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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01678339
First received: August 23, 2012
Last updated: October 2, 2012
Last verified: October 2012
  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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • The chronological analysis of the requirements will allow the identification of potential therapeutic combinations or substitutions. [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]

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

Detailed Description:

HEALTH-DB ACS

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01678339     History of Changes
Other Study ID Numbers: NIS-CIT-XXX-2012/1
Study First Received: August 23, 2012
Last Updated: October 2, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by AstraZeneca:
ACS
AMI

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014