Effect of Antiplatelet Therapies in Patients With Depression and Coronary Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Verify whether depression affects the platelet response during ASA plus CLP therapy in CAD patients
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Centro Cardiologico Monzino: Patients/subjects of both sexes, aged between 18 and 85 years with or without depression, with CAD:
- •Group 1: CAD patients in ASA+CLP (100mg+75mg/daily) therapy with the absence of acute coronary symptoms for at least 5 months.
- •Group 2: CAD patients in ASA+TCG/PSG (TCG:90mg/b.i.d or PSG:10mg/daily) therapy, at least 6 months after ACS.
- •Group 3: CAD patients during ASA treatment alone at least 1 month after TCG/PSG cessation.
- •IRCCS National Neurological Institute "C. Mondino" Foundation:
- •Group 1: Patients/subjects of both sexes, aged between 18 and 85 years with or without depression, without CAD.
排除标准
- •severe chronic heart failure (NYHA class III/IV)
- •severe concomitant valvular disease
- •infectious pathologies
- •autoimmune diseases
- •haematological diseases
- •serious kidney or liver failure
- •positive anamnesis for current or previous neoplasia in the 5 years prior to enrolment
- •positive anamnesis for major traumas and/or surgery in the 6 months prior to enrolment
- •taking immunosuppressive drugs
- •taking of anti-inflammatory drugs
- •taking of antidepressant drugs
- •presence of dementia and psychiatric disorders other than depression
- •Coronavirus disease-19 (COVID-19) swab positive
结局指标
主要结局
Verify whether depression affects the platelet response during ASA plus CLP therapy in CAD patients
时间窗: 3 years
Measuring platelet activity markers
Assess the effects of ASA plus TCG/PSG therapy on coagulation in CAD patients with depression
时间窗: 3 years
Measuring all the parameters of clot formation and lysis collected by thromboelastography analyses
Assess the effects of ASA plus TCG/PSG therapy on oxidative stress in CAD patients with depression
时间窗: 3 years
Measuring lipid peroxidation
Assess whether there is or not the activation of platelet response after cessation of dual antiplatelet therapy in CAD patients with depression
时间窗: 3 years
Measuring platelet activity markers
Assess whether there is or not the activation of coagulation after cessation of dual antiplatelet therapy in CAD patients with depression
时间窗: 3 years
Measuring all the parameters of clot formation and lysis collected by thromboelastography analyses
Assess whether there is or not the activation of oxidative stress after cessation of dual antiplatelet therapy in CAD patients with depression
时间窗: 3 years
Measuring lipid peroxidation
Verify whether depression affects the coagulation during ASA plus CLP therapy in CAD patients
时间窗: 3 years
Measuring all the parameters of clot formation and lysis collected by thromboelastography analyses
Assess the effects of ASA plus TCG/PSG therapy on platelet response in CAD patients with depression
时间窗: 3 years
Measuring platelet activity markers
Verify whether depression affects oxidative stress during ASA plus CLP therapy in CAD patients
时间窗: 3 years
Measuring lipid peroxidation
次要结局
- CLP metabolism in patients with depression and CAD(3 years)
- Epigenetic modification in patients with depression and CAD(3 years)
- DNA methylation in patients with depression and CAD(3 years)
- Impact of depression on oxidative stress in patients without CAD(3 years)
- Effect of depression on oxidative stress in patients without CAD(3 years)