Peripheral Arterial Disease Clinical Trial
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.
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.
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