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| Name | Class |
|---|---|
| IRCCS National Neurological Institute "C. Mondino" Foundation | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1a | CAD patients with depression on standard ASA+CLP therapy. |
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| Group 1b | CAD Patients without depression on standard ASA+CLP therapy. |
| |
| Group 2a | CAD patients with depression on standard ASA+TCG/PSG therapy. |
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| Group 2b | CAD patients without depression on standard ASA+TCG/PSG therapy. |
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| Group 3a | CAD patients with depression on standard ASA treatment alone at least 1 month after TCG/PSG cessation. |
| |
| Group 3b | CAD patients without depression on standard ASA treatment alone at least 1 month after TCG/PSG cessation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard Aspirin (ASA) + clopidogrel (CLP) therapy | Other | ASA100mg + CLP 75mg daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| CLP metabolism in patients with depression and CAD | Measuring the CLP active metabolite | 3 years |
| Epigenetic modification in patients with depression and CAD | Through miRNAs analysis |
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Inclusion Criteria:
Centro Cardiologico Monzino: Patients/subjects of both sexes, aged between 18 and 85 years with or without depression, with CAD:
IRCCS National Neurological Institute "C. Mondino" Foundation:
Exclusion Criteria:
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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)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giancarlo Marenzi, MD | Contact | 02.58002582 | Giancarlo.Marenzi@cardiologicomonzino.it | |
| Silvia Stella Barbieri, PhD | Contact | 02.58002021 | silvia.barbieri@cardiologicomonzino.it |
| Name | Affiliation | Role |
|---|---|---|
| Giancarlo Marenzi, MD | IRCCS Centro Cardiologico Monzino | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Centro Cardiologico Monzino | Recruiting | Milan | 20138 | Italy |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| C090114 | cysteine and glycine-rich protein 3 |
| D013812 | Therapeutics |
| D000077486 | Ticagrelor |
| D000068799 | Prasugrel Hydrochloride |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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platelet activation, coagulation, lipid peroxidation, CLP active metabolite and epigenetic modifications influencing the response to CLP.
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| 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. |
| standard Aspirin (ASA) + Ticagrelor (TCG) or Prasugrel (PSG) therapy | Other | ASA 100 mg + TCG 90mg/b.i.d or PSG10mg daily |
|
| standard ASA therapy | Other | ASA 100 mg daily |
|
| 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 |
| 3 years |
| 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 |
| Impact of depression on oxidative stress in patients without CAD | Measuring platelet activity markers | 3 years |
| Effect of depression on oxidative stress in patients without CAD | Measuring lipid peroxidation | 3 years |
| IRCCS National Neurological Institute "C. Mondino" Foundation | Recruiting | Pavia | 27100 | Italy |
|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D010879 | Piperazines |