Drug ResistanceNCT01039480
Aspirin and Clopidogrel Resistance Study
An observational study of Drug Resistance, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Drug Resistance
- How many people
- 82 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2010to Oct 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a prescription for aspirin and/or clopidogrel seeing their general practitioner (GP) for any purpose
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Study Centre at Aarelab AG, Olten
Olten, Canton of Solothurn, 4600
About this study
Official title: 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.
- Conditions
- Drug Resistance
- Keywords
- pharmacological biomarker, compliance monitoring, platelet aggregometry, resistance, Platelet Aggregation Inhibitors, Medication Non-Compliance
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Platelet aggregation, initial and after one week under compliance monitoring.
Measured: 1 week
Secondary outcomes (2)
Data on compliance (measured by electronic compliance monitoring, Morisky MMAS-8 and BMQ Score)
Measured: 1 week
Frequency of contributing factors to non-response in responders compared to non-responders (pharmacogenetics, clinical factors and drug-drug interactions)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2009 (estimated)
- Study startMay 2010
- Primary completionJun 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Investigators
- Kurt E Hersberger, PhD, Study chair, Pharmaceutical Care Research Group, Departement of Pharmacy, University BaselMichel Romanens, MD, Principal investigator, Kardiologische Praxis, Olten/SODimitrios Tsakiris, MD, Study director, Hemostaseology Lab, University Hospital BaselPhilipp N Walter, MSc, Principal investigator, Pharmaceutical Care Research Group, Department of Pharmacy, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01039480
- Sponsor's protocol ID
- PCRG_003_PW
- Status last verified
- Feb 2012
- First submitted
- 23 Dec 2009
- Last updated
- 9 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24175592
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspirin- and Clopidogrel-Resistance: Non-compliance and Other Contributing Factors
- ClinicalTrials.gov ID
- NCT01039480
- Acronym / sponsor ID
- PCRG_003_PW
- Conditions
- Drug Resistance
- Keywords
- pharmacological biomarker, compliance monitoring, platelet aggregometry, resistance, Platelet Aggregation Inhibitors, Medication Non-Compliance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 25 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a prescription for aspirin and/or clopidogrel seeing their general practitioner (GP) for any purpose
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Platelet aggregation, initial and after one week under compliance monitoring.
Time frame: 1 week
2 secondary outcomes
Data on compliance (measured by electronic compliance monitoring, Morisky MMAS-8 and BMQ Score)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2012.
- Derived from this study: PubMed 24175592Walter 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.
- Pharmaceutical Care Research Group, Departement of Pharmacy, University BaselLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kurt E Hersberger, PhD study chair
Pharmaceutical Care Research Group, Departement of Pharmacy, University Basel
Michel Romanens, MD principal investigator
Kardiologische Praxis, Olten/SO
Dimitrios Tsakiris, MD study director
Hemostaseology Lab, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Resistance, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet aggregation, initial and after one week under compliance monitoring. (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01039480, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2012.