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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01678339
First Posted: September 5, 2012
Last Update Posted: October 3, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
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.

Condition
Acute Coronary Syndrome Acute Myocardial Infarction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Sicilian Administrative Data Base Study in Acute Coronary Syndrome Patients

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]
  • 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 ]
  • 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 ]
  • The chronological analysis of the requirements will allow the identification of potential therapeutic combinations or substitutions. [ Time Frame: up to 2 years ]

Enrollment: 0
Study Start Date: September 2012
Estimated Study Completion Date: December 2012

Detailed Description:
HEALTH-DB ACS
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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".
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01678339


Locations
Italy
Research Site
Palermo, Italy
Sponsors and Collaborators
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
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01678339     History of Changes
Other Study ID Numbers: NIS-CIT-XXX-2012/1
First Submitted: August 23, 2012
First Posted: September 5, 2012
Last Update Posted: October 3, 2012
Last Verified: October 2012

Keywords provided by AstraZeneca:
ACS
AMI

Additional relevant MeSH terms:
Syndrome
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Disease
Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases