Aspirin and Clopidogrel Resistance Study
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Purpose
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.
| Condition |
|---|
|
Drug Resistance |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Cross-Sectional |
| Official Title: | Aspirin- and Clopidogrel-Resistance: Non-compliance and Other Contributing Factors |
- Platelet aggregation, initial and after one week under compliance monitoring. [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
- Data on compliance (measured by electronic compliance monitoring, Morisky MMAS-8 and BMQ Score) [ Time Frame: 1 week ] [ Designated as safety issue: No ]
- Frequency of contributing factors to non-response in responders compared to non-responders (pharmacogenetics, clinical factors and drug-drug interactions) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
blood samples for routine laboratory testing and platelet aggregometry blood samples for pharmacogenetic analysis
| Enrollment: | 82 |
| Study Start Date: | May 2010 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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
|
Eligibility| Ages Eligible for Study: | 45 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Patients with a prescription for aspirin and/or clopidogrel seeing their general practitioner (GP) for any purpose
Inclusion Criteria:
- Patients prescribed aspirin and/or clopidogrel for both including both cardiovascular and cerebrovascular indications seeing their general practitioner in or nearby Olten/SO for any medical purpose
- Patients with oral and written German language ability
Exclusion Criteria:
- Patients living in care homes
- Patients not preparing their drugs on their own (e.g. outpatient medical assistance through "spitex").
- Patients with acute cardiac symptoms
Contacts and Locations| Switzerland | |
| Study Centre at Aarelab AG, Olten | |
| Olten, Solothurn, Switzerland, 4600 | |
| Study Chair: | Kurt E Hersberger, PhD | Pharmaceutical Care Research Group, Departement of Pharmacy, University Basel |
| Principal Investigator: | Michel Romanens, MD | Kardiologische Praxis, Olten/SO |
| Study Director: | Dimitrios Tsakiris, MD | Hemostaseology Lab, University Hospital Basel |
| Principal Investigator: | Philipp N Walter, MSc | Pharmaceutical Care Research Group, Department of Pharmacy, University of Basel |
More Information
Additional Information:
No publications provided
| Responsible Party: | Philipp N. Walter, Investigator, Pharmaceutical Care Research Group |
| ClinicalTrials.gov Identifier: | NCT01039480 History of Changes |
| Other Study ID Numbers: | PCRG_003_PW |
| Study First Received: | December 23, 2009 |
| Last Updated: | February 8, 2012 |
| Health Authority: | Switzerland: Ethikkommission |
Keywords provided by University Hospital, Basel, Switzerland:
|
pharmacological biomarker compliance monitoring platelet aggregometry |
resistance Platelet Aggregation Inhibitors Medication Non-Compliance |
Additional relevant MeSH terms:
|
Aspirin Clopidogrel Platelet Aggregation Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents |
Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Central Nervous System Agents Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents |
ClinicalTrials.gov processed this record on May 23, 2013