Perioperative Aspirin Response in Patients Undergoing Vascular Surgery
Primary Purpose
Vascular Surgery Patient With PAD / Carotid Stenosis
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Whole blood aggregometry before and after vascular treatment (ASA/ Clopidogrel).
Sponsored by
About this trial
This is an interventional prevention trial for Vascular Surgery Patient With PAD / Carotid Stenosis
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,
Sites / Locations
- Department of vascular surgery, St. Josef Hospital, Ruhr University of Bochum
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental: aspirin, clopidogrel
Arm Description
Perioperative measurement of ASA and clopidogrel resistance in patients undergoing vascular treatment
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03587324
Brief Title
Perioperative Aspirin Response in Patients Undergoing Vascular Surgery
Official Title
Perioperative Risk Factors for the Development of Aspirin Low Response in Patients Undergoing Vascular Surgery.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
February 2013 (Actual)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Josef Hospital Bochum
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Surgery Patient With PAD / Carotid Stenosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
176 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental: aspirin, clopidogrel
Arm Type
Experimental
Arm Description
Perioperative measurement of ASA and clopidogrel resistance in patients undergoing vascular treatment
Intervention Type
Drug
Intervention Name(s)
Whole blood aggregometry before and after vascular treatment (ASA/ Clopidogrel).
Intervention Description
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 Outcome Measure Information:
Title
Number of Participants Who Were Responders or Low-Responders of Antiplatelet Therapy as a Result of Whole Blood Aggregometry Testing
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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,
Facility Information:
Facility Name
Department of vascular surgery, St. Josef Hospital, Ruhr University of Bochum
City
Bochum
State/Province
NRW
ZIP/Postal Code
44791
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Perioperative Aspirin Response in Patients Undergoing Vascular Surgery
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