Peripheral Arterial DiseasePhase 4NCT00687076
Effectiveness of Intensive Lipid Modification Medication in Preventing the Progression of Peripheral Arterial Disease (The ELIMIT Study)
A Phase 4 study testing Ezetimibe, Niaspan and Statin therapy in people with Peripheral Arterial Disease, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Peripheral arterial disease (PAD) occurs when arteries become narrowed or hardened because of a build-up of plaque or fat deposits. PAD develops most often in arteries in the legs, which can result in reduced blood flow to the legs and feet, occasionally causing leg pain and fatigue. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Ezetimibe, Niaspan and Statin therapy
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Dec 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptoms consistent with calf claudication and described as life style limiting
- Objective evidence of peripheral artery disease (PAD): Ankle brachial index less than 0.9 OR other hemodynamic or imaging modalities confirming significant PAD
- Baseline imaging reveals superficial femoral artery (SFA) disease starting at least 5 cm from the origin of the SFA
- Agrees to be available for follow-up and is able to participate in all study testing procedures
- Weight and/or body characteristics that will allow testing with MRI
- No known contraindication to lipid lowering agents
Show all 10Show fewer
- Serum creatinine level less than 2.5 mg/dL
- Scheduled to undergo or has already undergone an endovascular intervention of a de novo lesion in the SFA with an anticipated result that would satisfy hemodynamic stability OR is medically managed and does not require an intervention at this time
- Compressible arteries (if not, has toe brachial index [TBI] less than 0.7)
- Has/had an A, B, C lesion amendable to a catheter based therapy (prior bypass is acceptable)
Who cannot join
- Non-atherosclerotic disease that is responsible for claudication
- Unstable cardiac disease (e.g., unstable angina, heart attack within the 30 days before study entry, uncontrolled coronary heart failure, poorly controlled hypertension [systolic blood pressure greater than 180 mmHg and/or diastolic blood pressure greater than 100 mmHg], ventricular arrhythmias)
- Pancreatitis
- Documented hypercoagulable state
- Clinically severe diabetic neuropathy
- Rest pain, gangrene, or tissue loss
Show all 21Show fewer
- Active peptic ulcer disease or a recent gastrointestinal bleed that would prohibit the use of an anti-platelet (aspirin/Plavix)
- Untreated or unsuccessfully controlled psychiatric disease
- Chronic hepatic disease determined by aspartate transaminase (AST) and/or alanine transaminase (ALT) more than 3 times upper limit of normal (ULN) and/or total bilirubin more than 2 times ULN
- Creatine phosphokinase (CPK) more than 3 times ULN (may be repeated once before patient is excluded)
- Active gout symptoms or a uric acid level greater than 1.3 times ULN
- Untreated hypothyroidism
- Allergy to Plavix, nickel, titanium, niacin, Ezetimibe, statins, or their derivatives
- Participated in another interventional study within the 30 days before study entry
- Scheduled to undergo planned synchronous bilateral percutaneous transluminal angioplasty (PTA) procedures
- Requires an above the ankle amputation
- Scheduled to undergo elective surgery within 30 days after the PTA procedure
- Has an implanted pacemaker, defibrillator, neural stimulator, brain clip, insulin pump, cochlear implant, or any other predetermined radiographic finding that would exclude MRI testing
- Has claustrophobia that would prevent MRI testing
- Recent drug or alcohol abuse history (less than 6 months before study entry) or is currently using or abusing excessive alcohol or drugs (excessive alcohol will be defined as greater than 14 drinks per week)
- Past recipient of a cardiac, kidney, liver, lung, or other organ transplant (skin grafts are acceptable)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Lipid Modification on Peripheral Arterial Disease After Endovascular Intervention ("The ELIMIT Trial")
Peripheral arterial disease (PAD) occurs when arteries become narrowed or hardened because of a build-up of plaque or fat deposits. PAD develops most often in arteries in the legs, which can result in reduced blood flow to the legs and feet, occasionally causing leg pain and fatigue. Early identification of PAD and treatment with lifestyle changes or medications can help to keep legs healthy and lower risk for heart attack and stroke, but endovascular or surgical procedures may be necessary for people with severe PAD. Even after endovascular intervention, PAD symptoms must be continually monitored to prevent the development and progression of blockages in the arteries. The best approach for monitoring symptoms is still undetermined. This study will compare the effectiveness of an intensive combination of lipid modifying medications versus standard lipid modifying medications in treating people with significant PAD who have had an endovascular intervention.
Read the detailed description
PAD occurring in the legs is a serious disease that affects about 8 million people in the United States. A person's risk for PAD increases with age but can also be raised by smoking or having diabetes, high blood pressure, high cholesterol, or heart disease. Symptoms of PAD may include leg cramps or pain while walking, foot pain while resting, and skin wounds or ulcers on feet and toes. However, because only about one in three people with PAD knows to seek treatment for these symptoms, many end up with advanced disease that requires significant medical intervention, such as an endovascular or other surgical procedure to open the blocked arteries. While these procedures are helpful in treating people with severe PAD, lifestyle modifications and certain medications are also needed for long-term management of PAD and improved quality of life. An intensive combination of lipid modifying medications may be superior to standard lipid modifying medications in reducing PAD-associated risk factors and improving overall health in people with PAD. This study will compare the effectiveness of an intensive combination of lipid modifying medications versus standard lipid modifying medications in preventing blockages and re-narrowing of arteries in people with significant PAD who have had an endovascular intervention.
Participation in this study will last a minimum of 2 years and a maximum of 5 years. All participants will first undergo baseline assessments that will include a medical history, vascular and physical exam, electrocardiograph (EKG), magnetic resonance imaging (MRI) scan, 3D ultrasound, blood pressure measurement test in the legs, treadmill walking distance test, urine test, blood draw, and questionnaires. A portion of the blood draw will be used for DNA analysis and genetic testing.
Participants who have not had an endovascular intervention in the 3 months before study entry will undergo a standard of care percutaneous transluminal angioplasty (PTA) procedure. First these, participants will complete a series of clinical review assessments that will include a review of social, vascular, and clinical history. Next, they will undergo the PTA procedure, which will involve the inflation and deflation of a small balloon in the area of the blocked artery. Additionally, participants may have a metal mesh tube called a stent placed in the blocked area, if deemed necessary by their physicians.
All participants will then be assigned randomly to receive standard care plus an intensive combination of lipid modifying medications (Simvastatin, Plavix, aspirin, Ezetimibe, and Niaspan) or standard lipid modifying medications with placebo (Simvastatin, Plavix, aspirin, placebo Ezetimibe, and placebo Niaspan). Participants will take their assigned medications daily for 24 months. Follow-up visits will occur at Day 10; Week 6; and Months, 6, 12, and 24 after beginning the study medications. During follow-up visits, participants will repeat the baseline assessments and the clinical review assessments from the pre-PTA visit. The Week 6 follow-up visit will include only a blood draw, questionnaires, and the clinical review assessments. Participants will also be contacted by phone to check their status every 2 to 3 months during treatment and every 6 months after treatment for up to 3 years.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Ezetimibe, Niaspan, Statin therapy, Standard care, Aspirin
- Keywords
- Endovascular Intervention, MRI, Ultrasound, Cholesterol Medications, High Cholesterol, Peripheral Arterial disease, Claudication, Leg Pain, Niaspan, Extended Release Niacin, Zetia, Ezetimibe, Simvastatin, Zocor, Atorvastatin, Lipitor
- Medical subject headings
- Peripheral Arterial Disease, Hypercholesterolemia, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EzetimibeDrug
Also called Zetia
Daily dose of 10 mg of Ezetimibe
NiaspanDrug
Also called Extended release niacin
Daily dose of 1500 mg of Niaspan
Statin therapyDrug
Also called Zocor, Liptior
Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)
Standard careBehavioural
Standard of medical care for PAD
AspirinDrug
Daily dose of 325 mg of aspirin
ClopidogrelDrug
Also called Plavix
Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician
Placebo NiaspanDrug
Daily dose of 1500 mg of placebo Niaspan
Placebo EzetimibeDrug
Daily dose of 10 mg of placebo Ezetimibe
Percutaneous transluminal angioplasty (PTA)Procedure or surgery
Also called Endovascular intervention
Participants who have not had an endovascular intervention in the 3 months before study entry will undergo PTA to mechanically open the artery blockages. This procedure will involve the inflation and deflation of a small balloon to open the blocked artery. Additionally, participants may have a metal mesh tube called a stent placed in the blocked area if deemed necessary by their physicians.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive standard of medical care and treatment with intensive lipid modification using a statin plus Ezetimibe and Niaspan. Receives: Drug: Ezetimibe; Drug: Niaspan; Drug: Statin therapy; Behavioral: Standard care; Drug: Aspirin; Drug: Clopidogrel; Procedure: Percutaneous transluminal angioplasty (PTA) |
| 2 | Active comparator | Participants will receive standard of medical care and treatment with standard lipid modifying medications plus placebo Ezetimibe and placebo Niaspan. Receives: Drug: Statin therapy; Behavioral: Standard care; Drug: Aspirin; Drug: Clopidogrel; Drug: Placebo Niaspan; Drug: Placebo Ezetimibe; Procedure: Percutaneous transluminal angioplasty (PTA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Intensive Lipid Modification Medication Therapy on Progression of Atherosclerosis and Restenosis of Femoral Arteries Measured Using High Resolution Magnetic Resonance Imaging (MRI) to Examine the Femoral Artery for Progression of Atherosclerosis
The primary outcome variable was the change in superficial femoral artery (SFA) wall volume over 24-months, as determined by MRI. The 24-month changes in SFA lumen and SFA total vessel volumes were also analyzed.
