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

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ClinicalTrials.gov Identifier: NCT01678339
Recruitment Status : Withdrawn
First Posted : September 5, 2012
Last Update Posted : October 3, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
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 or disease
Acute Coronary Syndrome Acute Myocardial Infarction

Detailed Description:
HEALTH-DB ACS
Study Design
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Sicilian Administrative Data Base Study in Acute Coronary Syndrome Patients
Study Start Date : September 2012
Estimated Study Completion Date : December 2012
Groups and Cohorts
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Group/Cohort
1


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. The chronological analysis of the requirements will allow the identification of potential therapeutic combinations or substitutions. [ Time Frame: up to 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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Italy
Research Site
Palermo, Italy
Sponsors and Collaborators
AstraZeneca
Investigators
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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
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01678339    
Other Study ID Numbers: NIS-CIT-XXX-2012/1
First Posted: September 5, 2012    Key Record Dates
Last Update Posted: October 3, 2012
Last Verified: October 2012
Keywords provided by AstraZeneca:
ACS
AMI
Additional relevant MeSH terms:
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Myocardial Infarction
Acute Coronary Syndrome
Syndrome
Infarction
Disease
Pathologic Processes
 Ischemia
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases