An interventional study of Optimizing ASA and clopidogrel treatment in Coronary Artery Disease, sponsored by Ruhr University of Bochum. Completed at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-09-16.
Sponsored by Ruhr University of Bochum · Not applicable, Interventional, and Treatment
Dual antiplatelet therapy with acetylsalicylic acid (ASA, aspirin) and clopidogrel is of great importance for treatment following coronary stenting. Unfortunately the variable platelet inhibitory effectiveness compromises the antithrombotic benefit of dual antiplatelet therapy. The aim of this prospective single centre study was to reduce the low response incidence of dual antiplatelet therapy with ASA and clopidogrel based on a standardized therapy algorithm.
Platelet function testing using whole blood aggregometry was performed 48 hours following coronary stenting (either acute coronary syndromes or stable coronary artery disease). The antiplatelet therapy included a loading dose of 600 mg clopidogrel and 500 mg ASA, followed by 75 mg clopidogrel and 100 mg ASA once daily. Clopidogrel low-response (CLR) and/or ASA (ASA low response) were treated according to a structured therapy plan.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 500 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Ruhr University of Bochum is the lead sponsor of 124 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Also known as: 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)
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
Medical Clinic, 504 patients 2007-2010
| Milestone | Aspirin, Clopidogrel |
|---|---|
| Started | 504 |
| Completed | 504 |
| Not completed | 0 |
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).
| participants | Clopidogrel Low Response |
|---|---|
| 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 (155 to 155) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Aspirin, Clopidogrel | — | 0/504 (0%) | 0/504 (0%) |
| Age, Categorical(Participants) | Aspirin, Clopidogrel |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 294 |
| >=65 years | 210 |
| Age Continuous(years) | Aspirin, Clopidogrel |
|---|---|
| Mean | 64.3 ± 11.7 |
| Sex: Female, Male(Participants) | Aspirin, Clopidogrel |
|---|---|
| Female | 154 |
| Male | 350 |
| Region of Enrollment(participants) | Aspirin, Clopidogrel |
|---|---|
| Germany | 504 |
This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.
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Ruhr University of Bochum