Antiplatelet Therapies in Patients With Depression and Coronary Disease
NCT ID: NCT05821062
Last Updated: 2023-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
400 participants
OBSERVATIONAL
2022-04-14
2024-02-29
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Group 1a
CAD patients with depression on standard ASA+CLP therapy.
standard Aspirin (ASA) + clopidogrel (CLP) therapy
ASA100mg + CLP 75mg daily
Group 1b
CAD Patients without depression on standard ASA+CLP therapy.
standard Aspirin (ASA) + clopidogrel (CLP) therapy
ASA100mg + CLP 75mg daily
Group 2a
CAD patients with depression on standard ASA+TCG/PSG therapy.
standard Aspirin (ASA) + Ticagrelor (TCG) or Prasugrel (PSG) therapy
ASA 100 mg + TCG 90mg/b.i.d or PSG10mg daily
Group 2b
CAD patients without depression on standard ASA+TCG/PSG therapy.
standard Aspirin (ASA) + Ticagrelor (TCG) or Prasugrel (PSG) therapy
ASA 100 mg + TCG 90mg/b.i.d or PSG10mg daily
Group 3a
CAD patients with depression on standard ASA treatment alone at least 1 month after TCG/PSG cessation.
standard ASA therapy
ASA 100 mg daily
Group 3b
CAD patients without depression on standard ASA treatment alone at least 1 month after TCG/PSG cessation.
standard ASA therapy
ASA 100 mg daily
Group 1c
Subjects with depression without CAD (DS) are enrolled are enrolled as a comparison group.
No interventions assigned to this group
Group 1d
Healthy control subjects (HC), subjects without depression and without CAD are enrolled as a comparison group.
No interventions assigned to this group
Interventions
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standard Aspirin (ASA) + clopidogrel (CLP) therapy
ASA100mg + CLP 75mg daily
standard Aspirin (ASA) + Ticagrelor (TCG) or Prasugrel (PSG) therapy
ASA 100 mg + TCG 90mg/b.i.d or PSG10mg daily
standard ASA therapy
ASA 100 mg daily
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
85 Years
ALL
No
Sponsors
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IRCCS National Neurological Institute "C. Mondino" Foundation
OTHER
Centro Cardiologico Monzino
OTHER
Responsible Party
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Principal Investigators
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Giancarlo Marenzi, MD
Role: PRINCIPAL_INVESTIGATOR
IRCCS Centro Cardiologico Monzino
Locations
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IRCCS Centro Cardiologico Monzino
Milan, , Italy
IRCCS National Neurological Institute "C. Mondino" Foundation
Pavia, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CCM 1422
Identifier Type: -
Identifier Source: org_study_id
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