Outcome of Longterm Antithrombotic Therapy in Acute Coronary Syndrome Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Uppsala University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Uppsala University
ClinicalTrials.gov Identifier:
NCT01623700
First received: May 29, 2012
Last updated: June 15, 2012
Last verified: May 2011
  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 ] [ Designated as safety issue: No ]
    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

Genders Eligible for Study:   Both
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
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: 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

No publications provided by Uppsala University

Additional 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
Study First Received: May 29, 2012
Last Updated: June 15, 2012
Health Authority: Sweden: Regional Ethical Review Board
Sweden: The National Board of Health and Welfare

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

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

ClinicalTrials.gov processed this record on October 23, 2014