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Therapeutic Areas: Cardiology/Vascular Diseases
Disease Category: Circulation Disorders
Trial Information
Effect Of Clopidogrel Versus Placebo, On A Background Of Standard Care Including Aspirin, In Maintaining The Patency of Lower Limb Arteries After Angioplasty
Pain In Your Legs When Walking? It may Be Your Circulation.
Exciting New Research Study To Help Your Leg Circulation.
We are conducting a clinical research study to evaluate the
effectiveness and safety of a drug (clopidogrel) versus an inactive
compound (placebo) in keeping leg arteries open after a successful
angioplasty procedure has been performed. Everyone in the study
will receive aspirin and other standard treatments deemed
appropriate. Clopidogrel is a prescription pill that has been
approved by the Food and Drug Administration and has been shown to
prevent heart attacks and strokes in patients with leg circulation
problems. Clopidogrel has not been approved by the Food and Drug
Administration for patients who have undergone angioplasty in their
legs.
You may qualify for participation in this study if you have
circulation problems in your legs causing pain, cramping, aching,
heaviness, tiredness, discomfort, or numbness in the legs that is
caused by walking and relieved by stopping walking.
Approximately 2000 subjects at about 100 centers in the United
States who have leg circulation problems will be included in this
research program. Approximately 12 patients will be enrolled at
Mount Sinai Medical Center.
No Compensation Provided
Patient Inclusion/Exclusion Criteria:
1. Male or female of any race and age >40 years.
2. Has been diagnosed with Peripheral Arterial Disease
3. Has undergone successful Percutaneous Transluminal Angioplasty
of the leg
1. History of bleeding problems
2. Heart attack or stroke within the past 3 months
3. Major surgery within the prior 6 weeks.
4. Allergy or intolerance or contraindications to the use of
aspirin
5. Low platelet count
6. Uncontrolled high blood pressure
7. Severe kidney or liver disease
8. Pregnant women and women of child-bearing potential who are
nursing or who are not using an adequate method of birth
control.
9. Receiving chronic anticoagulation therapy
Patricia M. Mcmullen, RN, NP
Mount Sinai Medical Center
One Gustave L. Levy Place
New York, NY 10029
Phone: 212 241-0740
Fax: 212 241-5107
EMail: patricia.mcmullen@msnyuhealth.org
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If you would like to learn more about participating in this study, please send an e-mail message using the form below.
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