Sicilian Administrative Data Base Study in Acute Coronary Syndrome Patients

NCT01678339 | Withdrawn

• 1 other identifier: NIS-CIT-XXX-2012/1
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome; Acute Myocardial Infarction

Keywords

ACS; AMI

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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

  up to 2 years

• The chronological analysis of the requirements will allow the identification of potential therapeutic combinations or substitutions.

  up to 2 years

Study Arms (1)

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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".

You may qualify if:

• Subjects discharged alive from hospitalization for ACS

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Palermo, Italy

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Flore La Tour

  AstraZeneca CLINICAL RESEARCH DIRECTOR

  STUDY CHAIR

• Raffaele Sabia

  AstraZeneca Italy - VP MEDICAL

  STUDY DIRECTOR

• Rosalia Traiana, Doctor of Pharmacology

  Department of Pharmaceutical Health - SICILIAN REGION

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2012
• First Posted: September 5, 2012
• Study Start: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: October 3, 2012

Record last verified: 2012-10

Locations

IT (1)