Carotid StenosisICARNCT02630862
Oxidative Stress and Oxysterols Profiling in Patients With Carotid Revascularization
A study testing Aspirin and aspirin plus dipyridamole in people with Carotid Stenosis and Cardiovascular Disease, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
The combination of aspirin and dipyridamole, two antiplatelet drugs, is approved in Italy for the secondary prevention of cerebral embolism in patients with carotid atherosclerosis. Besides antiplatelet activity, Dipyridamole has additional pharmacological action, including vasodilation and antioxidant properties. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Carotid Stenosis, Cardiovascular Disease, Atherosclerosis
- What is being tested?
- Aspirin and aspirin plus dipyridamole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2010to Dec 2014
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with carotid atherosclerosis eligible for carotid endoarterectomy (stenosis >= 70%) with previous TIA or Stroke
Who cannot join
- Congestive heart failure, chronic liver disease, chronic kidney disease (GFR < 60%), cancer, use of antioxidant supplements in the previous 3 months, autoimmune diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oxidative Stress and Oxysterols Profiling in Patients With Carotid Revascularization: Effect of Antithrombotic Treatment
The combination of aspirin and dipyridamole, two antiplatelet drugs, is approved in Italy for the secondary prevention of cerebral embolism in patients with carotid atherosclerosis.
Besides antiplatelet activity, Dipyridamole has additional pharmacological action, including vasodilation and antioxidant properties.
Read more
A role for oxidative stress has been suggested in acute cerebrovascular disease. In this study the investigators want to test the in vivo antioxidant activity of dipyridamole in patients who are candidate to take the drug under approved conditions of the Italian Drug Regulation Agency, i.e. secondary prevention of TIA/Stroke in patinets with carotid stenosis (>= 70%).
To test the hypothesis that dipyridamole acts as antioxidant in vivo, oxysterols (products of cholesterol autoxidation) and vitamin E are measured in plasma before and after 6 months therapy after carotid endoarterectomy. Since dipyridamole is approved as combination preparation with aspirin, a control group of patients taking aspirin alone is enrolled.
Outcome measures: plasma biomarkers (oxysterols and vitamin E) change at two time points: baseline and 6-months therapy.
Read the detailed description
Dipyridamole has been shown to act as potent antioxidant in vitro. The aim of the present study is to analyze if dipyridamole retains the antioxidant in vivo in man.
The investigators identified a clinical setting where dipyridamole is approved for clinical use, i.e. secondary prevention of stroke, to test the hypothesis that dipyridamole given orally could affect circulating markers of oxidative stress, in particular reduction in oxysterols (autoxidation products of cholesterol) and increase in vitamin E concentration.
Methods. Two arms are included in the study: a) dipyridamole plus aspirin (in Italy the use of dipyridamole is approved in combination with aspirin); b) aspirin alone as comparison arm. Patients eligible for endoarterectomy for the presence of carotid stenosis >= 70% are randomized in the two arms. The study is open labeled for the patient and clinical investigators who have in charge the patinets . The study is blinded for the technicians performing biomarker assessment and investigators responsible for data analysis.
Blood is taken at baseline (before surgery) and after six months of treatment. Oxysterol profiling and vitamin E are measured by isotope dilution gas chromatography and mass spectrometry.
- Conditions
- Carotid Stenosis, Cardiovascular Disease, Atherosclerosis, Stroke
- Being tested
- Aspirin, aspirin plus dipyridamole
- Keywords
- oxidative stress, atherosclerosis, carotid stenosis, oxysterols, vitamin E, lipid peroxidation, antioxidants, aspirin, dipyridamole
- Medical subject headings
- Carotid Stenosis, Cardiovascular Diseases, Atherosclerosis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Also called Cardioaspirin, 100 mg, acetylsalicylic acid, 100 mg
Aspirin is a standard and guidelines supported therapy for patients undergoing carotid endoarterectomy as secondary prevention measure of cardiovascular risk
aspirin plus dipyridamoleDrug
Also called aspirin 25 mg plus dipyridamole extended release 200 mg, aggrenox
the combination of aspirin plus dipyridamole is approved to lower the risk of stroke in people who have had a transient ischemic attack or stroke
| Study group | Role | What they receive |
|---|---|---|
| aspirin | Active comparator | acetylsalcylic acid 100 mg per day give orally for six months, starting the day of carotid endoartherectomy Receives: Drug: Aspirin |
| aspirin plus dipyridamole | Active comparator | acetylsalicylic acid 25 mg plus dipyridamole extended release 200 mg, combined in a capsule, per day starting the day of carotid endoartherectomy Receives: Drug: aspirin plus dipyridamole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of oxysterol measured by isotope dilution gas chromatography-mass spectrometry
Oxysterols are used here as markers of oxidative stress, i.e. increased oxidative stress is refected by increased oxysterols levels
Measured: 6-months
Level of alpha- and gamma-tocopherol (vitamin E isomers) by isotope dilution gas chromatography-mass spectrometry
Increased oxidative stress is expected to reduce the levels of of vitamin E isomers by consumption
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study startSep 2010
- Primary completionJun 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid StenosisStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Collaborators
- Civic Hospital, Italy
- Responsible party
- Principal investigator, Luigi Iuliano, University of Roma La Sapienza
- Investigators
- Giovanni Bertoletti, M.D., Principal investigator, Goretti Hospital, Latina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02630862
- Sponsor's protocol ID
- IULIANO_Carotids
- Acronym
- ICAR
- Status last verified
- Dec 2015
- First submitted
- 26 May 2015
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxidative Stress and Oxysterols Profiling in Patients With Carotid Revascularization: Effect of Antithrombotic Treatment
- ClinicalTrials.gov ID
- NCT02630862
- Acronym / sponsor ID
- ICAR / IULIANO_Carotids
- Conditions
- Carotid Stenosis, Cardiovascular Disease, Atherosclerosis, Stroke
- Keywords
- oxidative stress, atherosclerosis, carotid stenosis, oxysterols, vitamin E, lipid peroxidation, antioxidants, aspirin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Collaborators
- Civic Hospital, Italy
- Study start
- Sep 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 15 Dec 2015 (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.
