Clinical trial NCT05821062: Antiplatelet Therapies in Patients With Depression and Coronary Disease
Official title: Effect of Antiplatelet Therapies in Patients With Depression and Coronary Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Depression
Keywords: Coronary Artery Disease
Depression
Acetylsalicylic acid
Prasugrel
Ticagrelor
Dual antiplatelet therapy
Lead sponsor: Centro Cardiologico Monzino
Sponsor class: OTHER
Collaborators: name: IRCCS National Neurological Institute "C. Mondino" Foundation
First posted: 2023-04-20
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The population of this study includes patients/subjects with or without depression, with CAD (to be enrolled at Centro Cardiologico Monzino) and without CAD (to be enrolled at IRCCS National Neurological Institute "C. Mondino" Foundation)

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Verify whether depression affects the platelet response during ASA plus CLP therapy in CAD patients
timeFrame: 3 years
measure: Verify whether depression affects the coagulation during ASA plus CLP therapy in CAD patients
timeFrame: 3 years
measure: Verify whether depression affects oxidative stress during ASA plus CLP therapy in CAD patients
timeFrame: 3 years
measure: Assess the effects of ASA plus TCG/PSG therapy on platelet response in CAD patients with depression
timeFrame: 3 years
measure: Assess the effects of ASA plus TCG/PSG therapy on coagulation in CAD patients with depression
timeFrame: 3 years
measure: Assess the effects of ASA plus TCG/PSG therapy on oxidative stress in CAD patients with depression
timeFrame: 3 years
measure: Assess whether there is or not the activation of platelet response after cessation of dual antiplatelet therapy in CAD patients with depression
timeFrame: 3 years
measure: Assess whether there is or not the activation of coagulation after cessation of dual antiplatelet therapy in CAD patients with depression
timeFrame: 3 years
measure: Assess whether there is or not the activation of oxidative stress after cessation of dual antiplatelet therapy in CAD patients with depression
timeFrame: 3 years
Secondary outcomes:
measure: CLP metabolism in patients with depression and CAD
timeFrame: 3 years
measure: Epigenetic modification in patients with depression and CAD
timeFrame: 3 years
measure: DNA methylation in patients with depression and CAD
timeFrame: 3 years
measure: Impact of depression on oxidative stress in patients without CAD
timeFrame: 3 years
measure: Effect of depression on oxidative stress in patients without CAD
timeFrame: 3 years
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Centro Cardiologico Monzino
city: Pavia
country: Italy
facility: IRCCS National Neurological Institute "C. Mondino" Foundation
Study officials:
affiliation: IRCCS Centro Cardiologico Monzino
name: Giancarlo Marenzi, MD
role: PRINCIPAL_INVESTIGATOR
References: