Study Evaluating How Patients With Acute Coronary Syndrome Are Managed During 2 Years After Discharge

Completed

• Conditions: ACS; Acute Coronary Syndrome; Myocardial Infarction; Unstable Angina; Coronary Artery Disease

• Registration Number: NCT01171404
• Lead Sponsor: AstraZeneca

Brief Summary

The aim of this international study is to describe the short- and long-term (i.e. up to 2 years following the index event) antithrombotic management patterns (AMPs) in patients hospitalized for acute coronary syndromes (ST segment elevation myocardial infarction (STEMI), Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS)), and to document the impact of AMPs in clinical outcomes, economic variables and quality of life in a 'real-life' setting and to compare these between sites, countries and regions.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-27
• Study First Submitted QC: 2010-07-27
• Study First Posted: 2010-07-28
• Study Start: 2010-09
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-16
• Last Update Posted: 2013-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10568

Inclusion Criteria

• Diagnosis of myocardial infarction or unstable angina
• Hospitalized for the first time within 24 hours of onset of symptoms

Exclusion Criteria

• Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker or does not understand the local language, psychiatric disturbances)
• Current participation in a clinical trial.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical outcomes (ischemic and bleeding) incidence and time to these clinical outcomes	Longitudinal during 2 years after index event (phone calls to the patients at 6 weeks and each 3 months after index event)

Secondary Outcome Measures

Name	Time	Method
Antithrombotic treatments	Longitudinal during 2 years after index event (phone calls to the patients at 6 weeks and each 3 months after index event)
Use of health care resources	Longitudinal during 2 years after index event (phone calls to the patients at 6 weeks and each 3 months after index event)
Quality of life	At index event (baseline) and then at 6 weeks and each 3 months after index event

Trial Locations

Locations (1)

Research Site; 🇻🇪 Valencia, Venezuela