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

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ClinicalTrials.gov Identifier: NCT01212302
Recruitment Status : Completed
First Posted : September 30, 2010
Results First Posted : September 16, 2011
Last Update Posted : September 16, 2011
Sponsor:
Information provided by:
Ruhr University of Bochum

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Coronary Artery Disease
Intervention Drug: Optimizing ASA and clopidogrel treatment
Enrollment 500
Recruitment Details Medical Clinic, 504 patients 2007-2010
Pre-assignment Details post coronary stenting
Arm/Group Title Aspirin, Clopidogrel
Hide Arm/Group Description 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)
Period Title: Overall Study
Started 504
Completed 504
Not Completed 0
Arm/Group Title Aspirin, Clopidogrel
Hide Arm/Group Description 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)
Overall Number of Baseline Participants 504
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 504 participants
<=18 years
0
   0.0%
Between 18 and 65 years
294
  58.3%
>=65 years
210
  41.7%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 504 participants
64.3  (11.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 504 participants
Female
154
  30.6%
Male
350
  69.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 504 participants
504
1.Primary Outcome
Title Number of Participants Who Were Responders or Low-Responders of Antiplatelet Therapy as a Result of Whole Blood Aggregometry Testing (See Outcome Measure Description)
Hide Description

In patients treated with aspirin and clopidogrel aggregometry was performed and depending on the results the patients were either responder or low-responder of antiplatelet therapy.

The following definitions were used for clopidogrel low response (CLR: >5 ohm when stimulated with adenosine diphosphate (ADP) 5 μM) and ASA low response (ALR: >0 ohm;stimulated with arachidonic acid 10 μM) with the ChronoLog 590 aggregometer. In the case of low-response alternative antiplatelet therapy was modified according to the study plan (see protocol section).

Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Sample size calculation: With the assumption that the incidence of clopidogrel low response was at least 20% and ASA low response 10%. Choosing a power of 97.5% and a two-sided value of 0.05, an overall sample size was required of at least 400 patients. To compensate for a possible loss of follow-up, we aimed for inclusion of approx. 500 patients.
Arm/Group Title Clopidogrel Low Response
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 504
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: participants
155
(155 to 155)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aspirin, Clopidogrel
Hide Arm/Group Description 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)
All-Cause Mortality
Aspirin, Clopidogrel
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Aspirin, Clopidogrel
Affected / at Risk (%)
Total   0/504 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Aspirin, Clopidogrel
Affected / at Risk (%)
Total   0/504 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Dr Horst Neubauer
Organization: Cardiology Dep, Ruhr-University Bochum
Phone: +49-234-509-2326
EMail: Horst.Neubauer@rub.de
Publications:
Layout table for additonal information
Responsible Party: Horst Neubauer, MD, Ruhr-University Bochum
ClinicalTrials.gov Identifier: NCT01212302     History of Changes
Other Study ID Numbers: BOCLAplan01
F654R ( Registry Identifier: F654R Ruhr-University Bochum )
First Submitted: September 29, 2010
First Posted: September 30, 2010
Results First Submitted: February 28, 2011
Results First Posted: September 16, 2011
Last Update Posted: September 16, 2011