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Outcome of Longterm Antithrombotic Therapy in Acute Coronary Syndrome Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2011 by Uppsala University.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01623700
First Posted: June 20, 2012
Last Update Posted: June 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Uppsala University
  Purpose

This observational study will based on the Register of Information and Knowledge About Swedish Heart Intensive Care Admissions (RIKS-HIA) and the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) which since 2009 are merged into The Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART).

The aim of this study is to investigate the impact of different antithrombotic treatment options (treatment duration, type of treatment and combination of treatments) in Acute Coronary Syndrome (ACS) patients on outcomes such as recurrent ischemic events and mortality.


Condition
Acute Coronary Syndrome Myocardial Infarction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Epidemiological Study to Investigate Outcome and Mortality With Longterm Antithrombotic Therapy in Acute Coronary Syndrome Patients

Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • number of patients with adverse events in patient groups with different antithrombotic treatment strategies [ Time Frame: up to 5 years and 6 months ]
    adverse events such as: mortality, re-infarction, revascularization, ischemic- and non-ischemic stroke and bleeding


Enrollment: 78000
Study Start Date: January 2006
Groups/Cohorts
dual antiplatelet treatment 12 months after ACS event
dual antiplatelet treatment 6 months after ACS event
dual antiplatelet treatment 3 months after ACS event

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients previously enrolled into the SWEDEHEART (RIKS-HIA/SCAAR/SEPHIA) registry from 1 Jan 2006 to 1 July 2010 with an event of ACS and observed during the index hospitalization following enrollment.
Criteria

Inclusion Criteria:

  • Patient with an event of ACS under the study period
  • Patient found in the National Registry of Drug Prescriptions and treated or not treated with antithrombotic drug/s (acetylsalicylic acid and/or either clopidogrel/ticlopidine/prasugrel and/or warfarin)

Exclusion Criteria:

  • Patients will not be excluded from the database if they fulfill inclusion criteria.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01623700


Locations
Sweden
Uppsala Clinical Research Center and Department of Medical Sciences, Uppsala University
Uppsala, Uppsala County, Sweden, 75237
Sponsors and Collaborators
Uppsala University
AstraZeneca
Investigators
Principal Investigator: Stefan James, MD, PhD Uppsala Clinical Research Center and Department of Medical Sciences, Cardiology
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT01623700     History of Changes
Other Study ID Numbers: U-11-001
First Submitted: May 29, 2012
First Posted: June 20, 2012
Last Update Posted: June 20, 2012
Last Verified: May 2011

Keywords provided by Uppsala University:
clopidogrel
aspirin
percutaneous coronary intervention
coronary stenting
antiplatelet

Additional relevant MeSH terms:
Syndrome
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Disease
Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases