Aspirin and Clopidogrel Resistance Study

Drug Resistance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01039480
• Other study ID #: PCRG_003_PW
• Status: Completed
• Phase: N/A
• First received: December 23, 2009
• Last updated: February 8, 2012
• Start date: May 2010
• Est. completion date: October 2011

Study information

• Verified date: February 2012
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: October 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Drug Resistance

Locations

Country	Name	City	State
Switzerland	Study Centre at Aarelab AG, Olten	Olten	Solothurn

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet aggregation, initial and after one week under compliance monitoring.		1 week	Yes
Secondary	Data on compliance (measured by electronic compliance monitoring, Morisky MMAS-8 and BMQ Score)		1 week	No
Secondary	Frequency of contributing factors to non-response in responders compared to non-responders (pharmacogenetics, clinical factors and drug-drug interactions)		4 weeks	No

External Links

•   Clinical Laboratory and Study Center, Industriestr. 78, CH-4600 Olten, Switzerland
•   Pharmaceutical Care Research Group, Departement of Pharmacy, University Basel