Outcome of Longterm Antithrombotic Therapy in Acute Coronary Syndrome Patients

NCT01623700 | Unknown

• 1 other identifier: U-11-001
• Study Type: observational
• Target: 78,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome; Myocardial Infarction

Keywords

clopidogrel; aspirin; percutaneous coronary intervention; coronary stenting; antiplatelet

Outcome Measures

Primary Outcomes (1)

• number of patients with adverse events in patient groups with different antithrombotic treatment strategies

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

  up to 5 years and 6 months

Study Arms (3)

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 Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

Sponsors & Collaborators

• Uppsala University: lead
• AstraZeneca: collaborator

Study Sites (1)

Uppsala Clinical Research Center and Department of Medical Sciences, Uppsala University

Uppsala, Uppsala County, 75237, Sweden

Location

Related Publications (1)

• Varenhorst C, Jensevik K, Jernberg T, Sundstrom A, Hasvold P, Held C, Lagerqvist B, James S. Duration of dual antiplatelet treatment with clopidogrel and aspirin in patients with acute coronary syndrome. Eur Heart J. 2014 Apr;35(15):969-78. doi: 10.1093/eurheartj/eht438. Epub 2013 Oct 11.

  PMID: 24122961 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome; Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Stefan James, MD, PhD

  Uppsala Clinical Research Center and Department of Medical Sciences, Cardiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2012
• First Posted: June 20, 2012
• Study Start: January 1, 2006
• Last Updated: June 20, 2012

Record last verified: 2011-05

Locations

SE (1)