Study Evaluating How Patients With Acute Coronary Syndrome Are Managed During 2 Years After Discharge - Full Text View

Sponsor:	AstraZeneca
Information provided by (Responsible Party):	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01171404

Purpose

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.

Condition
ACS Acute Coronary Syndrome Myocardial Infarction Unstable Angina Coronary Artery Disease

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Long-term Follow-up of Antithrombotic Management Patterns in Acute Coronary Syndrome Patients

Resource links provided by NLM:

MedlinePlus related topics: Angina Coronary Artery Disease Heart Attack

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Clinical outcomes (ischemic and bleeding) incidence and time to these clinical outcomes [ Time Frame: Longitudinal during 2 years after index event (phone calls to the patients at 6 weeks and each 3 months after index event) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Antithrombotic treatments [ Time Frame: Longitudinal during 2 years after index event (phone calls to the patients at 6 weeks and each 3 months after index event) ] [ Designated as safety issue: No ]
Use of health care resources [ Time Frame: Longitudinal during 2 years after index event (phone calls to the patients at 6 weeks and each 3 months after index event) ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: At index event (baseline) and then at 6 weeks and each 3 months after index event ] [ Designated as safety issue: No ]

Estimated Enrollment:	10600
Study Start Date:	September 2010
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Patients, older than 18, hospitalized within 24 hours of onset of symptoms and diagnosed with UA, STEMI or NSTEMI

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients hospitalized within 24 hours of onset of symptoms and diagnosed with unstable angina (UA), STEMI or non-STEMI(NSTEMI). Patients will be invited to participate by the hospital (Academic or Community) which is going to discharge the patient.

Participating investigators will belong to hospitals (Academic, Community, with/without cathlab, etc), in the proportion representing the reality of where this kind of patients are managed in each country.

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01171404

Show 411 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Mónica Tafalla

Medical Department.AstraZeneca Spain

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01171404 History of Changes
Other Study ID Numbers:	NIS-CEU-DUM-2009/1
Study First Received:	July 27, 2010
Last Updated:	March 27, 2012
Health Authority:	Belgium: Institutional Review Board Brazil: National Committee of Ethics in Research Brazil: Ethics Committee Denmark: Danish Dataprotection Agency Finland: Ethics Committee Finland: Ministry of Social Affairs and Health France: Institutional Ethical Committee France: French Data Protection Authority Germany: Ethics Commission Greece: Ethics Committee Greece: Ministry of Health and Welfare Italy: Ethics Committee Mexico: Ethics Committee Netherlands: Independent Ethics Committee Norway: The National Committees for Research Ethics in Norway Poland: Ethics Committee Portugal: Ethics Committee for Clinical Research Romania: National Medicines Agency Romania: Ministry of Public Health Slovenia: Ethics Committee Spain: Ethics Committee Spain: Agencia Española de Medicamentos y Productos Sanitarios Turkey: Ministry of Health United Kingdom: Research Ethics Committee Venezuela: Ethics Committee

Keywords provided by AstraZeneca:

Acute coronary syndrome
heart attack
myocardial infarction
ACS long-tem follow up

antithrombotic management
quality of life
Antithrombotic

Additional relevant MeSH terms:

Angina, Unstable
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Angina Pectoris
Heart Diseases
Cardiovascular Diseases

Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on May 24, 2012