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
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Drug: Optimizing ASA and clopidogrel treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Optimizing Therapy With Aspirin and Clopidogrel. The BOchum CLopidogrel and Aspirin Plan to Improve Dual Antiplatelet Therapy.|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||April 2010|
Experimental: 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)
Drug: Optimizing ASA and clopidogrel treatment
ASA 100 mg, ASA 300 mg, ASA 500 mg
Clopidogrel 75 mg, Clopidogrel 150 mg, Ticlopidine 2x 250 mg, Prasugrel 10 mg. Intervention List:
In the case of clopidogrel low-response, the maintenance dose was doubled (repeated loading dose followed by 150 mg daily), and when still ineffective ticlopidine or prasugrel, if available and not contraindicated, were used. ASA low-responders were treated by increasing the dose to 300 mg in a first step or to 500 mg ASA when the first modification was not sufficient.
Other Name: ASA (aspirin), Clopidogrel (Plavix)
- 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 ]
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01212302
|Cardiovascular Center, Ruhr University Bochum, St. Josef - Hospital, Gudrunstrasse 56|
|Bochum, NRW, Germany, D-44791|
|Principal Investigator:||Horst Neubauer, MD||Ruhr-University Bochum, Cardiovascular Center|