CLOpidogrel versus TIcagreLor for reduction of platelet reacivity during dual antiplatelet therapy in DIAbetic patients underwent coroNary angioplasty(CLOTILDIA)

Conditions: 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: 14.1Level: SOCClassification code 10007541Term: Cardiac disordersSystem Organ Class: 10007541 - Cardiac disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2012-004770-25-IT

Lead Sponsor: IVERSITA' CAMPUS BIOMEDICO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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%)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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;<br>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 Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Assessment of endothelial function (FMD and NMD) in the timing of the study in the two treatment groups;<br>2. Incidence of adverse events during the study.;Timepoint(s) of evaluation of this end point: 30days