Depression after an acute coronary syndrome (ACS) but also at any time after CAD diagnosis, is highly associated with death, and it predicts mortality more than any other risk factor, comorbidity or follow-up events, suggesting that the standard medical therapy may not be sufficient to prevent the poor prognosis in these patients. This study aims to assess whether depression might affect the response to dual antiplatelet therapy (DAPT) as recommended in coronary artery disease (CAD) patients. Specific aims: * to evaluate whether depression affects the antithrombotic response during Aspirin (ASA) plus clopidogrel (CLP) therapy in CAD patients. * to assess the antithrombotic effects of ASA plus ticagrelor or prasugrel (TCG/PSG) therapy in CAD patients with depression by evaluating pro-thrombotic phenotype in CAD patients with and without depression during ASA+TCG/PSG. * to assess whether there is or not the reactivation of pro-thrombotic profile after cessation of dual antiplatelet therapy in CAD patients with or without depression in single antiplatelet therapy after TCG/PSG cessation.
This study is a multicentre, prospective, observational, case-control, and cross-sectional study. It is planned to enrol 400 patients/subjects (300 patients at Centro Cardiologico Monzino and 100 subjects at IRCCS National Neurological Institute "C. Mondino" Foundation). Pharmacological treatments in progress will be recorded, administration of Beck Depression Inventory-II (BDI-II), and a fasting blood venous sample (from ante-cubital vein) will be carried out for the haematochemical analyses and for research samples. First morning-urine will be collected for oxidative stress evaluation.
Study Type
OBSERVATIONAL
Enrollment
400
ASA100mg + CLP 75mg daily
ASA 100 mg + TCG 90mg/b.i.d or PSG10mg daily
ASA 100 mg daily
IRCCS Centro Cardiologico Monzino
Milan, Italy
RECRUITINGIRCCS National Neurological Institute "C. Mondino" Foundation
Pavia, Italy
RECRUITINGVerify whether depression affects the platelet response during ASA plus CLP therapy in CAD patients
Measuring platelet activity markers
Time frame: 3 years
Verify whether depression affects the coagulation during ASA plus CLP therapy in CAD patients
Measuring all the parameters of clot formation and lysis collected by thromboelastography analyses
Time frame: 3 years
Verify whether depression affects oxidative stress during ASA plus CLP therapy in CAD patients
Measuring lipid peroxidation
Time frame: 3 years
Assess the effects of ASA plus TCG/PSG therapy on platelet response in CAD patients with depression
Measuring platelet activity markers
Time frame: 3 years
Assess the effects of ASA plus TCG/PSG therapy on coagulation in CAD patients with depression
Measuring all the parameters of clot formation and lysis collected by thromboelastography analyses
Time frame: 3 years
Assess the effects of ASA plus TCG/PSG therapy on oxidative stress in CAD patients with depression
Measuring lipid peroxidation
Time frame: 3 years
Assess whether there is or not the activation of platelet response after cessation of dual antiplatelet therapy in CAD patients with depression
Measuring platelet activity markers
Time frame: 3 years
Assess whether there is or not the activation of coagulation after cessation of dual antiplatelet therapy in CAD patients with depression
Measuring all the parameters of clot formation and lysis collected by thromboelastography analyses
Time frame: 3 years
Assess whether there is or not the activation of oxidative stress after cessation of dual antiplatelet therapy in CAD patients with depression
Measuring lipid peroxidation
Time frame: 3 years
CLP metabolism in patients with depression and CAD
Measuring the CLP active metabolite
Time frame: 3 years
Epigenetic modification in patients with depression and CAD
Through miRNAs analysis
Time frame: 3 years
DNA methylation in patients with depression and CAD
Measuring DNA methylation levels of two 5'-C-phosphate-G-3' (CpG) dinucleotides on P2Y12
Time frame: 3 years
Impact of depression on oxidative stress in patients without CAD
Measuring platelet activity markers
Time frame: 3 years
Effect of depression on oxidative stress in patients without CAD
Measuring lipid peroxidation
Time frame: 3 years
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