Carotid Artery DiseaseARSNCT01449617
Residual Platelet Reactivity in Patients on Antiplatelet Therapy After Carotid Angioplasty With Stenting
An observational study of Carotid Artery Disease, run by Azienda Ospedaliera di Perugia at 1 site in Italy.
Trial summary
A carotid stenosis is treated with invasive procedures of revascularization when the lumen is reduced by more than 70% or when the lumen is reduced by more than 50% in patients who have had symptoms attributable to the affected carotid district in last the 6 months. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carotid Artery Disease
- What is being tested?
- Aspirin plus clopidogrel
- How many people
- 272 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2010to Mar 2016
- Phase
- Observational
- 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
Study population: 506 patients undergoing stenting for critical carotid stenosis, either symptomatic (previous events of cerebral ischemia) or asymptomatic, undergoing CAS.
Who may be able to join
- Informed written consent
- No contraindications to dual-antiplatelet treatment
Who cannot join
- Age < 18 or > 80 years old
- Use of oral anticoagulants
- Use of dipyridamole, cilostazol, NSAIDs
- Myeloproliferative syndrome or paraproteinemia
- Liver or kidney failure
- Thrombocytopathies
- Platelets count < 100000 or > 450000/µl
- Haemoglobin < 8g/dl
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliera di Perugia
Perugia, Italy, 06123
Massimo Lenti, Dr., 075 5783989, grespa@unipg.it
Paolo Gresele, Prof.
About this study
Official title: Observational Study on Predictive Value for Vascular Events of Residual Platelet Aggregation in Patients on Antiplatelet Therapy After Carotid Angioplasty With Stenting
A carotid stenosis is treated with invasive procedures of revascularization when the lumen is reduced by more than 70% or when the lumen is reduced by more than 50% in patients who have had symptoms attributable to the affected carotid district in last the 6 months.
Two options for the treatment of patients with carotid stenosis exist currently: the traditional surgical intervention of removal of the plaque by carotid endoarterectomy (CEA)and percutaneous transluminal carotid angioplasty with a balloon associated to the positioning of a stent through a catheter brought directly in the carotid artery (CAS).
Read more
The main complication of both the procedures is early thrombosis, a phenomenon in which platelets play a central role. The importance of an effective inhibition of platelet activation in these patients has been widely demonstrated.
Clinical studies in patients undergoing PTCA have demonstrated that the optimal treatment for the prevention of stent thrombosis is a dual antiplatelet regimen with aspirin plus clopidogrel, as compared with the single drugs. Given that no specific clinical trial has assessed the best antiplatelet therapeutic regimen in CAS with stenting, by extension from these findings in ischemic heart disease CAS patients are treated with aspirin plus clopidogrel.
Several studies have demonstrated that an elevated residual platelet reactivity despite treatment with clopidogrel is associated to an increased risk of major adverse cardiovascular events (MACE) after stenting for coronary disease.
No data are instead available on the possible predictive value of residual platelet reactivity for the incidence of ischemic cardiovascular events in patients with atherosclerotic carotid disease undergoing CAS with stenting.
Aim of the study will be to assess the predictive value of residual platelet reactivity, as measured by different laboratory tests in patients undergoing CAS with stenting and treated with aspirin plus clopidogrel, for the incidence of cardiovascular complications (major adverse ischemic events).
Read the detailed description
STUDY DESIGN The study will enroll 110 patients undergoing stenting for critical carotid stenosis, either symptomatic (previous events of cerebral ischemia) or asymptomatic, undergoing CAS.
All patients undergoing CAS in our Center and that fit the predefined Criteria will be enrolled in the study. Dual-antiplatelet treatment with aspirin and clopidogrel will be administered to all patients with the same modalities in use for coronary heart disease patients undergoing PTCA.
Implanted stents after CAS will be in all patients bare metal stents (BMS) and therefore, by analogy with the studies in ACS, the duration of dual-antiplatelet treatment will be of one month; later all patients will be continued indefinitely on aspirin.
