patients with type 2 diabetes mellitus and known coronary artery disease on dual antiplatelet therapy (aspirin 100 mg qd and clopidogrel 75 mg qd) MedDRA version: 14.1 Level: SOC Classification code 10007541 Term: Cardiac disorders System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: PLAVIX*28CPR RIV 75MG
Pharmaceutical Form: Tablet
CAS Number: 113665-84-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Trade Name: BRILIQUE*56CP
Sponsors
UNIVERSITA' CAMPUS BIOMEDICO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: patients with type 2 diabetes mellitus (oral antidiabetic drugs) and known coronary artery disease on dual antiplatelet therapy (aspirin 100 mg qd and clopidogrel 75 mg qd) 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 54
Exclusion criteria
Exclusion criteria: 1. Patients with platelet counts less than 70 × 109 / L 2. Patients undergoing surgery for coronary artery bypass grafting in the previous three months 3. Patients with a recent episode of major bleeding (<6 months) 4. Patients with chronic renal failure, severe (GFR <30 ml / min) 5. Patients with severe left ventricular dysfunction (ejection fraction <30%)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: effects of ticagrelor (90 mg bid) and a high dose of clopidogrel (150 mg qd) on platelet inhibition and endothelial function in diabetic patients receiving maintenance antiplatelet therapy;Secondary Objective: 1. Assessment of endothelial function (FMD and NMD) in the timing of the study in the two treatment groups; 2. Incidence of adverse events during the study.;Primary end point(s): evaluation of residual platelet reactivity in the timing of the study in the two treatment groups.;Timepoint(s) of evaluation of this end point: 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Assessment of endothelial function (FMD and NMD) in the timing of the study in the two treatment groups; 2. Incidence of adverse events during the study.;Timepoint(s) of evaluation of this end point: 30days | — |
Countries
Italy
Contacts
Public ContactCARDIOLOGIA
POLICLINICO UNIVERSITARIO CAMPUS BIO-MEDICO DI ROMA
Outcome results
None listed