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

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2012
INTERVENTION: 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 Concentration number: 180‐ Trade Name: PLAVIX*28CPR RIV 75MG Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: CLOPIDOGREL CAS Number: 113665‐84‐2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75‐ CONDITION: 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 Therapeutic area: Diseases [C] ‐ Cardiovascular Diseases [C14] PRIMARY OUTCOME: 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. Primary end point(s): MP levels variation 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. Timepoint(s) of evaluation of this end point: 3 Months SECONDARY OUTCOME: Secondary end point(s): evaluate microRNAs levels Timepoint(s) of evaluation of this end point: 3 Months 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
Epistemonikos ID: 4b343920e6052ede5ab64fe7bf9efde349979c44
First added on: Aug 22, 2024