Clopidogrel, will be started 48 hours before the procedure with a loading dose of of 300mg and continued at 75mg/day; aspirin will be given at the dose of 100-325mg/day.
Platelet reactivity assessment will be carried-out:
- before intervention,
- after 1 week of treatment,
- after 1 month of treatment
- after 1 year. All patients will be recalled for clinical examination at 1 and 6 months and at 1 year.
- Conditions
- Carotid Artery Disease
- Being tested
- Aspirin plus clopidogrel
- Keywords
- Carotid stenosis, Aspirin plus Clopidogrel, Residual platelet reactivity
- Medical subject headings
- Carotid Artery Diseases, Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin plus clopidogrelDrug
Also called Cardioaspirina, Plavix
Clopidogrel, will be started 48 hours before the procedure with a loading dose of of 300mg and continued at 75mg/day.
Aspirin will be given at the dose of 100-325mg/day.
| Study group | Role | What they receive |
|---|---|---|
| Aspirin plus clopidogrel | Patients undergoing stenting for critical carotid stenosis, either symptomatic (previous events of cerebral ischemia) or asymptomatic, undergoing CAS. Receives: Drug: Aspirin plus clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Platelet reactivity
assessed by VerifyNow (ASA and P2Y12 cartridges), Multiplate (ASA and ADP cartridges), PFA100 (coll/epi; coll/adp; coll/P2Y12 cartridges)
Measured: 1, 6 and 12 months
Change in Occurrence of stroke
assessed by subsequent follow-up
Measured: 1, 6 and 12 months
Change in Occurence of myocardial infarction
assessed by subsequent follow-up
Measured: 1, 6 and 12 months
Change in occurrence of lower limb ischemia
assessed by subsequent follow-up
Measured: 1, 6 and 12 months
Secondary outcomes (1)
Change in Incidence of restenosis
assessed by Eco Color Doppler
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2011 (estimated)
- Study startAug 2010
- Primary completionJan 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery DiseaseStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 272 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera di Perugia
- Sponsor type
- University, hospital or other
- Collaborators
- University Of Perugia
- Responsible party
- Principal investigator, Paolo Gresele, Azienda Ospedaliera di Perugia
- Investigators
- Paolo Gresele, Prof., Principal investigator, University Of Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01449617
- Sponsor's protocol ID
- UniPG
- Other IDs
- CEAS
- Acronym
- ARS
- Status last verified
- Jul 2014
- First submitted
- 23 Jun 2011
- Last updated
- 17 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on Predictive Value for Vascular Events of Residual Platelet Aggregation in Patients on Antiplatelet Therapy After Carotid Angioplasty With Stenting
- ClinicalTrials.gov ID
- NCT01449617
- Acronym / sponsor ID
- ARS / UniPG
- Conditions
- Carotid Artery Disease
- Keywords
- Carotid stenosis, Aspirin plus Clopidogrel, Residual platelet reactivity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 272 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera di PerugiaUniversity, hospital or other
- Collaborators
- University Of Perugia
- Study start
- Aug 2010
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 10 Oct 2011 (estimated)
- 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.
A carotid stenosis is treated with invasive procedures of revascularization when the lumen is reduced by more than 70% or when the lumen is reduced by more than 50% in patients who have had symptoms attributable to the affected carotid district in last the 6 months.
Two options for the treatment of patients with carotid stenosis exist currently: the traditional surgical intervention of removal of the plaque by carotid endoarterectomy (CEA)and percutaneous transluminal carotid angioplasty with a balloon associated to the positioning of a stent through a catheter brought directly in the carotid artery (CAS).
The main complication of both the procedures is early thrombosis, a phenomenon in which platelets play a central role. The importance of an effective inhibition of platelet activation in these patients has been widely demonstrated.
Clinical studies in patients undergoing PTCA have demonstrated that the optimal treatment for the prevention of stent thrombosis is a dual antiplatelet regimen with aspirin plus clopidogrel, as compared with the single drugs. Given that no specific clinical trial has assessed the best antiplatelet therapeutic regimen in CAS with stenting, by extension from these findings in ischemic heart disease CAS patients are treated with aspirin plus clopidogrel.
Several studies have demonstrated that an elevated residual platelet reactivity despite treatment with clopidogrel is associated to an increased risk of major adverse cardiovascular events (MACE) after stenting for coronary disease.
No data are instead available on the possible predictive value of residual platelet reactivity for the incidence of ischemic cardiovascular events in patients with atherosclerotic carotid disease undergoing CAS with stenting.
Aim of the study will be to assess the predictive value of residual platelet reactivity, as measured by different laboratory tests in patients undergoing CAS with stenting and treated with aspirin plus clopidogrel, for the incidence of cardiovascular complications (major adverse ischemic events).
Detailed description
STUDY DESIGN The study will enroll 110 patients undergoing stenting for critical carotid stenosis, either symptomatic (previous events of cerebral ischemia) or asymptomatic, undergoing CAS.
All patients undergoing CAS in our Center and that fit the predefined Criteria will be enrolled in the study. Dual-antiplatelet treatment with aspirin and clopidogrel will be administered to all patients with the same modalities in use for coronary heart disease patients undergoing PTCA.
Implanted stents after CAS will be in all patients bare metal stents (BMS) and therefore, by analogy with the studies in ACS, the duration of dual-antiplatelet treatment will be of one month; later all patients will be continued indefinitely on aspirin.
Clopidogrel, will be started 48 hours before the procedure with a loading dose of of 300mg and continued at 75mg/day; aspirin will be given at the dose of 100-325mg/day.
Platelet reactivity assessment will be carried-out:
- before intervention,
- after 1 week of treatment,
- after 1 month of treatment
- after 1 year. All patients will be recalled for clinical examination at 1 and 6 months and at 1 year.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aspirin plus clopidogrel | – | Drug: Aspirin plus clopidogrelPatients undergoing stenting for critical carotid stenosis, either symptomatic (previous events of cerebral ischemia) or asymptomatic, undergoing CAS. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 506 patients undergoing stenting for critical carotid stenosis, either symptomatic (previous events of cerebral ischemia) or asymptomatic, undergoing CAS.
Key inclusion criteria (2 listed)
- Informed written consent
- No contraindications to dual-antiplatelet treatment
Key exclusion criteria (8 listed)
- Age < 18 or > 80 years old
- Use of oral anticoagulants
- Use of dipyridamole, cilostazol, NSAIDs
- Myeloproliferative syndrome or paraproteinemia
- Liver or kidney failure
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 |
|---|---|---|
| Aspirin plus clopidogrelAlso: Cardioaspirina, PlavixClopidogrel, will be started 48 hours before the procedure with a loading dose of of 300mg and continued at 75mg/day. Aspirin will be given at the dose of 100-325mg/day. | Drug | Aspirin plus clopidogrel |
Primary outcome
Change in Platelet reactivity
Time frame: 1, 6 and 12 months
assessed by VerifyNow (ASA and P2Y12 cartridges), Multiplate (ASA and ADP cartridges), PFA100 (coll/epi; coll/adp; coll/P2Y12 cartridges)
Change in Occurrence of stroke
Time frame: 1, 6 and 12 months
assessed by subsequent follow-up
Change in Occurence of myocardial infarction
Time frame: 1, 6 and 12 months
assessed by subsequent follow-up
Change in occurrence of lower limb ischemia
Time frame: 1, 6 and 12 months
assessed by subsequent follow-up
1 secondary outcome
Change in Incidence of restenosis
Time frame: 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2014.
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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.
Paolo Gresele, Prof. principal investigator
University Of Perugia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Disease, run by Azienda Ospedaliera di Perugia at 1 site in Italy.
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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 17 Jul 2014. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paolo Gresele, Prof. (075 5783989 ext. 0039, grespa@unipg.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Platelet reactivity (time frame: 1, 6 and 12 months). The study lists 4 primary outcomes in all. 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 17 Jul 2014.