Optimizing Aspirin and Clopidogrel Therapy (BOchum CLopidogrel and Aspirin Plan) (BOCLAplan)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Optimizing Therapy With Aspirin and Clopidogrel. The BOchum CLopidogrel and Aspirin Plan to Improve Dual Antiplatelet Therapy.|
- 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 ] [ Designated as safety issue: Yes ]
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).
|Study Start Date:||October 2008|
|Study Completion Date:||April 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
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)
Please refer to this study by its ClinicalTrials.gov identifier: 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|