Aspirin and Clopidogrel Resistance Study

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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Key information

Conditions

Drug Resistance Behavior Health Behavior Medication Adherence Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Study Centre at Aarelab AG, Olten

Olten, Canton of Solothurn, 4600, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Platelet aggregation, initial and after one week under compliance monitoring.

Time frame: 1 week

Secondary outcomes

Data on compliance (measured by electronic compliance monitoring, Morisky MMAS-8 and BMQ Score)

Time frame: 1 week
Frequency of contributing factors to non-response in responders compared to non-responders (pharmacogenetics, clinical factors and drug-drug interactions)

Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Aspirin- and Clopidogrel-Resistance: Non-compliance and Other Contributing Factors

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Dec 25, 2009
Registry last updated: Feb 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed