Platelets Count Alterations in Patients With Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

Official title:

Platelets Count Alterations in Patients With Acute Coronary Syndrome: Epidemiology and Prognostic Role

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03583411
• Other study ID #: S_23_10_17_2001
• Status: Completed
• Start date: June 25, 2018
• Est. completion date: May 17, 2019

Study information

• Verified date: May 2019
• Source: Niguarda Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Platelet count alterations (thrombocytopenia and thrombocytosis) are a common condition in patients hospitalised for acute coronary syndrome (ACS), both at disease onset and in the following recovery phase.1-3 Different factors can explain this phenomenon. Thrombocytopenia could be either due to neurohormonal activation and the inflammatory process following myocardial necrosis leading to increased macrophage activation with increased clearance of platelets, or to an immuno-modulated mechanism caused by the administration of antiaggregant/anticoagulant drugs (heparin, glycoprotein IIb/IIIa inhibitors, P2Y12 inhibitors).

Even the invasive treatment of coronaropathy during hospitalization, with angioplasty and stent implantation procedures and/or the eventual implantation of temporary mechanical blood circulation assistant devices [aortic counterpulsation, Impella, ECMO (Extracorporeal Membrane Oxygenation)], could further favour the phenomenon.4 Vice versa, thrombocytosis occurring during ACS has a reactive origin, caused by increased IL-6 production which, in turn, leads to an increase in thrombopoietin formation in the liver, causing a consequent stimulatory activity on megakaryocytes.2 Different studies have demonstrated a significant correlation between platelets count disorders and patient outcome (survival during hospitalization and in the immediate follow-up).5-11 This association has, however, often been considered an epiphenomenon of the underlying pathology. Platelets count alterations are, indeed, usually consensual to other hemogram alterations (anaemia and neutropenia), an indication of a coexisting medullar insufficiency (thrombocytopenia) or other heterogenous diseases such as cancer, iron deficiency or immuno-modulated diseases, usually associated with an increase in comorbidity indexes.12 Those alterations, moreover, can usually influence changes to the therapeutic approach (reduction/suspension of recommended standard therapies) and further condition the prognosis.13 Since a few years, the investigators have been established a cardiac-haematological collaboration aiming at finding early alterations in platelets count or, more generally, in cell blood count (CBC), collegially evaluating those alterations with a cardiologist and a haematologist (even in mild cases) and scheduling, on the basis of the aforementioned evaluations, a more precise and tailored therapeutic approach toward the specific patient needs in order to minimize the downgrading of potentially life-saving therapies.14 Until now, however, no precise evaluation of the impact that this strategy had in influencing the therapeutic approach and in improving patient outcome in our population has been performed.

A retrospective evaluation of consecutive ACS patients, their clinical, biohumoral and procedural characteristics and the adopted pharmacological treatments is, therefore, an important epidemiologic tool for the characterization of this phenomenon and for identifying potential associations which could suggest possible future therapeutic developments.

Description:

Even the invasive treatment of coronaropathy during hospitalization, with angioplasty and stent implantation procedures and/or the eventual implantation of temporary mechanical blood circulation assistant devices [aortic counterpulsation, Impella, ECMO (Extracorporeal Membrane Oxygenation)], could further favour the phenomenon. Vice versa, thrombocytosis occurring during ACS has a reactive origin, caused by increased IL-6 production which, in turn, leads to an increase in thrombopoietin formation in the liver, causing a consequent stimulatory activity on megakaryocytes. Different studies have demonstrated a significant correlation between platelets count disorders and patient outcome (survival during hospitalization and in the immediate follow-up). This association has, however, often been considered an epiphenomenon of the underlying pathology. Platelets count alterations are, indeed, usually consensual to other hemogram alterations (anaemia and neutropenia), an indication of a coexisting medullar insufficiency (thrombocytopenia) or other heterogenous diseases such as cancer, iron deficiency or immuno-modulated diseases, usually associated with an increase in comorbidity indexes. Those alterations, moreover, can usually influence changes to the therapeutic approach (reduction/suspension of recommended standard therapies) and further condition the prognosis. Since a few years,the investigators have been established a cardiac-haematological collaboration aiming at finding early alterations in platelets count or, more generally, in cell blood count (CBC), collegially evaluating those alterations with a cardiologist and a haematologist (even in mild cases) and scheduling, on the basis of the aforementioned evaluations, a more precise and tailored therapeutic approach toward the specific patient needs in order to minimize the downgrading of potentially life-saving therapies. Until now, however, no precise evaluation of the impact that this strategy had in influencing the therapeutic approach and in improving patient outcome in our population has been performed.

A retrospective evaluation of consecutive ACS patients, their clinical, biohumoral and procedural characteristics and the adopted pharmacological treatments is, therefore, an important epidemiologic tool for the characterization of this phenomenon and for identifying potential associations which could suggest possible future therapeutic developments.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: May 17, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All consecutive ACS subjects hospitalized in the Cardiology 1 - UTIC department of ASST Grande Ospedale Metropolitano Niguarda between 2014 and 2017

Exclusion Criteria:

• Age <18 years

• Subjects admitted with ACS diagnosis but not confirmed at discharge

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Other:
• Epidemiological data collection
To profile each subject enrolled in the study, anamnesis and different personal, clinical, procedural, pharmacological and follow up related variables will be collected. Data collection, maintenance and analysis will be performed using a database that will be developed, managed and updated by study promoter, in accordance with Good Clinical Practice (GCP)

Locations

Country	Name	City	State
Italy	Azienda Opsedaliera Ospedale Niguarda Ca' Granda	Milano	MI

Sponsors (1)

Lead Sponsor	Collaborator
Niguarda Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Morici N, Tavecchia GA, Antolini L, Caporale MR, Cantoni S, Bertuccio P, Sacco A, Meani P, Viola G, Brunelli D, Oliva F, Lombardi F, Segreto A, Oreglia JA, La Vecchia C, Cattaneo M, Valgimigli M, Savonitto S. Use of PRECISE-DAPT Score and Admission Platelet Count to Predict Mortality Risk in Patients With Acute Coronary Syndrome. Angiology. 2019 May 14:3319719848547. doi: 10.1177/0003319719848547. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	net adverse clinical events NACE	the composite of a list of clinical events	2014 to 2017
Secondary	death	patient's death for all causes at follow up	2014 to 2017
Secondary	hospitalization	duration of patient's hospitalization	2014 to 2017