Aspirin and Clopidogrel Resistance Study

NCT01039480 | Completed

• 1 other identifier: PCRG_003_PW
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Resistance

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  1 week

Secondary Outcomes (2)

• 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

Study Arms (3)

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

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Study Centre at Aarelab AG, Olten

Olten, Canton of Solothurn, 4600, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 24175592 DERIVED

Related Links

• Pharmaceutical Care Research Group, Departement of Pharmacy, University Basel

Biospecimen

Retention: SAMPLES WITH DNA

blood samples for routine laboratory testing and platelet aggregometry blood samples for pharmacogenetic analysis

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Kurt E Hersberger, PhD

  Pharmaceutical Care Research Group, Departement of Pharmacy, University Basel

  STUDY CHAIR

• Michel Romanens, MD

  Kardiologische Praxis, Olten/SO

  PRINCIPAL INVESTIGATOR

• Dimitrios Tsakiris, MD

  Hemostaseology Lab, University Hospital Basel

  STUDY DIRECTOR

• Philipp N Walter, MSc

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 23, 2009
• First Posted: December 25, 2009
• Study Start: May 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: October 1, 2011
• Last Updated: February 9, 2012

Record last verified: 2012-02

Locations

CH (1)