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Effects of TIcaGREloR on Circulating Microparticles and Micro-RNAs in patients with Non ST Elevation Acute Coronary Syndromes

Effects of TIcaGREloR on Circulating Microparticles and Micro-RNAs in patients with Non ST Elevation Acute Coronary Syndromes - TIGER-M study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-003897-21-IT
Enrollment
Unknown
Registered
2012-12-28
Start date
2013-03-17
Completion date
Unknown
Last updated
2016-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non ST Elevation Acute Coronary Syndromes MedDRA version: 14.1 Level: PT Classification code 10051592 Term: Acute coronary syndrome System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: BRILIQUE*60CPR RIV 90MG Pharmaceutical Form: Film-coated tablet INN or Proposed INN: TICAGRELOR CAS Number: 274693-27-5 Concentration unit: mg milligram(s) Concentration type: equal Concen

Sponsors

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -PATIENT WITH NON-ST ELEVATION ACUTE CORONARY SYNDROMES - men aged between 50 and 80 years - postmenopausal women Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: men aged 80 years - impossibility to give informed consent - women of childbearing age - diabetes mellitus - severe renal failure (CrCl 140 In stent restenosis

Design outcomes

Primary

MeasureTime frame
Primary end point(s): MP levels variation;Timepoint(s) of evaluation of this end point: 3 Months;Main Objective: 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.;Secondary Objective: - 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 correlation between microRNAs and MP levels, supposing that the ability of ticagrelor in reduced MP level could be related with microRNAs expression.—

Secondary

MeasureTime frame
Secondary end point(s): evaluate microRNAs levels;Timepoint(s) of evaluation of this end point: 3 Months—

Countries

Italy

Contacts

Public ContactTERAPIA SUBINTENSIVA CARDIOLOGICA

POLICLINICO GEMELLI

LMARZIO.BIASUCCI@RM.UNICATT.IT0630154109

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026