AtherosclerosisPhase 4DCATNCT00640744
Effect of Short Term Atorvastatin Treatment,80mg/Day on Early Regression of Carotid Artery Atherosclerotic Lesions
A Phase 4 study testing Atorvastatin in people with Atherosclerosis, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Atherosclerosis is a disease in which the blood vessels become blocked by plaques (consisting of fat, calcification, and fibrous tissue), reducing blood flow to vital organs and tissues.Blockage of the carotid arteries in the neck is a major cause of stroke. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Feb 2010
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women
- >18 yrs old
- Expected to have an endarterectomy on each carotid artery
- No contraindications for atorvastatin
- Stable cardiovascular health
- Lipid lowering treatment less than 6 mo duration
Show all 9Show fewer
- Diabetic included if diabetes is controlled
- Patient is not claustrophobic
- Patient has evaluable carotid plaques.
Who cannot join
- Patient has had previous carotid endarterectomy,stenting, or other procedure
- Unstable cardiovascular status
- Hypersensitivity to statin therapy
- Neck anatomy preventing acquiring bilateral evaluable plaques
- Weight over 285 lbs.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Joel D Morrisett, PhD, 713-798-4164, morriset@bcm.tmc.edu
Addison Taylor, MD/PhD, 713-798-4721, ataylor@bcm.tmc.edu
About this study
Official title: Phase 3 Study of Atorvastatin Effects on Carotid Atherosclerosis
Atherosclerosis is a disease in which the blood vessels become blocked by plaques (consisting of fat, calcification, and fibrous tissue), reducing blood flow to vital organs and tissues.Blockage of the carotid arteries in the neck is a major cause of stroke. One way of treating carotid atherosclerosis is with cholesterol-lowering drugs called statins. Statins have been shown to reduce the risk of coronary heart disease by 24-40% and risk pf stroke by 11-30%.The purpose of this study is to determine if short term treatment with atorvastatin causes early favorable changes in the plaques that block blood flow through the carotid arteries. These changes can be assessed 1) by taking pictures of the carotid arteries with MRI and Ultrasound before and after statin treatment, and 2) by special studies of the plaques removed from the carotid arteries by surgery.
Read the detailed description
Candidates for bilateral carotid endarterectomy (CEA) who meet study criteria will provide informed consent before their randomization. Before the first CEA, the patient will have MRI, US, and EBCT exams of both carotids. The most occlusive plaque will be resected at the first CEA. The patient will then receive atorvastatin 80 mg/day for 3 months. Then the second CEA will be performed. Six weeks after the second CEA, the patient will have another MRI, US, and EBCT exam and at 6, 12, and 18 months thereafter. This protocol will allow comparison of the characteristics of the plaque that has been exposed to drug vs the plaque that has not been exposed. It will also allow monitoring the effect of drug on restenosis after surgery.
- Conditions
- Atherosclerosis
- Being tested
- Atorvastatin
- Keywords
- Atherogenesis, Atheroma, Arteriosclerosis
- Medical subject headings
- Atherosclerosis, Plaque, Atherosclerotic, Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Atorvastatin 80 mg tablet/day for 3 months
| Study group | Role | What they receive |
|---|---|---|
| A | Other | An untreated carotid plaque will be obtained at the first endarterectomy. Atorvastatin 80mg will be administered for 3 months. The contralateral (treated) plaque will be obtained at the second endarterectomy. Hence, each patient will be his/her own control Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in carotid plaque composition as assessed by MRI and histology
Measured: 3 months
Secondary outcomes (2)
Changes content of cells, proteins and genes in carotid plaque
Measured: 3 months
Changes in content of selected proteins and their encoding genes in carotid plaques
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2008 (estimated)
- Study startFeb 2006
- Primary completionNov 2009 (estimated)
- Study completionFeb 2010 (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 AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Joel D Morrisett, PhD, Principal investigator, Baylor College of MedicineAddison M Taylor, MD, PhD, Study director, Baylor College of MedicineWilliam Insull, MD, Study chair, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00640744
- Sponsor's protocol ID
- H-18077
- Other IDs
- HL 063090
- Acronym
- DCAT
- Status last verified
- Dec 2010
- First submitted
- 2 Jan 2008
- Last updated
- 7 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Choudhary S, Higgins CL, Chen IY, Reardon M, Lawrie G, Vick GW 3rd, Karmonik C, Via DP, Morrisett JD. Quantitation and localization of matrix metalloproteinases and their inhibitors in human carotid endarterectomy tissues. Arterioscler Thromb Vasc Biol. 2006 Oct;26(10):2351-8. doi: 10.1161/01.ATV.0000239461.87113.0b. Epub 2006 Aug 3.
