Optimizing Aspirin and Clopidogrel Therapy (BOchum CLopidogrel and Aspirin Plan) (BOCLAplan)

This study has been completed.
Sponsor:
Information provided by:
Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT01212302
First received: September 29, 2010
Last updated: August 11, 2011
Last verified: September 2010
Results First Received: February 28, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Coronary Artery Disease
Intervention: Drug: Optimizing ASA and clopidogrel treatment

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Medical Clinic, 504 patients 2007-2010

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
post coronary stenting

Reporting Groups
  Description
Aspirin, Clopidogrel If the treatment with aspirin and/or clopidogrel is insufficient (platelet function testing) the dose was increased or the drug was changed (clopidogrel to ticlopidine or prasugrel)

Participant Flow:   Overall Study
    Aspirin, Clopidogrel  
STARTED     504  
COMPLETED     504  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Aspirin, Clopidogrel If the treatment with aspirin and/or clopidogrel is insufficient (platelet function testing) the dose was increased or the drug was changed (clopidogrel to ticlopidine or prasugrel)

Baseline Measures
    Aspirin, Clopidogrel  
Number of Participants  
[units: participants]
  504  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     294  
>=65 years     210  
Age  
[units: years]
Mean ± Standard Deviation
  64.3  ± 11.7  
Gender  
[units: participants]
 
Female     154  
Male     350  
Region of Enrollment  
[units: participants]
 
Germany     504  



  Outcome Measures

1.  Primary:   Number of Participants Who Were Responders or Low-Responders of Antiplatelet Therapy as a Result of Whole Blood Aggregometry Testing (See Outcome Measure Description)   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr Horst Neubauer
Organization: Cardiology Dep, Ruhr-University Bochum
phone: +49-234-509-2326
e-mail: Horst.Neubauer@rub.de


Publications:

Publications automatically indexed to this study:

Responsible Party: Horst Neubauer, MD, Ruhr-University Bochum
ClinicalTrials.gov Identifier: NCT01212302     History of Changes
Other Study ID Numbers: BOCLAplan01, F654R
Study First Received: September 29, 2010
Results First Received: February 28, 2011
Last Updated: August 11, 2011
Health Authority: Germany: Ethics Commission