Aspirin and Clopidogrel Resistance Study

NCT ID: NCT01039480

Last Updated: 2012-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

82 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Drug Resistance

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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dual therapy (ASS/CLO)

patients with a prescription for dual antiplatelet therapy with aspirin AND clopidogrel

No interventions assigned to this group

clopidogrel users (CLO)

patients with a prescription for clopidogrel

No interventions assigned to this group

aspirin users (ASP)

patients with a prescription for aspirin

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Pharmaceutical Care Research Group

Principal Investigators

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Kurt E Hersberger, PhD

Role: STUDY_CHAIR

Pharmaceutical Care Research Group, Departement of Pharmacy, University Basel

Michel Romanens, MD

Role: PRINCIPAL_INVESTIGATOR

Kardiologische Praxis, Olten/SO

Dimitrios Tsakiris, MD

Role: STUDY_DIRECTOR

Hemostaseology Lab, University Hospital Basel

Philipp N Walter, MSc

Role: PRINCIPAL_INVESTIGATOR

Pharmaceutical Care Research Group, Department of Pharmacy, University of Basel

Locations

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Study Centre at Aarelab AG, Olten

Olten, Canton of Solothurn, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 24175592 (View on PubMed)

Related Links

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http://www.pharmacare.unibas.ch

Pharmaceutical Care Research Group, Departement of Pharmacy, University Basel

Other Identifiers

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PCRG_003_PW

Identifier Type: -

Identifier Source: org_study_id

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