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NCT01678339 Clinical Trial

Sicilian Administrative Data Base Study in Acute Coronary Syndrome Patients

Acute Coronary Syndrome Clinical Trial

— HEALTH-DB ACS  

Official title:
Sicilian Administrative Data Base Study in Acute Coronary Syndrome Patients

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01678339
Other study ID # NIS-CIT-XXX-2012/1
Secondary ID
Status Withdrawn
Phase N/A
First received August 23, 2012
Last updated October 2, 2012
Start date September 2012
Est. completion date December 2012

Study information
Verified date October 2012
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Observational

Clinical Trial 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.

Description:

HEALTH-DB ACS

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2012
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Research Site Palermo

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Primary 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 No
Primary 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 No
Primary The chronological analysis of the requirements will allow the identification of potential therapeutic combinations or substitutions. up to 2 years No
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