Analysis details: A total of 102 patients were randomized. 87 patients completed baseline MRI. Between randomization and the baseline visit, 1 patient withdrew from the study, 8 patients opted out from baseline imaging, and 6 additional patients declined blood collection at baseline. The multilevel models (primary endpoint) used all available imaging data (n=91), including patients who only completed baseline imaging (n=20) or completed at least 2 imaging visits other than baseline (n=4).
Measured: Measured at baseline and 24 Months
Secondary outcomes (1)
Change in Total Cholesterol (mg/dl) From Baseline to Month 12
Lipids: Total cholesterol (mg/dl); Lipid Data at 12-Months (change from baseline) [mg/dl].
Measured: Measured at baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2008 (estimated)
- Study startApr 2004
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Christie Ballantyne, Baylor College of Medicine
- Investigators
- Christie M. Ballantyne, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00687076
- Sponsor's protocol ID
- 1400
- Other IDs
- R01HL075824
- Status last verified
- Jan 2020
- First submitted
- 28 May 2008
- Last updated
- 6 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lumsden AB, Rice TW, Chen C, Zhou W, Lin PH, Bray P, Morrisett J, Nambi V, Ballantyne C. Peripheral arterial occlusive disease: magnetic resonance imaging and the role of aggressive medical management. World J Surg. 2007 Apr;31(4):695-704. doi: 10.1007/s00268-006-0732-y.
PubMed 17345122Brunner G, Yang EY, Kumar A, Sun W, Virani SS, Negi SI, Murray T, Lin PH, Hoogeveen RC, Chen C, Dong JF, Kougias P, Taylor A, Lumsden AB, Nambi V, Ballantyne CM, Morrisett JD. The Effect of Lipid Modification on Peripheral Artery Disease after Endovascular Intervention Trial (ELIMIT). Atherosclerosis. 2013 Dec;231(2):371-7. doi: 10.1016/j.atherosclerosis.2013.09.034. Epub 2013 Oct 16.
PubMed 24267254Saunders J, Nambi V, Kimball KT, Virani SS, Morrisett JD, Lumsden AB, Ballantyne CM, Dong JF; ELIMIT Investigators. Variability and persistence of aspirin response in lower extremity peripheral arterial disease patients. J Vasc Surg. 2011 Mar;53(3):668-75. doi: 10.1016/j.jvs.2010.08.029. Epub 2011 Jan 12.
PubMed 21227624
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lipid Modification on Peripheral Arterial Disease After Endovascular Intervention ("The ELIMIT Trial")
- ClinicalTrials.gov ID
- NCT00687076
- Acronym / sponsor ID
- 1400
- Conditions
- Peripheral Arterial Disease
- Keywords
- Endovascular Intervention, MRI, Ultrasound, Cholesterol Medications, High Cholesterol, Peripheral Arterial disease, Claudication, Leg Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Apr 2004
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 30 May 2008 (estimated)
- Results
- Posted 25 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Peripheral arterial disease (PAD) occurs when arteries become narrowed or hardened because of a build-up of plaque or fat deposits. PAD develops most often in arteries in the legs, which can result in reduced blood flow to the legs and feet, occasionally causing leg pain and fatigue. Early identification of PAD and treatment with lifestyle changes or medications can help to keep legs healthy and lower risk for heart attack and stroke, but endovascular or surgical procedures may be necessary for people with severe PAD. Even after endovascular intervention, PAD symptoms must be continually monitored to prevent the development and progression of blockages in the arteries. The best approach for monitoring symptoms is still undetermined. This study will compare the effectiveness of an intensive combination of lipid modifying medications versus standard lipid modifying medications in treating people with significant PAD who have had an endovascular intervention.
Detailed description
PAD occurring in the legs is a serious disease that affects about 8 million people in the United States. A person's risk for PAD increases with age but can also be raised by smoking or having diabetes, high blood pressure, high cholesterol, or heart disease. Symptoms of PAD may include leg cramps or pain while walking, foot pain while resting, and skin wounds or ulcers on feet and toes. However, because only about one in three people with PAD knows to seek treatment for these symptoms, many end up with advanced disease that requires significant medical intervention, such as an endovascular or other surgical procedure to open the blocked arteries. While these procedures are helpful in treating people with severe PAD, lifestyle modifications and certain medications are also needed for long-term management of PAD and improved quality of life. An intensive combination of lipid modifying medications may be superior to standard lipid modifying medications in reducing PAD-associated risk factors and improving overall health in people with PAD. This study will compare the effectiveness of an intensive combination of lipid modifying medications versus standard lipid modifying medications in preventing blockages and re-narrowing of arteries in people with significant PAD who have had an endovascular intervention.
Participation in this study will last a minimum of 2 years and a maximum of 5 years. All participants will first undergo baseline assessments that will include a medical history, vascular and physical exam, electrocardiograph (EKG), magnetic resonance imaging (MRI) scan, 3D ultrasound, blood pressure measurement test in the legs, treadmill walking distance test, urine test, blood draw, and questionnaires. A portion of the blood draw will be used for DNA analysis and genetic testing.
Participants who have not had an endovascular intervention in the 3 months before study entry will undergo a standard of care percutaneous transluminal angioplasty (PTA) procedure. First these, participants will complete a series of clinical review assessments that will include a review of social, vascular, and clinical history. Next, they will undergo the PTA procedure, which will involve the inflation and deflation of a small balloon in the area of the blocked artery. Additionally, participants may have a metal mesh tube called a stent placed in the blocked area, if deemed necessary by their physicians.
All participants will then be assigned randomly to receive standard care plus an intensive combination of lipid modifying medications (Simvastatin, Plavix, aspirin, Ezetimibe, and Niaspan) or standard lipid modifying medications with placebo (Simvastatin, Plavix, aspirin, placebo Ezetimibe, and placebo Niaspan). Participants will take their assigned medications daily for 24 months. Follow-up visits will occur at Day 10; Week 6; and Months, 6, 12, and 24 after beginning the study medications. During follow-up visits, participants will repeat the baseline assessments and the clinical review assessments from the pre-PTA visit. The Week 6 follow-up visit will include only a blood draw, questionnaires, and the clinical review assessments. Participants will also be contacted by phone to check their status every 2 to 3 months during treatment and every 6 months after treatment for up to 3 years.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Ezetimibe, Drug: Niaspan, Drug: Statin therapy, Behavioral: Standard care, Drug: Aspirin, Drug: Clopidogrel, Procedure: Percutaneous transluminal angioplasty (PTA)Participants will receive standard of medical care and treatment with intensive lipid modification using a statin plus Ezetimibe and Niaspan. |
| 2 | Active comparator | Drug: Statin therapy, Behavioral: Standard care, Drug: Aspirin, Drug: Clopidogrel, Drug: Placebo Niaspan, Drug: Placebo Ezetimibe, Procedure: Percutaneous transluminal angioplasty (PTA)Participants will receive standard of medical care and treatment with standard lipid modifying medications plus placebo Ezetimibe and placebo Niaspan. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Symptoms consistent with calf claudication and described as life style limiting
- Objective evidence of peripheral artery disease (PAD): Ankle brachial index less than 0.9 OR other hemodynamic or imaging modalities confirming significant PAD
- Baseline imaging reveals superficial femoral artery (SFA) disease starting at least 5 cm from the origin of the SFA
- Agrees to be available for follow-up and is able to participate in all study testing procedures
- Weight and/or body characteristics that will allow testing with MRI
Key exclusion criteria (21 listed)
- Non-atherosclerotic disease that is responsible for claudication
- Unstable cardiac disease (e.g., unstable angina, heart attack within the 30 days before study entry, uncontrolled coronary heart failure, poorly controlled hypertension [systolic blood pressure greater than 180 mmHg and/or diastolic blood pressure greater than 100 mmHg], ventricular arrhythmias)
