AtherosclerosisPhase 3NCT00115817
The Effects of Atorvastatin in Patients With Atherosclerosis
A Phase 3 study testing Atorvastatin in people with Atherosclerosis, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the effects of Atorvastatin. The investigators want to find out if atorvastatin has other helpful qualities. The investigators are interested in finding out if medicines like atorvastatin are useful even in people who do not have high levels of bad cholesterol and would like to… Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- Atorvastatin
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Mar 2007
- Phase
- Phase 3
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects aged 21 to 80 years
- Modified NCEP ATPIII guideline criteria should be met to initiate statin therapy
- Known stable atherosclerotic disease (diagnosed coronary, peripheral or carotid vascular disease) and/or diabetes mellitus (a coronary heart disease equivalent)
- Written informed consent with prior primary care physician approval
Who cannot join
- Inability to give consent
- Pregnancy
- Inability to withdraw statin therapy for a 6 week period
- Prior history of intolerance to statins
- Hepatic dysfunction (ALT or GGT > 2 times the upper limit of normal
- Elevated muscle enzymes (CK > 3 times the upper limit of normal)
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- History of myopathy or myositis
- Evidence of active inflammatory, infectious or neoplastic disease
- Use of cyclosporine, fibric acid derivatives, nicotinic acid, erythromycin, azole antifungals, prednisone or any immunosuppressant
- Coronary artery bypass graft surgery or percutaneous coronary intervention within the preceding 3 months
- Acute coronary syndrome or myocardial infarction within the preceding 3 months
- History of life-threatening arrhythmias without an implantable cardioverter defibrillator
- Severe chronic congestive heart failure
- Severe anemia
- Serum creatinine > 3 mg/dl
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Womens Hospital
Boston, Massachusetts, 02115
About this study
Official title: The Effects of Atorvastatin on the Rho/Rho Kinase Pathway in Patients With Atherosclerosis
The purpose of the study is to evaluate the effects of Atorvastatin.
The investigators want to find out if atorvastatin has other helpful qualities. The investigators are interested in finding out if medicines like atorvastatin are useful even in people who do not have high levels of bad cholesterol and would like to understand other mechanisms by which this medicine helps prevent further blood vessel disease.
Hypotheses:
- Atorvastatin reduces Rho kinase activity (in leukocytes) rapidly, within days, in patients with atherosclerosis.
- Any decrease in Rho kinase activity with statin therapy will be accompanied by improvement in familiar markers of atherosclerosis.
Read the detailed description
The total study period is approximately 14 + 28 days. There will be a total of 5 visits: a screening visit, followed by visits at 0, 7, 14 and 28 days. (These dates may vary by approximately 2 days in the event of a weekend or holiday). At the baseline visit (day 0), patients will be randomly assigned to atorvastatin 10 mg/day (given as 1 placebo pill + 1 10mg pill), 80 mg/day (given as 2 40mg pills) or placebo (given as 2 placebo pills). Subjects will be asked to take 2 pills every day at the same time between 7 p.m. and 8 p.m., and record in a calendar/diary any side effects, missed doses, change in concomitant medication, or any other pertinent information. At each visit, blood will be collected for the following tests: 1) Lipid profile, 2) C-Reactive protein, 3) Rho kinase expression and activity in leukocytes, 4) nitric oxide synthase (NOS) expression/activity in platelets, and 5) leukocyte/monocyte adhesion/migration assays. Blood for hepatic and muscle tests (ALT, GGT and CK) to monitor for side effects will be determined at baseline and at 28 days and as clinically indicated. At each visit, patients will be questioned about compliance with study medication and any side effects. All patients will be encouraged to adhere to the NCEP-ATPIII recommended therapeutic life style. Subjects will be asked to resume any statin medications they were taking prior to enrollment upon completion of the study.
- Conditions
- Atherosclerosis
- Being tested
- Atorvastatin
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2005 (estimated)
- Study startJun 2005
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 36 participants
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Andrew Selwyn, MD, Principal investigator, Brigham and Womens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00115817
- Sponsor's protocol ID
- 2005P-000416
- Status last verified
- Apr 2007
- First submitted
- 26 Jun 2005
- Last updated
- 24 Apr 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Atorvastatin on the Rho/Rho Kinase Pathway in Patients With Atherosclerosis
- ClinicalTrials.gov ID
- NCT00115817
- Acronym / sponsor ID
- 2005P-000416
- Conditions
- Atherosclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Jun 2005
- Study completion
- Mar 2007 (actual)
- First posted
- 27 Jun 2005 (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 the study is to evaluate the effects of Atorvastatin.
The investigators want to find out if atorvastatin has other helpful qualities. The investigators are interested in finding out if medicines like atorvastatin are useful even in people who do not have high levels of bad cholesterol and would like to understand other mechanisms by which this medicine helps prevent further blood vessel disease.
Hypotheses:
- Atorvastatin reduces Rho kinase activity (in leukocytes) rapidly, within days, in patients with atherosclerosis.
- Any decrease in Rho kinase activity with statin therapy will be accompanied by improvement in familiar markers of atherosclerosis.
Detailed description
The total study period is approximately 14 + 28 days. There will be a total of 5 visits: a screening visit, followed by visits at 0, 7, 14 and 28 days. (These dates may vary by approximately 2 days in the event of a weekend or holiday). At the baseline visit (day 0), patients will be randomly assigned to atorvastatin 10 mg/day (given as 1 placebo pill + 1 10mg pill), 80 mg/day (given as 2 40mg pills) or placebo (given as 2 placebo pills). Subjects will be asked to take 2 pills every day at the same time between 7 p.m. and 8 p.m., and record in a calendar/diary any side effects, missed doses, change in concomitant medication, or any other pertinent information. At each visit, blood will be collected for the following tests: 1) Lipid profile, 2) C-Reactive protein, 3) Rho kinase expression and activity in leukocytes, 4) nitric oxide synthase (NOS) expression/activity in platelets, and 5) leukocyte/monocyte adhesion/migration assays. Blood for hepatic and muscle tests (ALT, GGT and CK) to monitor for side effects will be determined at baseline and at 28 days and as clinically indicated. At each visit, patients will be questioned about compliance with study medication and any side effects. All patients will be encouraged to adhere to the NCEP-ATPIII recommended therapeutic life style. Subjects will be asked to resume any statin medications they were taking prior to enrollment upon completion of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female subjects aged 21 to 80 years
- Modified NCEP ATPIII guideline criteria should be met to initiate statin therapy
- Known stable atherosclerotic disease (diagnosed coronary, peripheral or carotid vascular disease) and/or diabetes mellitus (a coronary heart disease equivalent)
- Written informed consent with prior primary care physician approval
Key exclusion criteria (15 listed)
- Inability to give consent
- Pregnancy
- Inability to withdraw statin therapy for a 6 week period
- Prior history of intolerance to statins
- Hepatic dysfunction (ALT or GGT > 2 times the upper limit of normal
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 |
|---|---|---|
| Atorvastatin | Drug | – |
Primary outcome
Not reported in the source record.
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 24 Apr 2007.
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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.
Andrew Selwyn, MD principal investigator
Brigham and Womens Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atorvastatin in people with Atherosclerosis, run by Brigham and Women's Hospital at 1 site in United States.
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 4 inclusion and 15 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 24 Apr 2007. 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 United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
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 24 Apr 2007.