Antiplatelet Therapies in Patients With Depression and Coronary Disease (ENHANCE)

Centro Cardiologico Monzino

Status: Enrolling

Conditions: Coronary Artery Disease; Depression

Treatments: Other: standard ASA therapy; Other: standard Aspirin (ASA) + Ticagrelor (TCG) or Prasugrel (PSG) therapy; Other: standard Aspirin (ASA) + clopidogrel (CLP) therapy

Study type: Observational

Funder types: Other

Identifiers

NCT05821062

CCM 1422

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.

2. 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.

Exclusion criteria

• 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

Trial design

400 participants in 8 patient groups

Group 1a

Description:

CAD patients with depression on standard ASA+CLP therapy.

Treatment:

Other: standard Aspirin (ASA) + clopidogrel (CLP) therapy

Group 1b

Description:

CAD Patients without depression on standard ASA+CLP therapy.

Treatment:

Other: standard Aspirin (ASA) + clopidogrel (CLP) therapy

Group 2a

Description:

CAD patients with depression on standard ASA+TCG/PSG therapy.

Treatment:

Other: standard Aspirin (ASA) + Ticagrelor (TCG) or Prasugrel (PSG) therapy

Group 2b

Description:

CAD patients without depression on standard ASA+TCG/PSG therapy.

Treatment:

Other: standard Aspirin (ASA) + Ticagrelor (TCG) or Prasugrel (PSG) therapy

Group 3a

Description:

CAD patients with depression on standard ASA treatment alone at least 1 month after TCG/PSG cessation.

Treatment:

Other: standard ASA therapy

Group 3b

Description:

CAD patients without depression on standard ASA treatment alone at least 1 month after TCG/PSG cessation.

Treatment:

Other: standard ASA therapy

Group 1c

Description:

Subjects with depression without CAD (DS) are enrolled are enrolled as a comparison group.

Group 1d

Description:

Healthy control subjects (HC), subjects without depression and without CAD are enrolled as a comparison group.