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Coronary Artery DiseaseENHANCENCT05821062

Antiplatelet Therapies in Patients With Depression and Coronary Disease

An observational study of Coronary Artery Disease and Depression, run by Centro Cardiologico Monzino at 2 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Coronary Artery Disease, Depression
What is being tested?
standard Aspirin (ASA) + clopidogrel (CLP) therapy, standard Aspirin (ASA) + Ticagrelor (TCG) or Prasugrel (PSG) therapy and standard ASA therapy
How many people
400 participants
Where
2 sitesItaly
Study dates
14 Apr 2022to Feb 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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)

Who may be able to join

  • 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.

Who cannot join

  • severe chronic heart failure (NYHA class III/IV)
  • severe concomitant valvular disease
  • infectious pathologies
  • autoimmune diseases
  • haematological diseases
  • serious kidney or liver failure
Show all 13Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Giancarlo Marenzi, MD contact

02.58002582

Giancarlo.Marenzi@cardiologicomonzino.it

Silvia Stella Barbieri, PhD contact

02.58002021

silvia.barbieri@cardiologicomonzino.it

Italy2 sites, 2 recruiting

  • IRCCS Centro Cardiologico Monzino

    Milan, 20138

    Giancarlo Marenzi, MD, 02.58002582, giancarlo.marenzi@cardiologicomonzino.it

    Silvia Stella Barbieri, PhD, 02.58002021, silvia.barbieri@cardiologicomonzino.it

    Recruiting

  • IRCCS National Neurological Institute "C. Mondino" Foundation

    Pavia, 27100

    Giulia Perini, MD, 0382.380343, giulia.perini@mondino.it

    Recruiting

Other trials in Italy

About this study

Official title: Effect of Antiplatelet Therapies in Patients With Depression and Coronary Disease

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.

Read more

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.
Read the 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.

Being tested
standard Aspirin (ASA) + clopidogrel (CLP) therapy, standard Aspirin (ASA) + Ticagrelor (TCG) or Prasugrel (PSG) therapy, standard ASA therapy
Keywords
Coronary Artery Disease, Depression, Acetylsalicylic acid, Prasugrel, Ticagrelor, Dual antiplatelet therapy
Medical subject headings
Coronary Artery Disease, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • standard Aspirin (ASA) + clopidogrel (CLP) therapyOther

    ASA100mg + CLP 75mg daily

  • standard Aspirin (ASA) + Ticagrelor (TCG) or Prasugrel (PSG) therapyOther

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

  • standard ASA therapyOther

    ASA 100 mg daily

Study groups in NCT05821062
Study groupRoleWhat they receive
Group 1aCAD patients with depression on standard ASA+CLP therapy.
Receives: Other: standard Aspirin (ASA) + clopidogrel (CLP) therapy
Group 1bCAD Patients without depression on standard ASA+CLP therapy.
Receives: Other: standard Aspirin (ASA) + clopidogrel (CLP) therapy
Group 2aCAD patients with depression on standard ASA+TCG/PSG therapy.
Receives: Other: standard Aspirin (ASA) + Ticagrelor (TCG) or Prasugrel (PSG) therapy
Group 2bCAD patients without depression on standard ASA+TCG/PSG therapy.
Receives: Other: standard Aspirin (ASA) + Ticagrelor (TCG) or Prasugrel (PSG) therapy
Group 3aCAD patients with depression on standard ASA treatment alone at least 1 month after TCG/PSG cessation.
Receives: Other: standard ASA therapy
Group 3bCAD patients without depression on standard ASA treatment alone at least 1 month after TCG/PSG cessation.
Receives: Other: standard ASA therapy
Group 1cSubjects with depression without CAD (DS) are enrolled are enrolled as a comparison group.
Group 1dHealthy control subjects (HC), subjects without depression and without CAD are enrolled as a comparison group.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measuring platelet activity markers

    Measured: 3 years

  2. 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

    Measured: 3 years

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

    Measuring lipid peroxidation

    Measured: 3 years

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

    Measuring platelet activity markers

    Measured: 3 years

  5. 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

    Measured: 3 years

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

    Measuring lipid peroxidation

    Measured: 3 years

  7. 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

    Measured: 3 years

  8. 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

    Measured: 3 years

  9. 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

    Measured: 3 years

Secondary outcomes (5)

  1. CLP metabolism in patients with depression and CAD

    Measuring the CLP active metabolite

    Measured: 3 years

  2. Epigenetic modification in patients with depression and CAD

    Through miRNAs analysis

    Measured: 3 years

  3. DNA methylation in patients with depression and CAD

    Measuring DNA methylation levels of two 5'-C-phosphate-G-3' (CpG) dinucleotides on P2Y12

    Measured: 3 years

  4. Impact of depression on oxidative stress in patients without CAD

    Measuring platelet activity markers

    Measured: 3 years

  5. Effect of depression on oxidative stress in patients without CAD

    Measuring lipid peroxidation

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2023
  2. Study start14 Apr 2022
  3. Primary completionFeb 2024 (estimated)
  4. Study completionFeb 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05821062
Sponsor's protocol ID
CCM 1422
Acronym
ENHANCE
Status last verified
Apr 2023
First submitted
8 Mar 2023
Last updated
20 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Depression, run by Centro Cardiologico Monzino at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Giancarlo Marenzi, MD (02.58002582, Giancarlo.Marenzi@cardiologicomonzino.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Verify whether depression affects the platelet response during ASA plus CLP therapy in CAD patients (time frame: 3 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05821062.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2023.

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