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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01623700
Other study ID # U-11-001
Secondary ID
Status Active, not recruiting
Phase N/A
First received May 29, 2012
Last updated June 15, 2012
Start date January 2006

Study information

Verified date May 2011
Source Uppsala University
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review BoardSweden: The National Board of Health and Welfare
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 78000
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
Sweden Uppsala Clinical Research Center and Department of Medical Sciences, Uppsala University Uppsala Uppsala County

Sponsors (2)

Lead Sponsor Collaborator
Uppsala University AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
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