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Aspirin and Clopidogrel Resistance Study

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ClinicalTrials.gov Identifier: NCT01039480
Recruitment Status : Completed
First Posted : December 25, 2009
Last Update Posted : February 9, 2012
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease
Drug Resistance

Study Design

Study Type : Observational
Actual Enrollment : 82 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Aspirin- and Clopidogrel-Resistance: Non-compliance and Other Contributing Factors
Study Start Date : May 2010
Primary Completion Date : June 2011
Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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


Outcome Measures

Primary Outcome Measures :
  1. Platelet aggregation, initial and after one week under compliance monitoring. [ Time Frame: 1 week ]

Secondary Outcome Measures :
  1. Data on compliance (measured by electronic compliance monitoring, Morisky MMAS-8 and BMQ Score) [ Time Frame: 1 week ]
  2. Frequency of contributing factors to non-response in responders compared to non-responders (pharmacogenetics, clinical factors and drug-drug interactions) [ Time Frame: 4 weeks ]

Biospecimen Retention:   Samples With DNA
blood samples for routine laboratory testing and platelet aggregometry blood samples for pharmacogenetic analysis

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with a prescription for aspirin and/or clopidogrel seeing their general practitioner (GP) for any purpose
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01039480


Locations
Switzerland
Study Centre at Aarelab AG, Olten
Olten, Solothurn, Switzerland, 4600
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Philipp N. Walter, Investigator, Pharmaceutical Care Research Group
ClinicalTrials.gov Identifier: NCT01039480     History of Changes
Other Study ID Numbers: PCRG_003_PW
First Posted: December 25, 2009    Key Record Dates
Last Update Posted: February 9, 2012
Last Verified: February 2012

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
Ticlopidine
Clopidogrel
Platelet Aggregation Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors