Perioperative Aspirin Response in Patients Undergoing Vascular Surgery

NCT03587324 | Completed

• 1 other identifier: Ruhr University of Bochum
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Surgery Patient With PAD / Carotid Stenosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Experimental: aspirin, clopidogrel

EXPERIMENTAL

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

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

Interventions

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)

Experimental: aspirin, clopidogrel

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Vascular patients requiring treatment for peripheral artery disease (PAD) and/or carotid stenosis are included in the study.

You may not qualify if:

• 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,

Sponsors & Collaborators

• St. Josef Hospital Bochum: lead

Study Sites (1)

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

Bochum, North Rhine-Westphalia, 44791, Germany

Location

MeSH Terms

Conditions

Carotid Stenosis

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Thomas Hummel MD, head of the arterial department, vice head of the vascular department

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: July 16, 2018
• Study Start: February 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: July 18, 2018

Record last verified: 2018-07

Locations

DE (1)