Perioperative Aspirin Response in Patients Undergoing Vascular Surgery

NCT ID: NCT03587324

Last Updated: 2018-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2015-03-31

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.

Conditions

Vascular Surgery Patient With PAD / Carotid Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Experimental: aspirin, clopidogrel

Perioperative measurement of ASA and clopidogrel resistance in patients undergoing vascular treatment

Group Type: EXPERIMENTAL

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

Intervention Type: 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)

Interventions

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

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)

Intervention Type: DRUG

Eligibility Criteria

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,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Josef Hospital Bochum

OTHER

Sponsor Role: lead

Responsible Party

Dr. Thomas Hummel

Thomas Hummel MD, head of the arterial department, vice head of the vascular department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Bochum, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

Ruhr University of Bochum

Identifier Type: -

Identifier Source: org_study_id