- Pancreatitis
- Documented hypercoagulable state
- Clinically severe diabetic neuropathy
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 |
|---|---|---|
| EzetimibeAlso: ZetiaDaily dose of 10 mg of Ezetimibe | Drug | 1 |
| NiaspanAlso: Extended release niacinDaily dose of 1500 mg of Niaspan | Drug | 1 |
| Statin therapyAlso: Zocor, LiptiorDaily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.) | Drug | 1, 2 |
| Standard careStandard of medical care for PAD | Behavioural | 1, 2 |
| AspirinDaily dose of 325 mg of aspirin | Drug | 1, 2 |
| ClopidogrelAlso: PlavixDaily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician | Drug | 1, 2 |
| Placebo NiaspanDaily dose of 1500 mg of placebo Niaspan | Drug | 2 |
| Placebo EzetimibeDaily dose of 10 mg of placebo Ezetimibe | Drug | 2 |
| Percutaneous transluminal angioplasty (PTA)Also: Endovascular interventionParticipants who have not had an endovascular intervention in the 3 months before study entry will undergo PTA to mechanically open the artery blockages. This procedure will involve the inflation and deflation of a small balloon to open the blocked artery. Additionally, participants may have a metal mesh tube called a stent placed in the blocked area if deemed necessary by their physicians. | Procedure or surgery | 1, 2 |
Primary outcome
Effect of Intensive Lipid Modification Medication Therapy on Progression of Atherosclerosis and Restenosis of Femoral Arteries Measured Using High Resolution Magnetic Resonance Imaging (MRI) to Examine the Femoral Artery for Progression of Atherosclerosis
Time frame: Measured at baseline and 24 Months
The primary outcome variable was the change in superficial femoral artery (SFA) wall volume over 24-months, as determined by MRI. The 24-month changes in SFA lumen and SFA total vessel volumes were also analyzed. Analysis details: A total of 102 patients were randomized. 87 patients completed baseline MRI. Between randomization and the baseline visit, 1 patient withdrew from the study, 8 patients opted out from baseline imaging, and 6 additional patients declined blood collection at baseline. The multilevel models (primary endpoint) used all available imaging data (n=91), including patients who only completed baseline imaging (n=20) or completed at least 2 imaging visits other than baseline (n=4).
1 secondary outcome
Change in Total Cholesterol (mg/dl) From Baseline to Month 12
Time frame: Measured at baseline and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17345122Lumsden AB, Rice TW, Chen C, Zhou W, Lin PH, Bray P, Morrisett J, Nambi V, Ballantyne C. Peripheral arterial occlusive disease: magnetic resonance imaging and the role of aggressive medical management. World J Surg. 2007 Apr;31(4):695-704. doi: 10.1007/s00268-006-0732-y.
- Results publication: PubMed 24267254Brunner G, Yang EY, Kumar A, Sun W, Virani SS, Negi SI, Murray T, Lin PH, Hoogeveen RC, Chen C, Dong JF, Kougias P, Taylor A, Lumsden AB, Nambi V, Ballantyne CM, Morrisett JD. The Effect of Lipid Modification on Peripheral Artery Disease after Endovascular Intervention Trial (ELIMIT). Atherosclerosis. 2013 Dec;231(2):371-7. doi: 10.1016/j.atherosclerosis.2013.09.034. Epub 2013 Oct 16.
- Results publication: PubMed 21227624Saunders J, Nambi V, Kimball KT, Virani SS, Morrisett JD, Lumsden AB, Ballantyne CM, Dong JF; ELIMIT Investigators. Variability and persistence of aspirin response in lower extremity peripheral arterial disease patients. J Vasc Surg. 2011 Mar;53(3):668-75. doi: 10.1016/j.jvs.2010.08.029. Epub 2011 Jan 12.
- Click here for more information on peripheral arterial diseaseLink provided by the sponsor.
- Click here for more information on peripheral arterial diseaseLink provided by the sponsor.
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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.
Christie M. Ballantyne, MD principal investigator
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 Ezetimibe, Niaspan and Statin therapy in people with Peripheral Arterial Disease, 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 10 inclusion and 21 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 6 Feb 2020. 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?
Yes. Results are posted in the registry (first posted 25 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Effect of Intensive Lipid Modification Medication Therapy on Progression of Atherosclerosis and Restenosis of Femoral Arteries Measured Using High Resolution Magnetic Resonance Imaging (MRI) to Examine the Femoral Artery for Progression of Atherosclerosis (time frame: Measured at baseline and 24 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 NCT00687076, which also lists 3 linked publications.
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 Feb 2020.