The combination of aspirin and dipyridamole, two antiplatelet drugs, is approved in Italy for the secondary prevention of cerebral embolism in patients with carotid atherosclerosis.
Besides antiplatelet activity, Dipyridamole has additional pharmacological action, including vasodilation and antioxidant properties.
A role for oxidative stress has been suggested in acute cerebrovascular disease. In this study the investigators want to test the in vivo antioxidant activity of dipyridamole in patients who are candidate to take the drug under approved conditions of the Italian Drug Regulation Agency, i.e. secondary prevention of TIA/Stroke in patinets with carotid stenosis (>= 70%).
To test the hypothesis that dipyridamole acts as antioxidant in vivo, oxysterols (products of cholesterol autoxidation) and vitamin E are measured in plasma before and after 6 months therapy after carotid endoarterectomy. Since dipyridamole is approved as combination preparation with aspirin, a control group of patients taking aspirin alone is enrolled.
Outcome measures: plasma biomarkers (oxysterols and vitamin E) change at two time points: baseline and 6-months therapy.
Detailed description
Dipyridamole has been shown to act as potent antioxidant in vitro. The aim of the present study is to analyze if dipyridamole retains the antioxidant in vivo in man.
The investigators identified a clinical setting where dipyridamole is approved for clinical use, i.e. secondary prevention of stroke, to test the hypothesis that dipyridamole given orally could affect circulating markers of oxidative stress, in particular reduction in oxysterols (autoxidation products of cholesterol) and increase in vitamin E concentration.
Methods. Two arms are included in the study: a) dipyridamole plus aspirin (in Italy the use of dipyridamole is approved in combination with aspirin); b) aspirin alone as comparison arm. Patients eligible for endoarterectomy for the presence of carotid stenosis >= 70% are randomized in the two arms. The study is open labeled for the patient and clinical investigators who have in charge the patinets . The study is blinded for the technicians performing biomarker assessment and investigators responsible for data analysis.
Blood is taken at baseline (before surgery) and after six months of treatment. Oxysterol profiling and vitamin E are measured by isotope dilution gas chromatography and mass spectrometry.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aspirin | Active comparator | Drug: Aspirinacetylsalcylic acid 100 mg per day give orally for six months, starting the day of carotid endoartherectomy |
| aspirin plus dipyridamole | Active comparator | Drug: aspirin plus dipyridamoleacetylsalicylic acid 25 mg plus dipyridamole extended release 200 mg, combined in a capsule, per day starting the day of carotid endoartherectomy |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with carotid atherosclerosis eligible for carotid endoarterectomy (stenosis >= 70%) with previous TIA or Stroke
Key exclusion criteria (1 listed)
- Congestive heart failure, chronic liver disease, chronic kidney disease (GFR < 60%), cancer, use of antioxidant supplements in the previous 3 months, autoimmune diseases
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 |
|---|---|---|
| AspirinAlso: Cardioaspirin, 100 mg, acetylsalicylic acid, 100 mgAspirin is a standard and guidelines supported therapy for patients undergoing carotid endoarterectomy as secondary prevention measure of cardiovascular risk | Drug | aspirin |
| aspirin plus dipyridamoleAlso: aspirin 25 mg plus dipyridamole extended release 200 mg, aggrenoxthe combination of aspirin plus dipyridamole is approved to lower the risk of stroke in people who have had a transient ischemic attack or stroke | Drug | aspirin plus dipyridamole |
Primary outcome
Level of oxysterol measured by isotope dilution gas chromatography-mass spectrometry
Time frame: 6-months
Oxysterols are used here as markers of oxidative stress, i.e. increased oxidative stress is refected by increased oxysterols levels
Level of alpha- and gamma-tocopherol (vitamin E isomers) by isotope dilution gas chromatography-mass spectrometry
Time frame: 6-months
Increased oxidative stress is expected to reduce the levels of of vitamin E isomers by consumption
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 15 Dec 2015.
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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.
Giovanni Bertoletti, M.D. principal investigator
Goretti Hospital, Latina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aspirin and aspirin plus dipyridamole in people with Carotid Stenosis and Cardiovascular Disease, run by University of Roma La Sapienza 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 1 inclusion and 1 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 15 Dec 2015. 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?
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?
Level of oxysterol measured by isotope dilution gas chromatography-mass spectrometry (time frame: 6-months). The study lists 2 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 15 Dec 2015.