Vascular Surgery Patient With PAD / Carotid StenosisNCT03587324
Perioperative Aspirin Response in Patients Undergoing Vascular Surgery
A study testing Whole blood aggregometry before and after vascular treatment (ASA/ Clopidogrel). in people with Vascular Surgery Patient With PAD / Carotid Stenosis, run by St. Josef Hospital Bochum at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Vascular Surgery Patient With PAD / Carotid Stenosis
- What is being tested?
- Whole blood aggregometry before and after vascular treatment (ASA/ Clopidogrel).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2013to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Vascular patients requiring treatment for peripheral artery disease (PAD) and/or carotid stenosis are included in the study.
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of vascular surgery, St. Josef Hospital, Ruhr University of Bochum
Bochum, North Rhine-Westphalia, 44791
About this study
Official title: Perioperative Risk Factors for the Development of Aspirin Low Response in Patients Undergoing Vascular Surgery.
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.
Read the 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.
- Being tested
- Whole blood aggregometry before and after vascular treatment (ASA/ Clopidogrel).
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| Experimental: aspirin, clopidogrel | Experimental | Perioperative measurement of ASA and clopidogrel resistance in patients undergoing vascular treatment Receives: Drug: Whole blood aggregometry before and after vascular treatment (ASA/ Clopidogrel). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study startFeb 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Surgery Patient With PAD / Carotid StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Josef Hospital Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Thomas Hummel, St. Josef Hospital Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03587324
- Sponsor's protocol ID
- Ruhr University of Bochum
- Status last verified
- Jul 2018
- First submitted
- 2 Jul 2018
- Last updated
- 18 Jul 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Risk Factors for the Development of Aspirin Low Response in Patients Undergoing Vascular Surgery.
- ClinicalTrials.gov ID
- NCT03587324
- Acronym / sponsor ID
- Ruhr University of Bochum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- St. Josef Hospital BochumUniversity, hospital or other
- Study start
- Feb 2013 (actual)
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 16 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: aspirin, clopidogrel | Experimental | Drug: Whole blood aggregometry before and after vascular treatment (ASA/ Clopidogrel).Perioperative measurement of ASA and clopidogrel resistance in patients undergoing vascular treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Vascular patients requiring treatment for peripheral artery disease (PAD) and/or carotid stenosis are included in the study.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Drug | Experimental: aspirin, clopidogrel |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole blood aggregometry before and after vascular treatment (ASA/ Clopidogrel). in people with Vascular Surgery Patient With PAD / Carotid Stenosis, run by St. Josef Hospital Bochum at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Were Responders or Low-Responders of Antiplatelet Therapy as a Result of Whole Blood Aggregometry Testing (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2018.