Perioperative Aspirin Response in Patients Undergoing Vascular Surgery

Not Applicable

Completed

• Conditions: Vascular Surgery Patient With PAD / Carotid Stenosis
• Interventions: Drug: Whole blood aggregometry before and after vascular treatment (ASA/ Clopidogrel).

• Registration Number: NCT03587324
• Lead Sponsor: St. Josef Hospital Bochum

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2013-02
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2018-07
• Study First Submitted: 2018-07-02
• Study First Submitted QC: 2018-07-02
• Study First Posted: 2018-07-16
• Last Update Submitted: 2018-07-16
• Last Update Posted: 2018-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: aspirin, clopidogrel	Whole blood aggregometry before and after vascular treatment (ASA/ Clopidogrel).	Perioperative measurement of ASA and clopidogrel resistance in patients undergoing vascular treatment

Primary Outcome Measures

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

Trial Locations

Locations (1)

Department of vascular surgery, St. Josef Hospital, Ruhr University of Bochum; 🇩🇪 Bochum, NRW, Germany