Aspirin and Clopidogrel Resistance Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01039480

Enrollment

Registered

2009-12-25

Start date

2010-05-31

Completion date

2011-10-31

Last updated

2012-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Resistance

Keywords

pharmacological biomarker, compliance monitoring, platelet aggregometry, resistance, Platelet Aggregation Inhibitors, Medication Non-Compliance

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Platelet aggregation, initial and after one week under compliance monitoring.	1 week

Secondary

Measure	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)	4 weeks

Countries

Switzerland

Outcome results