Outcome of Longterm Antithrombotic Therapy in Acute Coronary Syndrome Patients

Sponsor
Uppsala University (Other)
Overall Status
Unknown status
CT.gov ID
NCT01623700
Collaborator
AstraZeneca (Industry)
78,000
1

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    78000 participants
    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
    Study Start Date :
    Jan 1, 2006

    Arms and Interventions

    Arm Intervention/Treatment
    dual antiplatelet treatment 12 months after ACS event

    dual antiplatelet treatment 6 months after ACS event

    dual antiplatelet treatment 3 months after ACS event

    Outcome Measures

    Primary Outcome Measures

    1. number of patients with adverse events in patient groups with different antithrombotic treatment strategies [up to 5 years and 6 months]

      adverse events such as: mortality, re-infarction, revascularization, ischemic- and non-ischemic stroke and bleeding

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Uppsala University
    ClinicalTrials.gov Identifier:
    NCT01623700
    Other Study ID Numbers:
    • U-11-001
    First Posted:
    Jun 20, 2012
    Last Update Posted:
    Jun 20, 2012
    Last Verified:
    May 1, 2011

    Study Results

    No Results Posted as of Jun 20, 2012