PubMed 16888239
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of Atorvastatin Effects on Carotid Atherosclerosis
- ClinicalTrials.gov ID
- NCT00640744
- Acronym / sponsor ID
- DCAT / H-18077
- Conditions
- Atherosclerosis
- Keywords
- Atherogenesis, Atheroma, Arteriosclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Feb 2006
- Primary completion
- Nov 2009 (estimated)
- Study completion
- Feb 2010 (estimated)
- First posted
- 21 Mar 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.
Atherosclerosis is a disease in which the blood vessels become blocked by plaques (consisting of fat, calcification, and fibrous tissue), reducing blood flow to vital organs and tissues.Blockage of the carotid arteries in the neck is a major cause of stroke. One way of treating carotid atherosclerosis is with cholesterol-lowering drugs called statins. Statins have been shown to reduce the risk of coronary heart disease by 24-40% and risk pf stroke by 11-30%.The purpose of this study is to determine if short term treatment with atorvastatin causes early favorable changes in the plaques that block blood flow through the carotid arteries. These changes can be assessed 1) by taking pictures of the carotid arteries with MRI and Ultrasound before and after statin treatment, and 2) by special studies of the plaques removed from the carotid arteries by surgery.
Detailed description
Candidates for bilateral carotid endarterectomy (CEA) who meet study criteria will provide informed consent before their randomization. Before the first CEA, the patient will have MRI, US, and EBCT exams of both carotids. The most occlusive plaque will be resected at the first CEA. The patient will then receive atorvastatin 80 mg/day for 3 months. Then the second CEA will be performed. Six weeks after the second CEA, the patient will have another MRI, US, and EBCT exam and at 6, 12, and 18 months thereafter. This protocol will allow comparison of the characteristics of the plaque that has been exposed to drug vs the plaque that has not been exposed. It will also allow monitoring the effect of drug on restenosis after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Other | Drug: AtorvastatinAn untreated carotid plaque will be obtained at the first endarterectomy. Atorvastatin 80mg will be administered for 3 months. The contralateral (treated) plaque will be obtained at the second endarterectomy. Hence, each patient will be his/her own control |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men or women
- >18 yrs old
- Expected to have an endarterectomy on each carotid artery
- No contraindications for atorvastatin
- Stable cardiovascular health
Key exclusion criteria (5 listed)
- Patient has had previous carotid endarterectomy,stenting, or other procedure
- Unstable cardiovascular status
- Hypersensitivity to statin therapy
- Neck anatomy preventing acquiring bilateral evaluable plaques
- Weight over 285 lbs.
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 |
|---|---|---|
| AtorvastatinAtorvastatin 80 mg tablet/day for 3 months | Drug | A |
Primary outcome
Changes in carotid plaque composition as assessed by MRI and histology
Time frame: 3 months
2 secondary outcomes
Changes content of cells, proteins and genes in carotid plaque
Time frame: 3 months
Changes in content of selected proteins and their encoding genes in carotid plaques
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2010.
- Background: PubMed 16888239Choudhary S, Higgins CL, Chen IY, Reardon M, Lawrie G, Vick GW 3rd, Karmonik C, Via DP, Morrisett JD. Quantitation and localization of matrix metalloproteinases and their inhibitors in human carotid endarterectomy tissues. Arterioscler Thromb Vasc Biol. 2006 Oct;26(10):2351-8. doi: 10.1161/01.ATV.0000239461.87113.0b. Epub 2006 Aug 3.
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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.
Joel D Morrisett, PhD principal investigator
Baylor College of Medicine
Addison M Taylor, MD, PhD study director
Baylor College of Medicine
William Insull, MD study chair
Baylor College of Medicine
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 Atorvastatin in people with Atherosclerosis, run by Baylor College of Medicine 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 9 inclusion and 5 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 7 Dec 2010. 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 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 William Insull, M.D. (713-798-4128, winsull@bcm.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in carotid plaque composition as assessed by MRI and histology (time frame: 3 months). 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 NCT00640744, 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 7 Dec 2010; AzTrials last refreshed its copy on 7 Nov 2026.