Aspirin Causing Adverse Effects in Therapeutic UseTAMNCT01329224
The Antiaggregation Monitoring (TAM) Registry
An observational study of Aspirin Causing Adverse Effects in Therapeutic Use, run by Stephane Cook at 1 site in Switzerland.
Trial summary
The purpose of this study is to investigate the incidence of acetylsalicylic acid resistance (ASA-R) among patients under chronic acetylsalicylic acid(ASA) treatment seen at our outpatient clinic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aspirin Causing Adverse Effects in Therapeutic Use
- What is being tested?
- Measurement of platelet anti-aggregation
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2010to Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients under chronic ASA treatment seen at our outpatient clinic
Who may be able to join
- patients under chronic ASA treatment for more then one month
Who cannot join
- concomitant use of nonsteroidal anti-inflammatory drugs (NSAIDs)
- thrombocytopenia
- thrombocytosis
- age <18 years
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Service de Cardiologie, Hôpital Cantonal Fribourg
Fribourg, Canton of Fribourg, 1708
About this study
Official title: Acetylsalicylic Acid in Outpatient Practice - Results From The Antiaggregation Monitoring (TAM) Registry
The purpose of this study is to investigate the incidence of acetylsalicylic acid resistance (ASA-R) among patients under chronic acetylsalicylic acid(ASA) treatment seen at our outpatient clinic.
Read the detailed description
Acetylsalicylic acid (ASA) resistance (R) is best defined as an ineffective inhibition of the platelet cyclooxygenase (COX)-1 pathway, and has been reported in 1 to 61 % of patients treated with ASA. Impaired response to ASA has been associated with an increased risk of ischemic events in patients with known coronary artery disease. We sought to investigate the incidence of ASA-R in clinical practice.
All consecutive patients under chronic ASA treatment (100mg/d) seen at our outpatient clinic were systematically included in the registry. All patients were on acetylsalicylic acid for CAD for at least 1 month. Patients were informed of ASA testing at start of consultation in the outpatient clinic. Eligible patients provided written informed consent. Peripheral venous blood samples were analyzed using the whole blood impedance platelet aggregometry Multiplate analyzer. The Multiplate analyzer device allows to measure platelet aggregation by the attachment of platelets to two silver coated copper electrodes leading to a rise of electrical resistance in the sample. The measurements are expressed as arbitrary aggregation units (AU) and the manufacturers defined cutoffs were used: normal values were 76-136 AU, partial antiaggregation was defined as ASA values between 31 and 75 AU and complete antiaggregation was defined as ASA values < 31 AU.
- Being tested
- Measurement of platelet anti-aggregation
- Keywords
- acetylsalicylic acid resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of platelet anti-aggregationOther
Whole blood impedance platelet aggregometry was performed with the Multiplate analyzer (Dynabyte, Munich, Germany) to test the response to ASA with arachidonic acid as the trigger.
| Study group | Role | What they receive |
|---|---|---|
| TAM patients | All consecutive patients under chronic ASA treatment (100mg/d) seen at our outpatient clinic. Receives: Other: Measurement of platelet anti-aggregation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole blood impedance platelet aggregometry to assess acetylsalicylic acid resistance rates
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2011 (estimated)
- Study startNov 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aspirin Causing Adverse Effects in Therapeutic UseStudies 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stephane Cook
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stephane Cook, University Hospital Freiburg
- Investigators
- Stéphane Cook, Prof, Principal investigator, Fribourg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01329224
- Sponsor's protocol ID
- 242/10A
- Acronym
- TAM
- Status last verified
- Nov 2010
- First submitted
- 30 Mar 2011
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acetylsalicylic Acid in Outpatient Practice - Results From The Antiaggregation Monitoring (TAM) Registry
- ClinicalTrials.gov ID
- NCT01329224
- Acronym / sponsor ID
- TAM / 242/10A
- Keywords
- acetylsalicylic acid resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Stephane CookUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 5 Apr 2011 (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.
The purpose of this study is to investigate the incidence of acetylsalicylic acid resistance (ASA-R) among patients under chronic acetylsalicylic acid(ASA) treatment seen at our outpatient clinic.
Detailed description
Acetylsalicylic acid (ASA) resistance (R) is best defined as an ineffective inhibition of the platelet cyclooxygenase (COX)-1 pathway, and has been reported in 1 to 61 % of patients treated with ASA. Impaired response to ASA has been associated with an increased risk of ischemic events in patients with known coronary artery disease. We sought to investigate the incidence of ASA-R in clinical practice.
All consecutive patients under chronic ASA treatment (100mg/d) seen at our outpatient clinic were systematically included in the registry. All patients were on acetylsalicylic acid for CAD for at least 1 month. Patients were informed of ASA testing at start of consultation in the outpatient clinic. Eligible patients provided written informed consent. Peripheral venous blood samples were analyzed using the whole blood impedance platelet aggregometry Multiplate analyzer. The Multiplate analyzer device allows to measure platelet aggregation by the attachment of platelets to two silver coated copper electrodes leading to a rise of electrical resistance in the sample. The measurements are expressed as arbitrary aggregation units (AU) and the manufacturers defined cutoffs were used: normal values were 76-136 AU, partial antiaggregation was defined as ASA values between 31 and 75 AU and complete antiaggregation was defined as ASA values < 31 AU.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAM patients | – | Other: Measurement of platelet anti-aggregationAll consecutive patients under chronic ASA treatment (100mg/d) seen at our outpatient clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients under chronic ASA treatment seen at our outpatient clinic
Key inclusion criteria (1 listed)
- patients under chronic ASA treatment for more then one month
Key exclusion criteria (4 listed)
- concomitant use of nonsteroidal anti-inflammatory drugs (NSAIDs)
- thrombocytopenia
- thrombocytosis
- age <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of platelet anti-aggregationWhole blood impedance platelet aggregometry was performed with the Multiplate analyzer (Dynabyte, Munich, Germany) to test the response to ASA with arachidonic acid as the trigger. | Other | TAM patients |
Primary outcome
Whole blood impedance platelet aggregometry to assess acetylsalicylic acid resistance rates
Time frame: 6 months
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 22 Oct 2021.
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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.
Stéphane Cook, Prof principal investigator
Fribourg University
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 Aspirin Causing Adverse Effects in Therapeutic Use, run by Stephane Cook 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 1 inclusion and 4 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 22 Oct 2021. 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?
Whole blood impedance platelet aggregometry to assess acetylsalicylic acid resistance rates (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2021.