Trial Outcomes & Findings for Optimizing Aspirin and Clopidogrel Therapy (BOchum CLopidogrel and Aspirin Plan) (NCT NCT01212302)
NCT ID: NCT01212302
Last Updated: 2011-09-16
Results Overview
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).
COMPLETED
NA
500 participants
2 years
2011-09-16
Participant Flow
Medical Clinic, 504 patients 2007-2010
post coronary stenting
Participant milestones
| Measure |
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)
|
|---|---|
|
Overall Study
STARTED
|
504
|
|
Overall Study
COMPLETED
|
504
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optimizing Aspirin and Clopidogrel Therapy (BOchum CLopidogrel and Aspirin Plan)
Baseline characteristics by cohort
| Measure |
Aspirin, Clopidogrel
n=504 Participants
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)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
294 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
210 Participants
n=99 Participants
|
|
Age Continuous
|
64.3 years
STANDARD_DEVIATION 11.7 • n=99 Participants
|
|
Sex: Female, Male
Female
|
154 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
350 Participants
n=99 Participants
|
|
Region of Enrollment
Germany
|
504 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: 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.
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).
Outcome measures
| Measure |
Clopidogrel Low Response
n=504 Participants
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)
|
|---|---|
|
Number of Participants Who Were Responders or Low-Responders of Antiplatelet Therapy as a Result of Whole Blood Aggregometry Testing (See Outcome Measure Description)
|
155 participants
Interval 155.0 to 155.0
|
Adverse Events
Aspirin, Clopidogrel
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Horst Neubauer
Cardiology Dep, Ruhr-University Bochum
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place