NCT05821062

Antiplatelet Therapies in Patients With Depression and Coronary Disease

Effect of Antiplatelet Therapies in Patients With Depression and Coronary Disease

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Centro Cardiologico Monzino · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Coronary Artery Disease
• Depression

Interventions

Type	Name	Description
OTHER	standard Aspirin (ASA) + clopidogrel (CLP) therapy	ASA100mg + CLP 75mg daily
OTHER	standard Aspirin (ASA) + Ticagrelor (TCG) or Prasugrel (PSG) therapy	ASA 100 mg + TCG 90mg/b.i.d or PSG10mg daily
OTHER	standard ASA therapy	ASA 100 mg daily

Timeline

• Start date: 2022-04-14
• Primary completion: 2024-02-01
• Completion: 2024-02-01
• First posted: 2023-04-20
• Last updated: 2023-04-20

Locations

2 sites across 1 country: Italy