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Resistance to antiplatelet drugs (aspirin, clopidogrel) is a recognized phenomenon with a prevalence from 17% to 35%. Resistance as detected by in vitro tests such as Multiple Electrode Aggregometry (MEA) has been shown to predict clinical therapy failure. Resistance can be caused by clinical, cellular and pharmacogenetic factors. Non compliance is suspected to be an important contributing factor. In this study, compliance will be assured with an electronical compliance monitoring system. Factors to non response will be identified to find plausible explanations when in vitro platelet aggregation inhibition is insufficient despite assured compliance. This study will help to disclose the relationship between compliance, biomarker and clinical outcome as well as to quantify the impact of non compliance to the resistance phenomenon as measured by MEA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dual therapy (ASS/CLO) | patients with a prescription for dual antiplatelet therapy with aspirin AND clopidogrel | ||
| clopidogrel users (CLO) | patients with a prescription for clopidogrel | ||
| aspirin users (ASP) | patients with a prescription for aspirin |
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| Measure | Description | Time Frame |
|---|---|---|
| Platelet aggregation, initial and after one week under compliance monitoring. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Data on compliance (measured by electronic compliance monitoring, Morisky MMAS-8 and BMQ Score) | 1 week | |
| Frequency of contributing factors to non-response in responders compared to non-responders (pharmacogenetics, clinical factors and drug-drug interactions) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with a prescription for aspirin and/or clopidogrel seeing their general practitioner (GP) for any purpose
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| Name | Affiliation | Role |
|---|---|---|
| Kurt E Hersberger, PhD | Pharmaceutical Care Research Group, Departement of Pharmacy, University Basel | Study Chair |
| Michel Romanens, MD | Kardiologische Praxis, Olten/SO | Principal Investigator |
| Dimitrios Tsakiris, MD | Hemostaseology Lab, University Hospital Basel | Study Director |
| Philipp N Walter, MSc | Pharmaceutical Care Research Group, Department of Pharmacy, University of Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study Centre at Aarelab AG, Olten | Olten | Canton of Solothurn | 4600 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24175592 | Derived | Walter PN, Tsakiris DA, Romanens M, Arnet I, Hersberger KE. Antiplatelet resistance in outpatients with monitored adherence. Platelets. 2014;25(7):532-8. doi: 10.3109/09537104.2013.845743. Epub 2013 Oct 31. |
| Label | URL |
|---|---|
| Pharmaceutical Care Research Group, Departement of Pharmacy, University Basel | View source |
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| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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blood samples for routine laboratory testing and platelet aggregometry blood samples for pharmacogenetic analysis
| 4 weeks |
| D001519 | Behavior |