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The Antiaggregation Monitoring (TAM) Registry (TAM)

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ClinicalTrials.gov Identifier: NCT01329224
Recruitment Status : Unknown
Verified November 2010 by University Hospital Freiburg.
Recruitment status was:  Recruiting
First Posted : April 5, 2011
Last Update Posted : April 18, 2011
Sponsor:
Information provided by:
University Hospital Freiburg

Brief 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.

Condition or disease Intervention/treatment
Aspirin Causing Adverse Effects in Therapeutic Use Other: Measurement of platelet anti-aggregation

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 Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Acetylsalicylic Acid in Outpatient Practice - Results From The Antiaggregation Monitoring (TAM) Registry
Study Start Date : November 2010
Estimated Primary Completion Date : April 2011
Estimated Study Completion Date : April 2011

Group/Cohort Intervention/treatment
TAM patients
All consecutive patients under chronic ASA treatment (100mg/d) seen at our outpatient clinic.
Other: Measurement of platelet anti-aggregation
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.



Primary Outcome Measures :
  1. Whole blood impedance platelet aggregometry to assess acetylsalicylic acid resistance rates [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All consecutive patients under chronic ASA treatment seen at our outpatient clinic
Criteria

Inclusion Criteria:

  • patients under chronic ASA treatment for more then one month

Exclusion Criteria:

  • concomitant use of nonsteroidal anti-inflammatory drugs (NSAIDs)
  • thrombocytopenia
  • thrombocytosis
  • age <18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01329224


Contacts
Contact: Stéphane Cook, Prof. 0041264268140 CookS@h-fr.ch
Contact: Markus Oberhaensli, MD 0041264268141 oberm3@hotmail.com

Locations
Switzerland
Service de Cardiologie, Hôpital Cantonal Fribourg Recruiting
Fribourg, FR, Switzerland, 1708
Principal Investigator: Stéphane Cook, MD         
Sponsors and Collaborators
University Hospital Freiburg
Investigators
Principal Investigator: Stéphane Cook, Prof Fribourg University

Responsible Party: Prof. Stéphane Cook, University Freibourg
ClinicalTrials.gov Identifier: NCT01329224     History of Changes
Other Study ID Numbers: 242/10A
First Posted: April 5, 2011    Key Record Dates
Last Update Posted: April 18, 2011
Last Verified: November 2010

Keywords provided by University Hospital Freiburg:
acetylsalicylic acid resistance

Additional relevant MeSH terms:
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics