Carotid StenosisPhase 4ARMYDA-CARONCT01572623
Clopidogrel and Atorvastatin Treatment During Carotid Artery Stenting
A Phase 4 study testing Clopidogrel and Atorvastatin in people with Carotid Stenosis, run by Campus Bio-Medico University at 1 site in Italy.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of two different loading doses of Clopidogrel and a reloading of Atorvastatin in the prevention of periprocedural ischemic brain damage in patients undergoing carotid angioplasty. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Carotid Stenosis
- What is being tested?
- Clopidogrel and Atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2011to Sep 2012
- Phase
- Phase 4
- 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
- symptomatic and asymptomatic patients with finding of significant carotid stenosis
Who cannot join
- patients with acute injuries to the baseline MRI of the brain,
- patients with active bleeding,
- contraindications to statin therapy and MRI contraindications (pacemaker/claustrophobic).
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Campus Bio Medico University of Rome
Rome, RM, 00128
Patti Giuseppe, MD, 06225411899, g.patti@unicampus.it
Melfi Rosetta, MD
About this study
Official title: Efficacy of Two Different Pre-Intervention Therapeutic Strategies With Clopidogrel and Atorvastatin for the Prevention of Cerebral Damage During Carotid Artery Stenting. Armyda-Caro Randomized Trial.
The purpose of this study is to evaluate the efficacy and safety of two different loading doses of Clopidogrel and a reloading of Atorvastatin in the prevention of periprocedural ischemic brain damage in patients undergoing carotid angioplasty.
- Conditions
- Carotid Stenosis
- Being tested
- Clopidogrel, Atorvastatin
- Keywords
- Therapeutic strategies for carotid artery stenting
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClopidogrelDrug
Loading dose of Clopidogrel 600 mg versus 300 mg before carotid artery stenting
AtorvastatinDrug
Reloading dose of Atorvastatin (80 mg at 12 hours and 40 mg at 6-8 hours before carotid artery stenting) versus no reload.
| Study group | Role | What they receive |
|---|---|---|
| Antiplatelet before carotid artery stenting | Active comparator | Clopidogrel 600 mg after carotid artery stenting Receives: Drug: Clopidogrel |
| Statin therapy before carotid artery stenting | Active comparator | Reloading dose of Atorvastatin (80 mg at 12 hours and 40 mg at 6-8 hours before carotid artery stenting) versus no reload. Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral damage
Incidence of stroke at 30 days (defined as a neurologic deficit lasting> 24 hours with MRI evidence of cerebral ischemic injury) or transient ischemic attack (TIA);
- Evidence of new onset acute ischemic lesions on MRI-DWI brain after the procedure, even in the absence of specific neurological symptoms
Measured: 30 days
Secondary outcomes (1)
Bleeding complications
Effect on the 30-day major and minor bleeding (according to the TIMI definition);
- Incidence of post-procedural vascular complications (pseudoaneurysm, AV fistula, hematoma> 5 cm).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2012 (estimated)
- Study startJul 2011
- Primary completionSep 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patti Giuseppe, Campus Bio-Medico University
- Investigators
- Patti Giuseppe, MD, Principal investigator, Campus Bio-Medico University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01572623
- Sponsor's protocol ID
- 2011-005330-18
- Acronym
- ARMYDA-CARO
- Status last verified
- Apr 2012
- First submitted
- 4 Apr 2012
- Last updated
- 6 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Patti G, Tomai F, Melfi R, Ricottini E, Macri M, Sedati P, Giardina A, Aurigemma C, Leporace M, D'Ambrosio A, Di Sciascio G. Strategies of clopidogrel load and atorvastatin reload to prevent ischemic cerebral events in patients undergoing protected carotid stenting. Results of the randomized ARMYDA-9 CAROTID (Clopidogrel and Atorvastatin Treatment During Carotid Artery Stenting) study. J Am Coll Cardiol. 2013 Apr 2;61(13):1379-87. doi: 10.1016/j.jacc.2013.01.015. Epub 2013 Mar 9.
PubMed 23490041
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Two Different Pre-Intervention Therapeutic Strategies With Clopidogrel and Atorvastatin for the Prevention of Cerebral Damage During Carotid Artery Stenting. Armyda-Caro Randomized Trial.
- ClinicalTrials.gov ID
- NCT01572623
- Acronym / sponsor ID
- ARMYDA-CARO / 2011-005330-18
- Conditions
- Carotid Stenosis
- Keywords
- Therapeutic strategies for carotid artery stenting
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 6 Apr 2012 (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 purpose of this study is to evaluate the efficacy and safety of two different loading doses of Clopidogrel and a reloading of Atorvastatin in the prevention of periprocedural ischemic brain damage in patients undergoing carotid angioplasty.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antiplatelet before carotid artery stenting | Active comparator | Drug: ClopidogrelClopidogrel 600 mg after carotid artery stenting |
| Statin therapy before carotid artery stenting | Active comparator | Drug: AtorvastatinReloading dose of Atorvastatin (80 mg at 12 hours and 40 mg at 6-8 hours before carotid artery stenting) versus no reload. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- symptomatic and asymptomatic patients with finding of significant carotid stenosis
Key exclusion criteria (3 listed)
- patients with acute injuries to the baseline MRI of the brain,
- patients with active bleeding,
- contraindications to statin therapy and MRI contraindications (pacemaker/claustrophobic).
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 |
|---|---|---|
| ClopidogrelLoading dose of Clopidogrel 600 mg versus 300 mg before carotid artery stenting | Drug | Antiplatelet before carotid artery stenting |
| AtorvastatinReloading dose of Atorvastatin (80 mg at 12 hours and 40 mg at 6-8 hours before carotid artery stenting) versus no reload. | Drug | Statin therapy before carotid artery stenting |
Primary outcome
Cerebral damage
Time frame: 30 days
Incidence of stroke at 30 days (defined as a neurologic deficit lasting> 24 hours with MRI evidence of cerebral ischemic injury) or transient ischemic attack (TIA); - Evidence of new onset acute ischemic lesions on MRI-DWI brain after the procedure, even in the absence of specific neurological symptoms
1 secondary outcome
Bleeding complications
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2012.
- Derived from this study: PubMed 23490041Patti G, Tomai F, Melfi R, Ricottini E, Macri M, Sedati P, Giardina A, Aurigemma C, Leporace M, D'Ambrosio A, Di Sciascio G. Strategies of clopidogrel load and atorvastatin reload to prevent ischemic cerebral events in patients undergoing protected carotid stenting. Results of the randomized ARMYDA-9 CAROTID (Clopidogrel and Atorvastatin Treatment During Carotid Artery Stenting) study. J Am Coll Cardiol. 2013 Apr 2;61(13):1379-87. doi: 10.1016/j.jacc.2013.01.015. Epub 2013 Mar 9.
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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.
Patti Giuseppe, MD principal investigator
Campus Bio-Medico University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clopidogrel and Atorvastatin in people with Carotid Stenosis, run by Campus Bio-Medico University 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 3 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 6 Apr 2012. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Giuseppe Patti, MD (06225411899, g.patti@unicampus.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral damage (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01572623, which also lists 1 linked publication.
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 6 Apr 2012.