Antiplatelet Therapies in Patients With Depression and Coronary Disease

Depression Clinical Trial

— ENHANCE  

Official title:

Effect of Antiplatelet Therapies in Patients With Depression and Coronary Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05821062
• Other study ID #: CCM 1422
• Status: Recruiting
• Start date: April 14, 2022
• Est. completion date: February 2024

Study information

• Verified date: April 2023
• Source: Centro Cardiologico Monzino
• Contact: Giancarlo Marenzi, MD
• Phone: 02.58002582
• Email: Giancarlo.Marenzi[@]cardiologicomonzino.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Depression
• Depressive Disorder
• Myocardial Ischemia

Intervention

Other:
• 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

Locations

Country	Name	City	State
Italy	IRCCS Centro Cardiologico Monzino	Milan
Italy	IRCCS National Neurological Institute "C. Mondino" Foundation	Pavia

Sponsors (2)

Lead Sponsor	Collaborator
Centro Cardiologico Monzino	IRCCS National Neurological Institute "C. Mondino" Foundation

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Verify whether depression affects the platelet response during ASA plus CLP therapy in CAD patients	Measuring platelet activity markers	3 years
Primary	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
Primary	Verify whether depression affects oxidative stress during ASA plus CLP therapy in CAD patients	Measuring lipid peroxidation	3 years
Primary	Assess the effects of ASA plus TCG/PSG therapy on platelet response in CAD patients with depression	Measuring platelet activity markers	3 years
Primary	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
Primary	Assess the effects of ASA plus TCG/PSG therapy on oxidative stress in CAD patients with depression	Measuring lipid peroxidation	3 years
Primary	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
Primary	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
Primary	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	CLP metabolism in patients with depression and CAD	Measuring the CLP active metabolite	3 years
Secondary	Epigenetic modification in patients with depression and CAD	Through miRNAs analysis	3 years
Secondary	DNA methylation in patients with depression and CAD	Measuring DNA methylation levels of two 5'-C-phosphate-G-3' (CpG) dinucleotides on P2Y12	3 years
Secondary	Impact of depression on oxidative stress in patients without CAD	Measuring platelet activity markers	3 years
Secondary	Effect of depression on oxidative stress in patients without CAD	Measuring lipid peroxidation	3 years