Perioperative Aspirin Response in Patients Undergoing Vascular Surgery

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.

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Key information

Conditions

Vascular Surgery Patient With PAD / Carotid Stenosis Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Carotid Stenosis Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Bochum, North Rhine-Westphalia, 44791, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

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)

Primary outcomes

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

Time frame: 2 years

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.

Sponsors and collaborators

Lead sponsor

St. Josef Hospital Bochum

Other

Registry information

Official study title

Perioperative Risk Factors for the Development of Aspirin Low Response in Patients Undergoing Vascular Surgery.

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Jul 16, 2018
Registry last updated: Jul 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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