patients affected by acute coronary syndrome with plaque erosion phenotype MedDRA version: 20.0 Level: PT Classification code 10051592 Term: Acute coronary syndrome System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Product Name: Brilique
Product Code: NA
Pharmaceutical Form: Orodispersible tablet
INN or Proposed INN: ticagrelor
Current Sponsor code: NA
Concentration unit: mg milligram(s)
Concentration type: equa
Sponsors
FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age >= 18 years; • Admission with acute coronary syndrome (unstable angina, NSTEMI and STEMI); • A residual vessel diameter stenosis of less than 70% and Thrombolysis In Myocardial Infarction (TIMI) flow grade 3 after wiring of the culprit vessel (and thrombus aspiration, if needed); • A diagnosis of plaque erosion by intracoronary OCT imaging of the culprit vessel, with a residual area stenosis 3.5 mm2. • Signed written informed consent to study participation. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 160 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 240
Exclusion criteria
Exclusion criteria: • Age <18 years old; • Left ventricular ejection fraction (LVEF) < 30%; • Hypotension, shock, or need for mechanical circulatory support or intravenous vasopressors; • Contraindication or known hypersensitivity to any of the study drugs (i.e., aspirin, ticagrelor, heparin, and/or colchicine); • Unstable ventricular arrhythmias; • Creatinine clearance < 30 ml/min/1.73 m2 (as calculated by MDRD); • Severe vessel tortuosity or calcification of the culprit vessel, such that it is unlikely that the OCT catheter can be delivered. • The culprit lesion is a stent thrombosis; • Life expectancy < 1 year; • Known history of systemic inflammatory conditions and/or current use or plans to begin chronic systemic steroid therapy (oral or intravenous) during the study (topical or inhaled steroids are allowed); • History of cancer or lymphoproliferative disease within the last 3 years. • Refusal to sign the written informed consent to study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary aim of the study is to determine the non-inferiority of a conservative (CON) strategy of medical therapy alone, including antithrombotic and anti-inflammatory therapies, in ACS patients with plaque erosion phenotype in the 1-year risk of MACEs, as compared with an invasive (INV) strategy of routine early cardiac catheterization and PCI with stenting in addition to optimal medical therapy. MACEs will be defined as the composite of cardiac death, non-fatal myocardial infarction, re-hospitalization due to unstable or progressive angina (according to Braunwald Unstable Angina Classification), and clinically-driven target lesion revascularization.;Secondary Objective: •To determine the short- and long-term safety of CON vs INV strategies in this population. •Comparison of the incidence of the individual components of MACEs; •Comparison of health resource utilization, cost, and cost-effectiveness between the two investigated strategies.;Primary end point(s): The primary endpoint is freedom from MACEs at 12 months. MACEs will be defined as the composite of cardiac death, non-fatal myocardial infarction, re-hospitalization due to unstable or progressive angina (according to Braunwald Unstable Angina Classification), and clinically-driven target lesion revascularization.;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Rates of safety outcomes (stroke and major bleeding) at 12 months [i.e., 1-year incidence of stroke/transient ischemic attack, and of major or clinically-relevant non major bleeding according to BARC definition (i.e., BARC type 2, 3, or 5)]; Every single component of MACEs, previously described; Healthcare primary and secondary related-costs (including costs for tests, procedures and outpatient visits or medicines) and socioeconomic burden in the specific population;Timepoint(s) of evaluation of this end point: 12 months; 12 months; 12 months | — |
Countries
Italy
Contacts
Public ContactDirezione Scientifica
Fondazione Policlinico Universitario A. Gemelli IRCCS
Outcome results
None listed