Carotid Artery DiseaseNCT00587717
The Acute Effect of Statins on Inflammatory Markers of Athersclerotic Tissue
A study testing simvastatin in people with Carotid Artery Disease, run by Mayo Clinic.
Trial summary
This study is being done to determine if the acute administration of the drug Simvastatin reduces plaque tissue inflammation and plaque instability in patients undergoing carotid endarectomy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Disease
- What is being tested?
- simvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Sep 2002to Mar 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing carotid endarterectomy
- No previously known side effects of statins
- Patients who will sign an informed consent
- Age > 18 years old
- No signs of current infection
Who cannot join
- Patient hypersensitive to any component of this medication
- Patients with acute liver disease (AST> normal value)
- Patients with chronic liver disease (history of Hepatitis B or C)
- Patients with renal failure (creatinine > 3.0)
- Patients with unexplained muscle pains and aches
- Patients with rheumatoid arthritis
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- Patients with Lupus
- Current cancer treatment
- Patients on cyclosporin, digoxin, Itraconazole, Ketoconazole and other antifungal azoles, the macrolide antibiotics and antidepressant nefazodone
- Pregnant females
About this study
Official title: The Acute Effect of Inflammatory Markers of Atherosclerotic Plaque in Humans
This study is being done to determine if the acute administration of the drug Simvastatin reduces plaque tissue inflammation and plaque instability in patients undergoing carotid endarectomy
- Conditions
- Carotid Artery Disease
- Being tested
- simvastatin, placebo
- Medical subject headings
- Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simvastatinDrug
Also called Zocor
Two 80 mg pills simvastatin taken 24 hours prior to surgery
placeboDrug
take 2 80 mg pills placebo 24 hours prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Two 80 mg pills simvastatin taken 24 hours prior to surgery Receives: Drug: simvastatin |
| 2 | Placebo comparator | Two 80 mg pills placebo are taken 24 hours prior to surgery Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
This study is being done to see if giving the study drug, Simvastatin, quickly lessens the swelling of plaque tissue (tissue around your heart) and plaque movement in patients undergoing cqrotid endarterectomy procedure.
Measured: 24 prior to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2008 (estimated)
- Study startSep 2002
- Primary completionMar 2006
- Study completionMar 2006
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.
- More trials run by Mayo ClinicThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Investigators
- Amir Lerman, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00587717
- Sponsor's protocol ID
- 485-02
- Other IDs
- Merck #02005
- Status last verified
- Dec 2023
- First submitted
- 21 Dec 2007
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effect of Inflammatory Markers of Atherosclerotic Plaque in Humans
- ClinicalTrials.gov ID
- NCT00587717
- Acronym / sponsor ID
- 485-02
- Conditions
- Carotid Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Sep 2002
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 7 Jan 2008 (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.
This study is being done to determine if the acute administration of the drug Simvastatin reduces plaque tissue inflammation and plaque instability in patients undergoing carotid endarectomy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: simvastatinTwo 80 mg pills simvastatin taken 24 hours prior to surgery |
| 2 | Placebo comparator | Drug: placeboTwo 80 mg pills placebo are taken 24 hours prior to surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoing carotid endarterectomy
- No previously known side effects of statins
- Patients who will sign an informed consent
- Age > 18 years old
- No signs of current infection
Key exclusion criteria (10 listed)
- Patient hypersensitive to any component of this medication
- Patients with acute liver disease (AST> normal value)
- Patients with chronic liver disease (history of Hepatitis B or C)
- Patients with renal failure (creatinine > 3.0)
- Patients with unexplained muscle pains and aches
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 |
|---|---|---|
| simvastatinAlso: ZocorTwo 80 mg pills simvastatin taken 24 hours prior to surgery | Drug | 1 |
| placebotake 2 80 mg pills placebo 24 hours prior to surgery | Drug | 2 |
Primary outcome
This study is being done to see if giving the study drug, Simvastatin, quickly lessens the swelling of plaque tissue (tissue around your heart) and plaque movement in patients undergoing cqrotid endarterectomy procedure.
Time frame: 24 prior to surgery
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 12 Dec 2023.
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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.
Amir Lerman, MD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A study testing simvastatin in people with Carotid Artery Disease, run by Mayo Clinic.
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 5 inclusion and 10 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 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is being done to see if giving the study drug, Simvastatin, quickly lessens the swelling of plaque tissue (tissue around your heart) and plaque movement in patients undergoing cqrotid endarterectomy procedure. (time frame: 24 prior to surgery). 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 12 Dec 2023.