Aspirin and Clopidogrel Resistance Study

February 8, 2012 updated by: University Hospital, Basel, Switzerland

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

82

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Solothurn
      • Olten, Solothurn, Switzerland, 4600
        • Study Centre at Aarelab AG, Olten

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with a prescription for aspirin and/or clopidogrel seeing their general practitioner (GP) for any purpose

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Platelet aggregation, initial and after one week under compliance monitoring.
Time Frame: 1 week
1 week

Secondary Outcome Measures

Outcome Measure
Time Frame
Data on compliance (measured by electronic compliance monitoring, Morisky MMAS-8 and BMQ Score)
Time Frame: 1 week
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
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

December 23, 2009

First Submitted That Met QC Criteria

December 24, 2009

First Posted (Estimate)

December 25, 2009

Study Record Updates

Last Update Posted (Estimate)

February 9, 2012

Last Update Submitted That Met QC Criteria

February 8, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PCRG_003_PW

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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