Antiplatelet Therapies in Patients With Depression and Coronary Disease

NCT05821062 | Unknown

• 1 other identifier: CCM 1422
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 2

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.

Conditions

Coronary Artery Disease; Depression

Keywords

Coronary Artery Disease; Depression; Acetylsalicylic acid; Prasugrel; Ticagrelor; Dual antiplatelet therapy

Outcome Measures

Primary Outcomes (9)

• Verify whether depression affects the platelet response during ASA plus CLP therapy in CAD patients

  Measuring platelet activity markers

  3 years

• Verify whether depression affects the coagulation during ASA plus CLP therapy in CAD patients

  Measuring all the parameters of clot formation and lysis collected by thromboelastography analyses

  3 years

• Verify whether depression affects oxidative stress during ASA plus CLP therapy in CAD patients

  Measuring lipid peroxidation

  3 years

• Assess the effects of ASA plus TCG/PSG therapy on platelet response in CAD patients with depression

  Measuring platelet activity markers

  3 years

• Assess the effects of ASA plus TCG/PSG therapy on coagulation in CAD patients with depression

  Measuring all the parameters of clot formation and lysis collected by thromboelastography analyses

  3 years

• Assess the effects of ASA plus TCG/PSG therapy on oxidative stress in CAD patients with depression

  Measuring lipid peroxidation

  3 years

• Assess whether there is or not the activation of platelet response after cessation of dual antiplatelet therapy in CAD patients with depression

  Measuring platelet activity markers

  3 years

• Assess whether there is or not the activation of coagulation after cessation of dual antiplatelet therapy in CAD patients with depression

  Measuring all the parameters of clot formation and lysis collected by thromboelastography analyses

  3 years

• Assess whether there is or not the activation of oxidative stress after cessation of dual antiplatelet therapy in CAD patients with depression

  Measuring lipid peroxidation

  3 years

Secondary Outcomes (5)

• 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

Study Arms (8)

Group 1a

CAD patients with depression on standard ASA+CLP therapy.

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

Group 1b

CAD Patients without depression on standard ASA+CLP therapy.

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

Group 2a

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

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

Group 2b

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

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

Group 3a

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

Other: standard ASA therapy

Group 3b

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

Other: standard ASA therapy

Group 1c

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

Group 1d

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

Interventions

standard Aspirin (ASA) + clopidogrel (CLP) therapy OTHER

ASA100mg + CLP 75mg daily

Group 1a; Group 1b

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

ASA 100 mg + TCG 90mg/b.i.d or PSG10mg daily

Group 2a; Group 2b

standard ASA therapy OTHER

ASA 100 mg daily

Group 3a; Group 3b

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro Cardiologico Monzino: lead
• IRCCS National Neurological Institute "C. Mondino" Foundation: collaborator

Study Sites (2)

IRCCS Centro Cardiologico Monzino

Milan, 20138, Italy

RECRUITING

IRCCS National Neurological Institute "C. Mondino" Foundation

Pavia, 27100, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

platelet activation, coagulation, lipid peroxidation, CLP active metabolite and epigenetic modifications influencing the response to CLP.

MeSH Terms

Conditions

Coronary Artery Disease; Depression

Interventions

Clopidogrel; cysteine and glycine-rich protein 3; Therapeutics; Ticagrelor; Prasugrel Hydrochloride

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Adenosine; Purine Nucleosides; Purines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Piperazines

Study Officials

• Giancarlo Marenzi, MD

  IRCCS Centro Cardiologico Monzino

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giancarlo Marenzi, MD

CONTACT

02.58002582; Giancarlo.Marenzi@cardiologicomonzino.it

Silvia Stella Barbieri, PhD

CONTACT

02.58002021; silvia.barbieri@cardiologicomonzino.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: April 20, 2023
• Study Start: April 14, 2022
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: April 20, 2023

Record last verified: 2023-04

Locations

IT (2)