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Trial record 48 of 606 for:    ASPIRIN AND clopidogrel

Perioperative Aspirin Response in Patients Undergoing Vascular Surgery

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ClinicalTrials.gov Identifier: NCT03587324
Recruitment Status : Completed
First Posted : July 16, 2018
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Thomas Hummel, 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.

Condition or disease Intervention/treatment Phase
Vascular Surgery Patient With PAD / Carotid Stenosis Drug: Whole blood aggregometry before and after vascular treatment (ASA/ Clopidogrel). Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Perioperative Risk Factors for the Development of Aspirin Low Response in Patients Undergoing Vascular Surgery.
Actual Study Start Date : February 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental: aspirin, clopidogrel
Perioperative measurement of ASA and clopidogrel resistance in patients undergoing vascular treatment
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)





Primary Outcome Measures :
  1. Number of Participants Who Were Responders or Low-Responders of Antiplatelet Therapy as a Result of Whole Blood Aggregometry Testing [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03587324


Locations
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Germany
Department of vascular surgery, St. Josef Hospital, Ruhr University of Bochum
Bochum, NRW, Germany, 44791
Sponsors and Collaborators
St. Josef Hospital Bochum

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Responsible Party: Dr. Thomas Hummel, Thomas Hummel MD, head of the arterial department, vice head of the vascular department, St. Josef Hospital Bochum
ClinicalTrials.gov Identifier: NCT03587324     History of Changes
Other Study ID Numbers: Ruhr University of Bochum
First Posted: July 16, 2018    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
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Aspirin
Clopidogrel
Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents