronary Syndrome

Keywords

Micro-RNA, Microparticles, Ticagrelor, NSTE-ACS

Outcome Measures

Primary Outcomes (1)

• Micro-RNA and microparticles

  up to three months

Study Arms (2)

Ticagrelor

ACTIVE COMPARATOR

Ticagrelor: oral, 180 mg once for the first dose then 90 mg twice a day

Drug: Ticagrelor

Clopidogrel

ACTIVE COMPARATOR

Clopidogrel: oral, 300 or 600 mg once for the first dose, 75 mg once a day

Drug: Clopidogrel

Interventions

Ticagrelor DRUG

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

Also known as: Brilique

Ticagrelor

Clopidogrel DRUG

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

Also known as: Plavix

Clopidogrel

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• NSTE-ACS
• Male, 50-80 years old
• Female, postmenopausal age

You may not qualify if:

• 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

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Policlinico "A.Gemelli"

Rome, 00168, Italy

Location

MeSH Terms

Interventions

Ticagrelor; Clopidogrel

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Luigi M Biasucci, Professor

  Catholic University of the Sacred Heart

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 21, 2014
• First Posted: February 26, 2014
• Study Start: November 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: November 1, 2016
• Last Updated: July 26, 2016

Record last verified: 2016-07

Locations

IT (1)