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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Horst Neubauer, Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT01796691
First received: February 17, 2013
Last updated: February 24, 2013
Last verified: February 2013

February 17, 2013
February 24, 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) ] [ Designated as safety issue: No ]
MACE-rate
Same as current
Complete list of historical versions of study NCT01796691 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Not Provided
Not Provided
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01796691
BOCLAplan02, [Ruhr-University Bochum]
No
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP