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The Bochum Optimizing Clopidogrel-Aspirin Therapy and MORTality Study (BOCLA-Mort) (BOCLA-Mort)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01796691
First Posted: February 22, 2013
Last Update Posted: February 26, 2013
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.
Information provided by (Responsible Party):
Horst Neubauer, Ruhr University of Bochum
February 17, 2013
February 22, 2013
February 26, 2013
January 2009
February 2013   (Final data collection date for primary outcome measure)
Adverse cardiac events (MACE: mortality,rehospitalisation,myocardial infarction) [ Time Frame: Follow up for up to 12 months (retrospective analysis) ]
MACE-rate
Same as current
Complete list of historical versions of study NCT01796691 on ClinicalTrials.gov Archive Site
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The Bochum Optimizing Clopidogrel-Aspirin Therapy and MORTality Study (BOCLA-Mort)
Optimized Antiplatelet Therapy With Aspirin and Clopidogrel Improves Mortality Compared to Standard Treatment.
Comparing standard treatment versus optimized antiplatelet therapy and outcomes measures.
The study is aimed to evaluate if optimized antiplatelet treatment using a test and treat algorithm (with whole blood aggregometry) is able to improve clinical outcome of patients compared to standard treatment without platelet function testing.
Observational
Observational Model: Case Control
Time Perspective: Retrospective
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Probability Sample
Patients following coronary stenting if informed consent was obtained
Coronary Artery Disease
Not Provided
  • Standard therapy
    Antiplatelet therapy following coronary stenting without platelet function testing
  • Optimized antiplatelet therapy

    Platelet function testing and according to a test and treat strategy improve the antiplatelet therapy in low-responder.

    Treatment adjustments were done as published before - see BOCLA-Plan manuscript. (Reference: Tailored antiplatelet therapy can overcome clopidogrel and aspirin resistance--the BOchum CLopidogrel and Aspirin Plan (BOCLA-Plan) to improve antiplatelet therapy. BMC Med. 2011 Jan 12;9:3.)


*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
February 2013
February 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • coronary stent implantation

Exclusion Criteria:

  • no consent
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01796691
BOCLAplan02
[Ruhr-University Bochum] ( Registry Identifier: F654R )
No
Not Provided
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Horst Neubauer, Ruhr University of Bochum
Ruhr University of Bochum
Not Provided
Principal Investigator: Horst Neubauer, MD Ruhr-University Bochum, Cardiovascular Center
Ruhr University of Bochum
February 2013