Perioperative Aspirin Response in Patients Undergoing Vascular Surgery

St. Josef Hospital Bochum176 enrolled

Overview

Reduced antiplatelet activity (low response (LR)/high on-treatment platelet reactivity (HPR)) of aspirin (ALR) or clopidogrel (CLR) is associated with an increased risk of thromboembolic events. The prevalence figures for low-responders reported in the literature vary widely and there have been few investigations in vascular surgery patients to date. The aim of this prospective monocentric study was to increase the evidence base on vascular surgery patients and to detect any changes in the response following vascular surgery procedures.

The activity of aspirin (acetylsalicylic acid, ASA) and clopidogrel is measured by whole blood impedance aggregometry using a multiple electrode aggregometer (Multiplate). The agonists used are arachidonic acid for aspirin and adenosine diphosphate (ADP) for clopidogrel. Vascular patients requiring treatment for peripheral artery disease (PAD) and/or carotid stenosis are included in the study. To identify possible risk factors demographic data, concomitant medication, laboratory parameters, co-morbidities, severity of the condition and the type of procedure performed are documented. In addition, a follow-up aggregometry is performed after completion of the vascular procedure.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

176

Conditions

Vascular Surgery Patient With PAD / Carotid Stenosis

Interventions

Whole blood aggregometry before and after vascular treatment (ASA/ Clopidogrel).DRUG

To identify possible risk factors demographic data, concomitant medication, laboratory parameters, co-morbidities, severity of the condition and the type of procedure performed are documented. Other Name: ASA (aspirin), Clopidogrel (Plavix)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: • Vascular patients requiring treatment for peripheral artery disease (PAD) and/or carotid stenosis are included in the study. Exclusion Criteria: * non-adherence to the antiplatelet medication * abnormal platelet count in patients, * current gastrointestinal disorders, * current infections, * serious concomitant medical conditions (such as recent gastrointestinal bleeding, cancer, severe cardiac or liver disorders) * known bleeding or coagulation disorders,

Locations (1)

Department of vascular surgery, St. Josef Hospital, Ruhr University of Bochum

Bochum, North Rhine-Westphalia, Germany

Outcomes

Primary Outcomes

Number of Participants Who Were Responders or Low-Responders of Antiplatelet Therapy as a Result of Whole Blood Aggregometry Testing

In patients treated with aspirin and clopidogrel aggregometry was performed and depending on the results the patients were either responder or low-responder of antiplatelet therapy.

Time frame: 2 years

Data from ClinicalTrials.gov

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