Sicilian Administrative Data Base Study in Acute Coronary Syndrome Patients (HEALTH-DB ACS)

October 2, 2012 updated by: AstraZeneca
Thi is an observational, non interventional, cohort analysis by using administrative databases (drugs treatment, laboratory and diagnostic tests, specialist visits and hospitalizations) of Sicilia region to evaluate treatment patterns of patients after Acute Coronary Syndrome (ACS) event.

Study Overview

Status

Withdrawn

Conditions

Detailed Description

HEALTH-DB ACS

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Palermo, Italy
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients discharged alive from an hospitalization for Acute Myocardial Infarction (AMI) between January, 1st 2008 and December, 31st 2010 (inclusion period) will be included into analysis. The discharge date will be defined as "inclusion date".

Description

Inclusion Criteria:

  • Subjects discharged alive from hospitalization for ACS

Exclusion Criteria:

  • All patients that don't have a continuative presence as beneficiaries of the region between January 1st, 2007 and December 31st 2011 will be excluded from analysis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The diagnostic path for each patient included in the analysis will be described by using all prescription for laboratory test (eg. total cholesterol, LDL cholesterol) and/or diagnostics tests (eg. electrocardiogram) during the observation period.
Time Frame: up to 2 years
up to 2 years
The drugs treatment path will be described by using all prescriptions of antihypertensive drugs, lipid-lowering drugs and antiplatelet drugs during the observation period.
Time Frame: up to 2 years
up to 2 years
Adherence to treatment will be calculated in the manner suggested by the literature and used in previous publications. Different methods of assessment will, however, used in order to study the variability of results. The analysis will be conducted over
Time Frame: up to 2 years
up to 2 years
The chronological analysis of the requirements will allow the identification of potential therapeutic combinations or substitutions.
Time Frame: up to 2 years
up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Chair: Flore La Tour, AstraZeneca CLINICAL RESEARCH DIRECTOR
  • Study Director: Raffaele Sabia, AstraZeneca Italy - VP MEDICAL
  • Principal Investigator: Rosalia Traiana, Doctor of Pharmacology, Department of Pharmaceutical Health - SICILIAN REGION

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion

December 7, 2022

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

August 23, 2012

First Submitted That Met QC Criteria

August 31, 2012

First Posted (Estimate)

September 5, 2012

Study Record Updates

Last Update Posted (Estimate)

October 3, 2012

Last Update Submitted That Met QC Criteria

October 2, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-CIT-XXX-2012/1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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