Effectiveness of Intensive Lipid Modification Medication in Preventing the Progression of Peripheral Arterial Disease (The ELIMIT Study)
Information source: Baylor College of Medicine
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Peripheral Arterial Disease
Intervention: Ezetimibe (Drug); Niaspan (Drug); Statin therapy (Drug); Standard care (Behavioral); Aspirin (Drug); Clopidogrel (Drug); Placebo Niaspan (Drug); Placebo Ezetimibe (Drug); Percutaneous transluminal angioplasty (PTA) (Procedure)
Phase: Phase 4
Status: Completed
Sponsored by: Baylor College of Medicine Official(s) and/or principal investigator(s): Christie M. Ballantyne, MD, Principal Investigator, Affiliation: Baylor College of Medicine
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. 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.
Clinical Details
Official title: Effect of Lipid Modification on Peripheral Arterial Disease After Endovascular Intervention ("The ELIMIT Trial")
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Health Services Research
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
Secondary outcome: Change in Total Cholesterol (mg/dl) From Baseline to Month 12Effect of Intensive Lipid Modification Medication Therapy on Thrombosis, and Relationship to PAD Progression, Restenosis, and Clinical Events
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.
Eligibility
Minimum age: 40 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
- 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)
Exclusion Criteria:
- 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
- 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)
Locations and Contacts
Baylor College of Medicine, Houston, Texas 77030, United States
Additional Information
Click here for more information on peripheral arterial disease Click here for more information on peripheral arterial disease Click here for more information about this study at Baylor College of Medicine's Section of Atherosclerosis and Vascular Medicine
Related 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. Review.
Starting date: April 2004
Last updated: August 7, 2014
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