The Antiaggregation Monitoring (TAM) Registry

NCT ID: NCT01329224

Last Updated: 2021-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-04-30

Brief Summary

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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

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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.

Conditions

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Aspirin Causing Adverse Effects in Therapeutic Use

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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TAM patients

All consecutive patients under chronic ASA treatment (100mg/d) seen at our outpatient clinic.

Measurement of platelet anti-aggregation

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stephane Cook

OTHER

Sponsor Role lead

Responsible Party

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Stephane Cook

Prof.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Stéphane Cook, Prof

Role: PRINCIPAL_INVESTIGATOR

Fribourg University

Locations

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Service de Cardiologie, Hôpital Cantonal Fribourg

Fribourg, Canton of Fribourg, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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242/10A

Identifier Type: -

Identifier Source: org_study_id