Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05821062
Status:
RECRUITING
Last Update Posted:
2023-04-20
First Post:
2023-03-08
Brief Title:
Antiplatelet Therapies in Patients With Depression and Coronary Disease
Sponsor:
Centro Cardiologico Monzino
Organization:
Centro Cardiologico Monzino
Study Overview
Official Title:
Effect of Antiplatelet Therapies in Patients With Depression and Coronary Disease
Status:
RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENHANCE
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 TCGPSG therapy in CAD patients with depression by evaluating pro-thrombotic phenotype in CAD patients with and without depression during ASATCGPSG
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 TCGPSG cessation
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 TCGPSG therapy in CAD patients with depression by evaluating pro-thrombotic phenotype in CAD patients with and without depression during ASATCGPSG
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 TCGPSG cessation
Detailed Description:
This study is a multicentre prospective observational case-control and cross-sectional study It is planned to enrol 400 patientssubjects 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None