Perioperative Aspirin Response in Patients Undergoing Vascular Surgery

Vascular Surgery Patient With PAD / Carotid Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03587324
• Other study ID #: Ruhr University of Bochum
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: March 2015

Study information

• Verified date: July 2018
• Source: St. Josef Hospital Bochum
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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,

Related Conditions & MeSH terms

• Carotid Stenosis
• Vascular Surgery Patient With PAD / Carotid Stenosis

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
Germany	Department of vascular surgery, St. Josef Hospital, Ruhr University of Bochum	Bochum	NRW

Sponsors (1)

Lead Sponsor	Collaborator
St. Josef Hospital Bochum

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years